Regina Maria Renner

Pain control in first-trimester surgical abortion: a systematic review of randomized controlled trials

BACKGROUND First-trimester abortions especially cervical dilation and suction aspiration are associated with pain despite various methods of pain control. STUDY DESIGN Following the guidelines for a Cochrane review, we systematically searched for and reviewed randomized controlled trials comparing methods of pain control in first-trimester surgical abortion at less than 14 weeks gestational age using electric or manual suction aspiration. Outcomes included intra- and postoperative pain, side effects, recovery measures and satisfaction. RESULTS We included 40 trials with 5131 participants. Because of heterogeneity, we divided studies into seven groups: Local anesthesia: Data were insufficient to show a clear benefit of a paracervical block (PCB) compared to no PCB. Reported mean pain scores (10-point scale) during dilation and aspiration were improved with carbonated lidocaine [weighted mean difference (WMD), -0.80; 95% confidence interval (CI), -0.89 to -0.71; WMD, -0.96; 95% CI, -1.67 to -0.25], deep injection (WMD, -1.64; 95% CI, -3.21 to -0.08; WMD, 1.00; 95% CI, 1.09 to 0.91), and with adding a 4% intrauterine lidocaine infusion (WMD, -2.0; 95% CI, -3.29 to -0.71; WMD, -2.8; 95% CI, -3.95 to -1.65). PCB with premedication: Ibuprofen and naproxen resulted in small reduction of intra- and postoperative pain. Conscious sedation: The addition of conscious intravenous sedation using diazepam and fentanyl to PCB decreased procedural pain. General anesthesia: Conscious sedation increased intraoperative but decreased postoperative pain compared to general anesthesia (GA) [Peto odds ratio (Peto OR) 14.77 (95%, CI 4.91-44.38) and Peto OR 7.47 (95% CI, 2.2-25.36) for dilation and aspiration, respectively, and WMD -1.00 (95% CI, -1.77 to -0.23) postoperatively). Inhalation anesthetics are associated with increased blood loss (p<0.001). GA with premedication: The cyclooxygenase (COX)-2 inhibitor etoricoxib; the nonselective COX inhibitors lornoxicam, diclofenac and ketorolac IM; and the opioid nalbuphine improved postoperative pain. Nonpharmacological intervention: Listening to music decreased procedural pain. No major complication was observed. CONCLUSIONS Conscious sedation, GA and some nonpharmacological interventions decreased procedural and postoperative pain, while being safe and satisfactory to patients. Data on the widely used PCB are inadequate to support its use, and it needs to be further studied to determine any benefit.

Paracervical Block for Pain Control in First-trimester Surgical Abortion: A Randomized Controlled Trial

OBJECTIVE: Despite lack of efficacy data, the majority of first-trimester surgical abortions are performed with a paracervical block. Women may be unnecessarily exposed to a painful injection and potentially noxious medication. Our objective was to estimate the effect of a paracervical block and the effect of gestational age on patient pain perception. METHODS: This was a randomized, single-blind trial of patients undergoing abortion receiving paracervical block or sham stratified by gestational age (early: less than 8 weeks of gestation, n=60; late: 8–10 6/7 weeks of gestation, n=60). Premedicated with ibuprofen and lorazepam, all participants received 2 mL 1% buffered lidocaine injected at the tenaculum site followed by a slow, deep injection of 18 mL at four sites (block) or no injection (sham) with a 3-minute wait. The primary outcome was dilation pain (100-mm visual analog scale). Secondary outcomes included pain at additional time points, satisfaction, need for more analgesics, and adverse events. RESULTS: Full enrollment occurred (n=120). We used intent-to-treat analysis. Demographics did not differ between groups. Paracervical block administration was painful (mean 55 mm compared with sham 30 mm, P<.001) but decreased dilation pain (42 mm compared with 79 mm, P<.001) and aspiration pain (63mm compared with 89 mm, P<.001). These results were consistent for both gestational age strata; however, paracervical block benefit was greater at an earlier gestation. Satisfaction scores with pain control and the procedure were significantly higher in the block group. CONCLUSION: Although paracervical block is painful, it reduces first-trimester abortion pain regardless of gestational age, but the benefit on dilation pain was greater at earlier gestations. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01094366. LEVEL OF EVIDENCE: I

Unexpectedly increased rate of surgical site infections following implant surgery for hip fractures: Problem solution with the bundle approach

INTRODUCTION Surgical site infections (SSIs) are the most common nosocomial infections after surgery.However, clinical guidance on how to handle any suspicious clusters of SSI in orthopaedic surgery is missing. We report on problem analysis and solution finding following the observation of an increased rate of SSI in trauma implant surgery. SETTING Trauma unit of a university hospital. METHODS Over a 2-year observation period, all patients (n = 370) following surgical stabilisation of proximal femur fractures in a trauma unit of a university hospital were consecutively followed using a standardised case report form. First, a retrospective cohort of 217 patients was collected for whom an increased SSI rate was detected. Based on risk analysis, new standard perioperative procedures were developed and implemented. The impact was evaluated in a prospective cohort of 153 comparable patients. Uni- and multivariable analysis of factors associated with the risk for SSI was undertaken. RESULTS The intervention bundle resulted in a significant reduction of an initially increased SSI incidence of 6.9 (down) to 2.0% (p = 0.029). Multivariable analysis revealed four risk factors significantly associated with a higher risk of SSI caused by different bacteria: duration of surgery (p = 0.002), hemiarthroplasty(p = 0.002), haematoma (p = 0.004) and the presence of two operating room staff members (p < 0.001 and 0.035). CONCLUSIONS A standardised prospective SSI protocol and detection system offering the simultaneous use of data should guarantee every institution immediate alarm registration to avoid comparable problem situations. Detailed interdisciplinary analysis followed by the implementation of coherent interventions, based on a best-evidence structured bundle approach, may adequately resolve similar critical incidence episodes.

Hydrocodone-acetaminophen for pain control in first-trimester surgical abortion: a randomized controlled trial.

OBJECTIVE: Although hydrocodone–acetaminophen is commonly used for pain control in first-trimester abortion, the efficacy of oral opioids for decreasing pain has not been established. Our objective was to estimate the effect of hydrocodone–acetaminophen on patient pain perception during first-trimester surgical abortion. METHODS: We conducted a randomized, double-blinded, placebo-controlled trial. Patients (before 11 weeks of gestation) received standard premedication (ibuprofen and lorazepam) and a paracervical block with the addition of 10 mg hydrocodone and 650 mg acetaminophen or placebo 45–90 minutes before surgical abortion. A sample size of 120 was calculated to provide 80% power to show a 15-mm difference (&agr;=0.05) in the primary outcome of pain with uterine aspiration (100-mm visual analog scale). Secondary outcomes were pain at additional time points, satisfaction, side effects, adverse events, and need for additional pain medications. RESULTS: There were no significant differences in demographics or baseline pain between groups. There were no differences in pain scores between patients receiving hydrocodone–acetaminophen compared with placebo during uterine aspiration (65.7 mm compared with 63.2 mm, P=.59) or other procedural time points. There were no differences in satisfaction or need for additional pain medications. Patients who received hydrocodone–acetaminophen had more postoperative nausea than those receiving placebo (P=.03) when controlling for baseline nausea. No medication-related adverse events were noted. CONCLUSION: Hydrocodone–acetaminophen does not decrease pain during first-trimester abortion and may increase postoperative nausea. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT01330459. LEVEL OF EVIDENCE: I

Refining paracervical block techniques for pain control in first trimester surgical abortion: a randomized controlled noninferiority trial

OBJECTIVES Our objective was to evaluate two different aspects of the paracervical block (PCB) technique for first trimester surgical abortion, to compare a 3-min wait prior to cervical dilation to no wait and to compare four-site with two-site injection. STUDY DESIGN We conducted two consecutive randomized, single-blinded noninferiority trials. In the first trial, women <11 weeks gestational age received a 20-mL 1% buffered lidocaine four-site PCB with either a 3-min wait between PCB injection and dilation or no wait. In the second trial, we compared a four-site with a two-site PCB. We evaluated dilation pain [100-mm visual analogue scale (VAS)] as the primary outcome. Secondary outcomes included pain at additional time points, anxiety, satisfaction and adverse events. RESULTS Both trials fully enrolled (total n=332). Results were inconclusive as to whether no wait was noninferior to waiting 3-min prior to cervical dilation for dilation pain [VAS: 63 mm (SD, 24 mm) vs. 56 mm (SD, 32mm)] and as to whether a two-site PCB was noninferior to a four-site block [VAS: 68 mm (SD, 21 mm) vs. 60 mm (SD, 30 mm)]. Noninferiority analysis was inconclusive because the confidence interval of the mean pain score difference between groups included the predefined inferiority margin of 13-mm pain difference. Superiority analysis showed the four-site PCB to be superior to the two-site PCB. CONCLUSION It remained inconclusive whether a 3-min wait time between PCB and cervical dilation provides noninferior pain control for first trimester surgical abortion. However, a four-site PCB appeared to be superior to a two-site PCB. IMPLICATIONS It remained inconclusive whether a 3-min wait time between PCB and cervical dilation or using a two-site instead of a four-site PCB provided noninferior pain control for first trimester surgical abortion. This study did not assess whether the combination of the two separate factors provides additive benefit.