Peter Kiencke

Validation of the German version of the Brief Pain Inventory.

The Brief Pain Inventory is a comprehensive instrument for pain assessment and has been validated in several languages. A validated German version was not available until now. From March to May 1995 all outpatients of the pain clinic of the Department of Anesthesiology completed a questionnaire with the German versions of the Brief Pain Inventory (BPI) and the SF-36 quality-of-life questionnaire. The BPI was repeated after the consultation. The physician assessed the performance status score of the Eastern Cooperative Oncology Group (ECOG). The questionnaire was completed by 151 patients. Forty-two patients were excluded from evaluation for methodological reasons, so 109 patients were evaluated. As in the original version of the BPI, factor analysis showed a common factor for pain intensity and a second factor for pain-related interference with function. The comparative fit index of 0.86 confirmed this model. Responses before and after consultation correlated closely for the sum scores of the pain intensity items (Perarson correlation r = 0.976) as well as for the interference with function items (r = 0.974). Pain intensity in the BPI correlated with bodily pain in the SF-36 (r = 0.585). Sum scores of the pain interference items were higher in patients with deteriorated ECOG performance status, whereas sum scores of the intensity items were not changed. Validity and reliability of the German BPI were comparable to the original version. The BPI may be advantageous for palliative care patients, as it places only a small burden on the patient and offers easy criteria for evaluation. However, further research is needed to differentiate the impact of pain-related and disease-related interference with function on the BPI, and to find an algorithm for the evaluation of the BPI when values are missing.

Clinical equivalence of IV paracetamol compared to IV dipyrone for postoperative analgesia after surgery for breast cancer

ABSTRACT Objective: To assess clinical efficacy of IV paracetamol 1 g and IV dipyrone 1 g on a 24.h dosing schedule in this randomised, double-blinded study of 40 ASA I–III (American Society of Anesthesiologists classification of physical status) patients undergoing surgery for breast cancer. Research design and methods: General anaesthesia using remifentanil and propofol was performed for surgery. The patients were randomly allocated to two groups, receiving infusions of paracetamol 1 g/100 mL (Para Group) or of dipyrone 1 g/100 mL (Dipy Group) 30 min before arrival in the recovery area and every 6 h up to 24 h postoperatively. All patients had unrestricted access to opioid rescue medication via an IV patient-controlled analgesia (PCA) device. Main outcome measures: The primary variables for clinical equivalence were the differences between the mean values for pain scores at rest and pain scores on coughing over 30 h postoperatively. The equivalence margin was determined as ±10 mm on the visual analogue scale (VAS). Results: Regarding pain scores at rest, the 90% CI of the mean differences between the treatment groups over 30 h postoperatively was found to be within the predefined equivalence margin [+7.5/–6.2], and the CI values for pain scores on coughing [+7.3/–9.0] were similar. The two groups did not differ in cumulative opioid rescue consumption (Dipy-Group 14.8 ± 17.7 mg vs. Para Group 12.1 ± 8.8 mg, p = 0.54) nor in piritramide loading dose (Dipy Group 0.95 ± 2.8 mg vs. Para Group 1.3 ± 2.8 mg, p = 0.545). Five patients in the Dipy Group experienced hypotension in contrast to none in the Para Group ( p = 0.047). There were no significant between-treatment differences for other adverse events, patient satisfaction scores ( p = 0.4) or quality of recovery scores ( p = 0.3). Conclusion: IV paracetamol 1 g is clinically equivalent to IV dipyrone 1 g for postoperative analgesia after surgery for breast cancer.

A comparison between IV paracetamol and IV metamizol for postoperative analgesia after retinal surgery

ABSTRACT Objective: To assess clinical efficacy of IV paracetamol 1 g and IV metamizol 1 g on a 24‐h dosing schedule in this randomized, double-blinded, placebo-controlled study of 38 ASA physical status I–III patients undergoing retinal surgery. Research design and methods: General anaesthesia using remifentanil, propofol, and desflurane was performed for surgery. The patients were randomly allocated to three groups, receiving infusions of paracetamol 1 g/100 mL (Para Group), of metamizol 1 g/100 mL (Meta Group), or of 100 mL of saline solution as placebo control (Plac Group) 30 min before arrival in the recovery area and every 6 h up to 24 h postoperatively. All patients had unrestricted access to intravenous opioid rescue medication. Main outcome measures: The primary efficacy variables were pain scores at rest over 30 h postoperatively analysed by using repeated ANOVA measurement. Secondary efficacy variables were pain scores on coughing, also analysed by repeated ANOVA measurement. Results: Five patients in the Plac Group and one patient in the Meta Group interrupted the study protocol. Regarding pain scores at rest, Mauchly-test of sphericity was significant ( p = 0.03). For the time effects a significant result was detected ( p < 0.001). The main effect between the three treatment groups was significantly different ( p = 0.01). The Bonferroni adjusted pair wise comparisons between the Plac Group and the Para Group showed a significant difference in favour of IV paracetamol ( p = 0.024; mean difference 14.8; 95% CI 1.6–28.0), between the Plac Group and the Meta Group in favour of IV metamizol ( p = 0.025; mean difference 14.4; 95% CI 1.5–27.4), and no significant difference between the Para Group and the Meta Group ( p = 1.0; mean difference 0.4; 95% CI –12.8 to 13.6). Pain scores on coughing showed a significant different main effect between the three treatment groups ( p = 0.022). The Bonferroni adjusted pair wise comparisons between the Plac Group and the Para Group showed a significant difference in favour of IV paracetamol ( p = 0.032; mean difference 17.9; 95% CI 1.3–34.6), a difference, though not reaching statistical significance, in favour of IV metamizol between the Plac Group and the Meta Group ( p = 0.081; mean difference 15.0; 95% CI –1.4 to 31.4), and no significant difference between the Para Group and the Meta Group ( p = 1.0; mean difference 2.9; 95% CI –13.8 6 to 19.6). None of the patients experienced itching; one patient in the Meta Group developed a mild erythema. There was no statistical difference in the incidence of nausea (Plac vs. Para Group: p = 0.94, Plac vs. Meta Group: p = 0.98, Para vs Meta Group: p = 0.95) or vomiting (Plac vs. Para Group: p = 0.73, Plac vs. Meta Group: p = 0.85, Para vs Meta Group: p = 0.86) between the groups. Patients in the Plac Group experienced significantly more often sedation than patients in the Meta Group ( p = 0.049). There was a trend of higher sedation in the Plac Group than in the Para Group, which did not reach statistical significance ( p = 0.07). There was no difference in sedation between the Meta and the Para Groups ( p = 0.84). Conclusion: IV paracetamol 1 g has a similar analgesic potency as IV metamizol 1 g for postoperative analgesia after retinal surgery.

Training as a Prerequisite for Reliable Use of NIH Stroke Scale

To the Editor: Before new therapies for ischemic stroke are established, their safety and effectiveness must be proved. In particular, the numerous multicenter acute stroke trials currently being performed require a valid, efficient, and reliable measure of patient status and outcome after treatment. Interrater variation in the assessment of neurological deficits could imply that important effects of the treatment remain concealed, which in turn may have a misleading influence on therapeutic decisions. A commonly used yardstick for measuring the outcome of neurological deficits in stroke patients is the National Institutes of Health Stroke Scale (NIHSS).1 2 3 Not only experienced neurologists can reliably apply the NIHSS; it can be used as well by nonneurologists or even nonphysicians (eg, study nurses),4 5 6 7 provided the raters are well trained and given detailed instructions. As far as the NINDS study is concerned, the investigators were video trained and required to take an examination.1 The question, however, of whether the NIHSS provides precise and reliable data when applied without an intensive training program has not yet been raised. We therefore investigated the reliability of the NIHSS as used by trained and untrained raters in 22 stroke patients in the Neurological Department at …

Epidural block with ropivacaine and bupivacaine for elective caesarean section: maternal cardiovascular parameters, comfort and neonatal well-being*

SUMMARY Objective: To determine cardiovascular effects and neonatal outcome of ropivacaine 0.75% and bupivacaine 0.5% for elective epidural caesarean section. Research design and methods: Healthy pregnant women, scheduled for elective caesarean section, were enrolled in this randomised, double-blind study. Epidural block was obtained with 20-30 ml of ropivacaine 0.75% (Group R) or bupivacaine 0.5% (Group B) and surgery did not commence until anaesthesia was achieved bilaterally to T6. Main outcome measures: Maternal heart rate and blood pressure were assessed before the main dose of local anaesthetic and at 5-min intervals until 35 min. Neonatal umbilical pH and Apgar scores were determined after delivery. Ten, twenty and thirty minutes after the main dose, sensory and motor block characteristics were determined. Quality of analgesia was assessed by the anaesthetist, surgeon and the patient. Adverse events were recorded. Results: Sixty-two patients were enrolled and the data of 60 of them were eligible for analysis: 31 in Group R and 29 in Group B. The area under the curve (AUC) for maternal heart rate decreased significantly less in Group B than in Group R (p = 0.038). Twenty-five and thirty minutes after administration of the main local anaesthetic dose, heart rate decreased significantly less in Group B than in Group R (p = 0.006 and p = 0.007). There was no difference in AUC for maternal blood pressure (p = 0.32). Repeated measurement analysis showed no difference between groups in motor block (p = 0.78) and in spread of the sensory block (lower level: p = 0.83, upper level: p = 0.88). There was no statistical difference in neonatal umbilical pH (p = 0.22) and Apgar score (p = 0.59). Multiple linear regression analysis showed a significant influence of maternal body mass index on neonatal pH (p = 0.004), but not of maternal blood pressure (p = 0.323), nor of maternal heart rate (p = 0.12). The quality of analgesia and incidence of adverse events were similar in both groups. Conclusions: Both drugs produced equally satisfactory epidural block. Although ropivacaine 0.75% resulted in a greater decrease of maternal heart rate, this effect did not influence neonatal well-being. Both ropivacaine 0.75% and bupivacaine 0.5% can therefore be recommended for epidural anaesthesia in elective caesarean section.

Clinical efficacy of controlled-release oxycodone 20 mg administered on a 12-h dosing schedule on the management of postoperative pain after breast surgery for cancer.

SUMMARY Objective: To assess clinical efficacy of controlled-release oxycodone (CRO) 20 mg on a 12-h dosing schedule in this prospective, randomised, placebo-controlled, double-blinded study of 40 ASA physical status I-III women undergoing breast surgery for cancer. Research design and methods: General anaesthesia using remifentanil and propofol was performed for surgery. Both groups received premedication with oral midazolam 7.5 mg 1 h before surgery. In the controlled-release oxycodone group, one tablet of 20 mg CRO was administered with the premedication, and 12 h after the premedication another 20 mg CRO. In the placebo (PL) group, a placebo tablet was administered with the premedication, and 12 h later another placebo tablet. All patients had access to opioid rescue medication via an IV patient-controlled analgesia (PCA) device. Main outcome measures: Area under the curve (AUC), based on IV opioid rescue consumption over 24 h postoperatively. Results: The AUC for IV PCA opioid consumption was significantly lower in the CRO group than in the PL group (p = 0.01). The CRO group required less IV opioid loading dose (p < 0.001), and consumed less opioid rescue medication 4h (p = 0.036), 16h (p = 0.01), and 24 h (p = 0.005) postoperatively. AUC for VAS scores at rest was significantly lower in the CRO group than in the PL group (p = 0.05). VAS scores at rest were lower in the CRO group 16 h (p = 0.04) and 24h (p = 0.03) postoperatively. There was no difference in AUC for pain scores on movement (p = 0.103) and for quality of analgesia (p = 0.139). There was no difference in nausea between groups (p = 0.34). Pruritus, arterial hypotension or hypertension, bradycardia, and tachycardia were not observed in either treatment group. None of the patients showed signs of confusion, agitation, or respiratory depression. Conclusion: The administration of CRO 20 mg on a 12-h dosing schedule halves postoperative IV PCA opioid consumption. CRO 20mg is effective in preventing pain after breast surgery for cancer with only mild side-effects.

Current practice in postoperative epidural analgesia: A German survey

We surveyed current German practice in postoperative epidural analgesia (EA). Of 300 questionnaires sent anonymously, 147 (49%) were returned fully completed. A 24-h acute pain service (APS) was offered in 41% of German hospitals. Seventy percent of the large teaching hospitals (>1000 beds) offered an APS, whereas just 9% of the hospitals of <500 beds provided an APS. Small-size hospitals (<200 beds) preferred ropivacaine as the local anesthetic (LA) in contrast to large teaching hospitals using more bupivacaine than ropivacaine. In the general ward setting, 36% of the respondents used plain LA, and 64% combined the LA with an opioid. If ropivacaine was used, 0.2% was the most popular concentration (78%), combined with morphine (17%), fentanyl (14%), or sufentanil (75%). If bupivacaine was used, 0.25% was the preferred concentration (30%), combined with morphine (40%), fentanyl (8%), or sufentanil (60%). On wards, 58% of German anesthetic departments used continuous epidural infusion, 57% bolus doses, and 20% patient-controlled EA mode. We conclude that the availability of a 24-h APS (41%) in German hospitals corresponds favorably to international data. EA with the combination of LAs and opioids was the most common modality in the ward setting.

The continuous epidural infusion of ropivacaine 0.1% with 0.5 μg·mL−1 sufentanil provides effective postoperative analgesia after total hip replacement: a pilot study

PurposeTo assess the analgesic efficacy and functional outcome of postoperative epidural infusion of ropivacaine combined with sufentanil in a randomized, controlled trial.MethodsThirty-two ASA I–III patients undergoing elective total hip replacement (THR) were included. Lumbar epidural block using 0.75% ropivacaine was combined with either propofol sedation or general anesthesia for surgery. On arrival in the recovery room, the epidural infusion was commenced at a rate in mL calculated as follows: (height in cm −100) × 0.1. Eleven patients received an epidural infusion of ropivacaine 0.1 % with 0.5 μg·mL−1 sufentanil (Group R+S0.5), ten patients ropivacaine 0.1% with 0.75 μg·mL−1 sufentanil (Group R+S0.75), and 11 patients ropivacaine 0.1% with 1 μg·mL−1 sufentanil (Group R+S1) over a postoperative study period of 44 hr. All patients had access to iv piritramide via a patient-controlled analgesia (PCA) device. Postel-Merle-d’Aubigné scoring system (PMA score) was assessed preoperatively, three weeks after surgery, and three months after surgery by an orthopedic surgeon blinded to study group.ResultsMotor block was negligible in all three groups. After eight hours of epidural infusion, sensory block had regressed completely in all patients. There was no significant difference with regard to visual analogue scale (VAS) scores (at rest:P = 0.55, on movement:P = 0.63), consumption of rescue medication (P = 0.99), patient satisfaction (P = 0.22), and the incidence of adverse events. All treatment regimens provided effective postoperative analgesia with only a minimal use of supplemental opioid PCA. There was no difference between groups regarding orthopedic PMA score (pain:P = 0.24, mobility:P = 0.65, and ability to walk:P = 0.44).ConclusionRopivacaine 0.1% with 0.5 μg·mL−1 sufentanil for postoperative analgesia after THR provides efficient pain relief and, compared with 0.75 and 1 μg·mL−1 sufentanil, reduces sufentanil consumption without compromise in patient satisfaction, VAS scores, and functional outcome.RésuméObjectifÉvaluer, par une étude randomisée et contrôlée, l’efficacité analgésique et les effets fonctionnels d’une perfusion péridurale postopératoire de ropivacaïne combinée au sufentanil.MéthodeL’étude a été menée auprès de 32 patients d’état physique ASA I–III, devant subir une arthroplastie totale de hanche (ATH). Le bloc péridural lombaire réalisé avec de la ropivacaïne à 0,75 %, a été combiné à une sédation au propofol ou à une anesthésie générale pour l’intervention chirurgicale. La perfusion péridurale, débutée dès l’arrivée en salle de réveil, avait un débit en mL calculé comme suit : (la taille en cm −100) × 0,1. Onze patients ont reçu une perfusion péridurale de ropivacaïne à 0,1 % combinée à 0,5 μg·mL−1 de sufentanil (Groupe R+S0,5), dix ont eu de la ropivacaïne à 0,1 % et 0,75μg·mL−1 de sufentanil (Groupe R+S0,75) et onze, de la ropivacaïne à 0,1 % avec 1 μg·mL−1 de sufentanil (Groupe R+S1) pendant les 44 h postopératoires de l’étude. Tous les patients avaient accès à une analgésie autocontrôlée (AAC) iv avec piritramide. Le score de Postel-Merle d’Aubigné (score PMA) a été évalué avant l’opération, trois semaines et trois mois après l’opération, par un chirurgien orthopédique impartial.RésultatsLe blocage moteur a été négligeable dans les trois groupes. Après huit heures de perfusion péridurale, le bloc sensitif avait complètement régressé chez tous les patients. Il n’y a pas eu de différence significative des scores de l’échelle visuelle analogique (au repos : P = 0,55, au mouvement : P = 0,63), de consommation de médication de secours (P = 0,99), de satisfaction des patients (P = 0,22) et d’incidence d’événements indésirables. Tous les schémas posologiques ont produit une analgésie postopératoire efficace et n’ont nécessité qu’un usage minimal d’opioïde supplémentaire en AAC. Le score orthopédique PMA était similaire entre les groupes (douleur : P = 0,24, mobilité : P = 0,65 et capacité de marcher : P = 0,44).ConclusionDe la ropivacaïne à 0,1 % combinée à 0,5μg·mL−1 de sufentanil, utilisée comme analgésie postopératoire après une ATH, réduit efficacement la douleur et, comparé à 0,75 et 1 μg·mL−1 de sufentanil, réduit la consommation de sufentanil sans compromettre la satisfaction des patients, les scores à l’EVA et les effets fonctionnels.

Epidural combination of ropivacaine with sufentanil for postoperative analgesia after total knee replacement: a pilot study

Background and objective: We assessed the analgesic efficacy of postoperative epidural infusions of ropivacaine 0.1 and 0.2% combined with sufentanil 1 μg mL−1 in a prospective, randomized, double-blinded study. Methods: Twenty-two ASA I-III patients undergoing elective total-knee replacement were included. Lumbar epidural blockade using ropivacaine 0.75% was combined with either propofol sedation or general anaesthesia for surgery. After surgery, the epidural infusion was commenced. Eleven patients in each group received either an epidural infusion of ropivacaine 0.1% with 1 μg mL−1 sufentanil (Group 1) or ropivacaine 0.2% with 1 μg mL−1 sufentanil (Group 2) at a rate of 5-9 mL h−1. All patients had access to intravenous pirinatrimide (piritramide) via a patient-controlled analgesia (PCA) device. Results: Motor block was negligible for the study duration in both groups. There was no significant difference with the 100 mm visual analogue scale (VAS) scores, with the consumption of rescue analgesia or with patient satisfaction. Patients in Group 1 experienced significantly less nausea (P < 0.05) than those in Group 2. Both treatment regimens provided effective postoperative analgesia with only a minimal use of supplemental opioid PCA. Conclusions: We recommend the use of ropivacaine 0.1% with 1 μg mL−1 sufentanil for postoperative analgesia after total knee replacement as it provides efficient pain relief with no motor block of the lower limbs. In addition, compared with 0.2% ropivacaine with sufentanil, the mixture reduces local anaesthetic consumption without compromise in patient satisfaction or VAS scores. Patients even experience less nausea.

Die Entwicklung der autologen Bluttransfusion in den alten Bundesländern der Bundesrepublik Deutschland von 1989 bis 1993 Teil 1: Eine Verlaufsbeobachtung an 143 Krankenhäusern

ZusammenfassungIn der Arbeit wird die jüngere Entwicklung der autologen Bluttransfusion in 143 Krankenhäusern aus den alten Bundesländern dargestellt. Die Daten stammen aus zwei in den Jahren 1989 bis 1993 von uns durchgeführten Fragebogenerhebungen. Der Anteil der Krankenhäuser, in denen eine präoperative Eigenblutspende möglich war, ist von 74% auf 89% und der Anteil der Krankenhäuser, in denen sie „häufig“ oder „meistens“ durchgeführt wurde, von 25% auf 45% angestiegen (20% bzw. 80% Zuwachs). Die Verbreitung der präoperativen Plasmapherese hat sich mehr als verdoppelt: 1989 wurde sie in 8% und 1993 in 19% der Krankenhäuser eingesetzt. Der Anteil der Krankenhäuser, in denen eine akute isovolämische Hämodilution durchgeführt wurde, ist von 62% auf 82% angestiegen (32% Zuwachs). Der Anteil der Krankenhäuser, in denen Zellseparatoren zur Verfügung standen, hat von 35% auf 45% zugenommen (29% Zuwachs). Die Transfusionspraxis hat sich, gemessen an der Akzeptanz postoperativer Hämoglobinwerte unter 10,0 g/dl, kaum gewandelt. Die Entwicklung der autologen Bluttransfusion in den 143 Krankenhäusern ist für die alten Bundesländer nicht repräsentativ. Sie gestattet aber Rückschlüsse auf die allgemeine Entwicklung der autologen Bluttransfusion in den alten Bundesländern.AbstractIncreased perception of the risks of homologous blood transfusion has focused substantial interest on autologous blood transfusion (ABT). To evaluate the role of ABT in the Federal Republic of Germany (FRG), we conducted postal surveys of German hospitals in 1989 and 1993. In the present study, the responses of 143 hospitals in the “old” federal states (former West Germany) that replied to both of our surveys were analysed. The objective was to examine trends in ABT practice in the FRG from 1989 to 1993. The study was restricted to the “old” federal states because data for the “new” federal states (former German Democratic Republic) were not available for that period. Methods. Data presented in this study were obtained by postal surveys of German hospitals in 1989 and 1993. Because of German reunification (3 October 1990), only hospitals in the “old” federal states were surveyed in 1989, while hospitals in both the “old” and “new” states were included in 1993. Four hundred randomly selected hospitals in the “old” federal states were included in both surveys, 143 of which responded to both. The completed questionaires of these 143 hospitals were analysed. In addition, to estimate the magnitude of positive selection bias, the data provided by these 143 hospitals were compared with data provided by another set of 162 hospitals in the “old” federal states that replied to the 1993 but not to the 1989 survey. Results. There were no significant changes from 1989 to 1993 in the 143 hospitals with respect to hospital size by number of beds and spectrum of surgical specialties. The proportion of hospitals that performed preoperative autologous blood donation grew by 20% (from 74% to 89%) and the proportion that used this technique regularly (“frequently” and “mostly”) rose by 80% (from 25% to 45%). The percentage of hospitals that performed preoperative plasmapheresis had more than doubled (from 8% to 19%). The proportion that used acute isovolaemic haemodilution grew by 32% (from 62% to 82%), while those doing so regularly (“frequently” and “mostly”) increased by only 17% (from 23% to 27%). The fraction of hospitals equipped with cell-washing devices grew by 29% (from 35% to 45%). General transfusion practice, as measured by acceptance of postoperative haemoglobin levels of less than 10.0g/dl, had changed but little. Conclusions. Although the 143 hospitals are not representative on a national level, the findings of our study allow some conclusions on general trends in the “old” states of the FRG. The potential for ABT has substantially grown in the “old” states from 1989 to 1993, although more consistent advantage of this potential could be taken.