Marta Somaini

Intraperitoneal ropivacaine nebulization for pain management after laparoscopic cholecystectomy: a comparison with intraperitoneal instillation

BACKGROUND: Studies evaluating intraperitoneal local anesthetic instillation for pain relief after laparoscopic procedures have reported conflicting results. In this randomized, double-blind study we assessed the effects of intraperitoneal local anesthetic nebulization on pain relief after laparoscopic cholecystectomy. METHODS: Patients undergoing elective laparoscopic cholecystectomy were randomly assigned to receive either instillation of ropivacaine 0.5%, 20 mL after induction of the pneumoperitoneum, or nebulization of ropivacaine 1%, 3 mL before and after surgery. Anesthetic and surgical techniques were standardized. Degree of pain at rest and on deep breathing, incidence of shoulder pain, morphine consumption, unassisted walking time, and postoperative nausea and vomiting were evaluated at 6, 24, and 48 hours after surgery. RESULTS: Of the 60 patients included, 3 exclusions occurred for conversion to open surgery. There were no differences between groups in pain scores or in morphine consumption. No patients in the nebulization group presented significant shoulder pain in comparison with 83% of patients in the instillation group (absolute risk reduction −83, 95% CI −97 to −70, P < 0.001). Nineteen (70%) patients receiving nebulization walked without assistance within 12 hours after surgery in comparison with 14 (47%) patients receiving instillation (absolute risk reduction −24, 95% CI −48 to 1, P = 0.04). One (3%) patient in the instillation group vomited in comparison with 6 (22%) patients in the nebulization group (absolute risk reduction −19%, 95% CI −36 to −2, P = 0.03). CONCLUSIONS: Intraperitoneal ropivacaine nebulization was associated with reduced shoulder pain and unassisted walking time but with an increased incidence of postoperative vomiting after laparoscopic cholecystectomy.

The effect of fentanyl and clonidine on early postoperative negative behavior in children: a double‐blind placebo controlled trial

Early negative postoperative behavior (e‐PONB) is common in children and manifests itself as emergence agitation (EA), emergence delirium (ED), and pain. The objective of this prospective double blind, randomized, placebo‐controlled trial was to determine whether IV clonidine or IV fentanyl prior to surgery modifies e‐PONB in children.

Emergence delirium, pain or both? a challenge for clinicians

Children commonly display early postoperative negative behavior (e‐PONB) after general anesthesia, which includes emergence delirium (ED), discomfort, temperament, and pain. However, it is often difficult for the caregiver to discriminate between various aspects of e‐PONB.

Postoperative Analgesia after Laparoscopic Ovarian Cyst Resection: Double-blind Multicenter Randomized Control Trial Comparing Intraperitoneal Nebulization and Peritoneal Instillation of Ropivacaine

STUDY OBJECTIVE To compare the effects of local anesthetic intraperitoneal nebulization with intraperitoneal instillation during laparoscopic ovarian cystectomy on postoperative morphine consumption and pain. DESIGN Multicenter, randomized, case-control trial. DESIGN CLASSIFICATION Canadian Task Force Classification I. SETTING University hospitals in Italy. PATIENTS One hundred forty patients scheduled for laparoscopic ovarian cystectomy. INTERVENTIONS Patients were randomized to receive either nebulization of ropivacaine 150 mg before surgery or instillation of ropivacaine 150 mg before surgery. Nebulization was performed using the Aeroneb Pro device (Aerogen, Galway, Ireland). MEASUREMENTS AND MAIN RESULTS One hundred forty patients were enrolled, and 123 completed the study. There was no difference between the 2 groups in average morphine consumption (7.3 ± 7.5 mg in the nebulization group vs 9.2 ± 7.2 mg in the instillation group; p = .17). Eighty-two percent of patients in the nebulization group required morphine compared with 96% in the instillation group (p < .05). Patients receiving nebulization had a lower dynamic Numeric Ranking Scale compared with those in the instillation group in the postanesthesia care unit postanesthesia care unit and 4 hours after surgery (p < .05). Ten patients (15%) in the nebulization group experienced shivering in the postanesthesia care unit compared with 2 patients (4%) in the instillation group (p = .035). CONCLUSION Nebulization of ropivacaine prevents the use of morphine in a significant proportion of patients, reduced postoperative pain during the first hours after surgery, and was associated with a higher incidence of postoperative shivering when compared with instillation.

Effects of Peritoneal Ropivacaine Nebulization for Pain Control After Laparoscopic Gynecologic Surgery

STUDY OBJECTIVE To evaluate the effects of peritoneal cold nebulization of ropivacaine on pain control after gynecologic laparoscopy. DESIGN Evidence obtained from a properly designed, randomized, double-blind, placebo-controlled trial (Canadian Task Force classification I). SETTING Tertiary care center. PATIENTS One hundred thirty-five women with American Society of Anesthesiologists disease classified as ASA I-III who were scheduled to undergo operative laparoscopy. INTERVENTION Patients were randomized to receive either nebulization of 30 mg ropivacaine before surgery (preoperative group), nebulization of 30 mg ropivacaine after surgery (postoperative group), instillation of 100 mg ropivacaine before surgery (instillation group), or instillation of saline solution (control group). Nebulization was performed using the Aeroneb Pro device. MEASUREMENT AND MAIN RESULTS Pain scores, morphine consumption, and ambulation time were collected in the post-anesthesia care unit and at 4, 6, and 24 hours postoperatively. One hundred eighteen patients completed the study. Patients in the preoperative group reported lower pain Numeric Ranking Scale values compared with those in the control group (net difference 2 points; 95% confidence interval [CI], 0.3-3.1 at 4 hours, 1-3 at 6 hours, and 0.7-3 at 24 hours; p = .01) Patients in the preoperative group consumed significantly less morphine than did those in the control group (net difference 7 mg; 95% CI, 0.7-13; p = .02). More patients who received nebulization walked without assistance within 12 hours after awakening than did those in the instillation and control groups (net difference 15%; 95% CI, 6%-24%; p = .001). CONCLUSIONS Cold nebulization of ropivacaine before surgery reduced postoperative pain and morphine consumption and was associated with earlier walking without assistance.

Peritoneal nebulization of ropivacaine during laparoscopic cholecystectomy: Dose finding and pharmacokinetic study

Background. Intraperitoneal nebulization of ropivacaine reduces postoperative pain and morphine consumption after laparoscopic surgery. The aim of this multicenter double-blind randomized controlled trial was to assess the efficacy of different doses and dose-related absorption of ropivacaine when nebulized in the peritoneal cavity during laparoscopic cholecystectomy. Methods. Patients were randomized to receive 50, 100, or 150 mg of ropivacaine 1% by peritoneal nebulization through a nebulizer. Morphine consumption, pain intensity in the abdomen, wound and shoulder, time to unassisted ambulation, discharge time, and adverse effects were collected during the first 48 hours after surgery. The pharmacokinetics of ropivacaine was evaluated using high performance liquid chromatography. Results. Nebulization of 50 mg of ropivacaine had the same effect of 100 or 150 mg in terms of postoperative morphine consumption, shoulder pain, postoperative nausea and vomiting, activity resumption, and hospital discharge timing (>0.05). Plasma concentrations did not reach toxic levels in any patient, and no significant differences were observed between groups (P > 0.05). Conclusions. There is no enhancement in analgesic efficacy with higher doses of nebulized ropivacaine during laparoscopic cholecystectomy. When administered with a microvibration-based aerosol humidification system, the pharmacokinetics of ropivacaine is constant and maintains an adequate safety profile for each dosage tested.

A Comparison of Differences Between the Systemic Pharmacokinetics of Levobupivacaine and Ropivacaine During Continuous Epidural Infusion: A Prospective, Randomized, Multicenter, Double-Blind Controlled Trial.

BACKGROUND:Epidural infusion of levobupivacaine and ropivacaine provides adequate postoperative pain management by minimizing side effects related to IV opioids and improving patient outcome. The safety profile of different drugs can be better estimated by comparing their pharmacokinetic profiles than by considering their objective side effects. Because levobupivacaine and ropivacaine have different pharmacokinetic properties, our aim was to investigate whether there is a difference in the pharmacokinetic variability of the 2 drugs in a homogeneous population undergoing continuous epidural infusion. This double-blind, multicenter, randomized, controlled trial study was designed to compare the pharmacokinetics of continuous thoracic epidural infusion of levobupivacaine 0.125% or ropivacaine 0.2% for postoperative pain management in adult patients who had undergone major abdominal, urological, or gynecological surgery. This study is focused on the evaluation of the coefficient of variation (CV) to assess the equivalence in the systemic exposure and interindividual variability between levobupivacaine and ropivacaine and, therefore, the possible differences in the predictability of the plasmatic concentrations of the 2 drugs during thoracic epidural infusion. METHODS:One hundred eighty-one adults undergoing major abdominal surgery were enrolled in the study. Patients were randomized to receive an epidural infusion of levobupivacaine 0.125% + sufentanil 0.75 &mgr;g/mL or of ropivacaine 0.2% + sufentanil 0.75 &mgr;g/mL at 5 mL/h for 48 hours. The primary end point of this study was to analyze the variability of plasma concentration of levobupivacaine and ropivacaine via an area under the curve within a range of 15% of the CV during 48 hours of continuous epidural infusion. The CV shows how the concentration values of local anesthetics are scattered around the median concentration value, thus indicating the extent to which plasma concentration is predictable during infusion. Secondary end points were to assess the pharmacologic profile of the local anesthetics used in the study, including an analysis of mean peak plasma concentrations, and also to assess plasma clearance, side effects, pain intensity (measured with a verbal numeric ranging score, i.e., static Numeric Rating Scale [NRS] and dynamic NRS]), and the need for rescue doses. RESULTS:The comparison between the 2 CVs showed no statistical difference: the difference between area under the curve was within the range of 15%. The CV was 0.54 for levobupivacaine and 0.51 for ropivacaine (P = 0.725). The plasma concentrations of ropivacaine approached the Cmax significantly faster than those of levobupivacaine. Clearance of ropivacaine decreases with increasing patient age. There were no significant differences in NRS, dynamic NRS scores, the number of rescue doses, or in side effects between groups. CONCLUSIONS:Considering the CV, the interindividual variability of plasma concentration for levobupivacaine and ropivacaine is equivalent after thoracic epidural infusion in adults. We found a reduction in clearance of ropivacaine depending on patient age, but this finding could be the result of some limitations of our study. The steady-state concentration was not reached during the 48-hour infusion and the behavior of plasma concentrations of ropivacaine and levobupivacaine during continuous infusions lasting more than 48 hours remains to be investigated, because they could reach toxic levels. Finally, no differences in the clinical efficacy or in the incidence of adverse effects between groups were found for either local anesthetic.

Negative Behaviour After Surgery

Early postoperative negative behaviour (e-PONB) and long-term negative behaviour changes affect young children after general anaesthesia. The aetiology and physiopathological mechanism are currently unclear. For clinicians, the more relevant components of e-PONB are pain, emergence delirium and emergence agitation. The recognition of the different aspects of e-PONB remains challenges, even for expert nurses and doctors. Several risk factors were described, but none clear indication for clinical practice is available due to the lack of consensus on definition, validated tools and gold standard management.