Dataset Information

A Randomized Trial Comparing Skin Antiseptic Agents at Cesarean Delivery.

ABSTRACT:

Background

Preoperative skin antisepsis has the potential to decrease the risk of surgical-site infection. However, evidence is limited to guide the choice of antiseptic agent at cesarean delivery, which is the most common major surgical procedure among women in the United States.

Methods

In this single-center, randomized, controlled trial, we evaluated whether the use of chlorhexidine-alcohol for preoperative skin antisepsis was superior to the use of iodine-alcohol for the prevention of surgical-site infection after cesarean delivery. We randomly assigned patients undergoing cesarean delivery to skin preparation with either chlorhexidine-alcohol or iodine-alcohol. The primary outcome was superficial or deep surgical-site infection within 30 days after cesarean delivery, on the basis of definitions from the Centers for Disease Control and Prevention.

Results

From September 2011 through June 2015, a total of 1147 patients were enrolled; 572 patients were assigned to chlorhexidine-alcohol and 575 to iodine-alcohol. In an intention-to-treat analysis, surgical-site infection was diagnosed in 23 patients (4.0%) in the chlorhexidine-alcohol group and in 42 (7.3%) in the iodine-alcohol group (relative risk, 0.55; 95% confidence interval, 0.34 to 0.90; P=0.02). The rate of superficial surgical-site infection was 3.0% in the chlorhexidine-alcohol group and 4.9% in the iodine-alcohol group (P=0.10); the rate of deep infection was 1.0% and 2.4%, respectively (P=0.07). The frequency of adverse skin reactions was similar in the two groups.

Conclusions

The use of chlorhexidine-alcohol for preoperative skin antisepsis resulted in a significantly lower risk of surgical-site infection after cesarean delivery than did the use of iodine-alcohol. (Funded by the National Institutes of Health and Washington University School of Medicine in St. Louis; ClinicalTrials.gov number, NCT01472549.).

SUBMITTER: Tuuli MG

PROVIDER: S-EPMC4777327 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature

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A Randomized Trial Comparing Skin Antiseptic Agents at Cesarean Delivery.

Tuuli Methodius G MG Liu Jingxia J Stout Molly J MJ Martin Shannon S Cahill Alison G AG Odibo Anthony O AO Colditz Graham A GA Macones George A GA

The New England journal of medicine 20160204 7

<h4>Background</h4>Preoperative skin antisepsis has the potential to decrease the risk of surgical-site infection. However, evidence is limited to guide the choice of antiseptic agent at cesarean delivery, which is the most common major surgical procedure among women in the United States.<h4>Methods</h4>In this single-center, randomized, controlled trial, we evaluated whether the use of chlorhexidine-alcohol for preoperative skin antisepsis was superior to the use of iodine-alcohol for the preve ...[more]

PMID: 26844840

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Project description:Improved pain control after cesarean delivery remains a challenging objective. Poorly treated acute pain following delivery is associated with an increased risk of chronic pain and depression. This study was conducted to determine whether the addition of systemic acetaminophen and an increased dose of intrathecal morphine would further reduce acute pain. The primary outcome was pain intensity with movement at 24 hours postoperatively. Secondary measures included persistent pain and depression at 8 weeks.Seventy-four parturients scheduled for elective cesarean delivery under spinal anesthesia that were predicted to be above the 80th percentile for evoked pain intensity based on a 3-item preoperative screening questionnaire were enrolled. Patients in the intervention group received 300 mcg spinal morphine and 1 gram acetaminophen every 6 hours for 24 hours postoperatively. Patients in the control group received 150 mcg spinal morphine and placebo tablets. All patients received scheduled ibuprofen by mouth and IV morphine patient-controlled analgesia. At 24 hours, patients rated their pain intensity with movement, at rest, on average, and worst score using a visual analog scale for pain (100-mm unmarked line). The presence of persistent pain and depression was assessed at 8 weeks using the Edinburgh postpartum depression survey.Providing a higher dose of spinal morphine combined with systemic acetaminophen to patients predicted to be at high risk for severe post-cesarean delivery pain significantly reduced evoked pain scores with movement at 24 hours (mean ± SD: 46 ± 25 mm in control group versus 31 ±17 mm in intervention group, P = 0.009; 95% confidence interval for the difference between means: 4 mm, 26 mm). There was no difference in the incidence of persistent pain (13% (4/30) in control group versus 10% (3/30) in intervention group, P > 0.99), or depression at 8 weeks postoperatively (10% (3/30) in control group versus 13% (4/30) in intervention group, P > 0.99).Adding a higher dose of intrathecal morphine and oral acetaminophen to a multimodal pain regimen in patients predicted to be at risk for high acute postpartum pain after cesarean delivery results in a significant reduction of acute postoperative pain scores at 24 hours.

Project description:IntroductionPercutaneous auricular nerve stimulation has been used for the treatment of symptoms associated with opioid withdrawal, including abdominal pain, nausea, and general discomfort. However, its potential utility for pain management and opioid minimization after surgery has not been investigated. The purpose of this study was to test the feasibility and acceptability of a trial protocol designed to assess the effectiveness of the NSS2-Bridge device as a non-pharmacologic alternative to opioids after cesarean delivery.MethodsIn a randomized control design, healthy women receiving cesarean delivery were randomized to receive the active device, placebo device, or no device. Devices were placed on the ear following cesarean delivery and left in place for 5 days. Feasibility and acceptability of the device was assessed by patient reports of device tolerability (rated on a 100mm visual analog scale where 0 is not tolerable at all and 100 is the most tolerable) as well as qualitative reporting. Additional outcomes assessed included proportion of patients not using opioids in hospital, as well as pain at rest, pain with movement, and total opioid consumption in the hospital and for the first 5 days after surgery.ResultsThere were 60 patients included in the final analysis. Device tolerability was rated highly, with an average daily score of >75 mm on the visual analog scale. The trial retention rate was 89.7% with most exclusions (42.9%) occurring due to unanticipated development of care complexity (e.g., hemorrhage and additional surgical procedures), with only 1 exclusion (14.3%) due to device discomfort. The active device group achieved the highest proportion of opioid-free hospitalizations (40%) compared to placebo (20%) and no device groups (30%). Pain at rest and with movement was similar between treatment groups.ConclusionsThis trial protocol designed to test the efficacy of NSS2-Bridge device for post-cesarean pain management is feasible and acceptable. Larger proportions of patients not using opioids in the active device group justifies additional investigation on device effectiveness in pregnant and postpartum people at highest risk for pain.

Project description:Objective Rectus muscle reapproximation at cesarean delivery (CD) is performed frequently by some obstetricians; however, the effect on postoperative pain is unclear. To this end, we investigated whether rectus muscle reapproximation increases postoperative pain. Materials and Methods This is a prospective, double-blind, randomized controlled trial of women undergoing primary CD with singleton or twin pregnancy at >35 weeks' gestation. Women were randomized to rectus muscle reapproximation with three interrupted sutures or no reapproximation. Exclusion criteria were prior cesarean, prior laparotomy, vertical skin incision, active labor, chronic analgesia use, allergy to opioid or nonsteroidal anti-inflammatory drugs, and body mass index ≥ 40. Intra- and postoperative pain management was standardized within the study protocol. The primary outcome was a combined movement pain and opioid use score averaged over the 72-hour study period, called the Silverman integrated assessment. Movement pain scores were assessed at 24, 48, and 72 postoperative hours. Results In total, 63 women were randomized, of whom 35 underwent rectus muscle reapproximation and 28 did not. Demographic and obstetric variables were similar between groups. Silverman integrated assessment scores during the 72-hour postoperative period were higher in the rectus muscle reapproximation group (15 ± 100% vs. -31 ± 78% difference from the mean; p = 0.04). Operative times were similar between groups (63 ± 15 vs. 65 ± 15 minutes; p = 0.61), and there were no surgical complications in either group. Maternal satisfaction with analgesia at 72 hours was high in both groups (85% [73-90] rectus muscle reapproximation vs. 90% [75-100]; p = 0.16). Conclusion Rectus muscle reapproximation increased immediate postoperative pain without differences in operative time, surgical complications, or maternal satisfaction. Benefits of rectus muscle reapproximation should be weighed against increased postoperative pain, and analgesia should be planned accordingly.

Project description:ImportanceA pharmacological approach to pain control after cesarean delivery is often insufficient on its own. Acupuncture is a promising method for mitigating postoperative pain and reducing postoperative opioid requirements.ObjectiveTo evaluate the efficacy and effectiveness of acupuncture as an adjunctive therapy for pain control after cesarean delivery, compared with a placebo intervention and standard care alone.Design, setting, and participantsThis single-center, placebo-controlled, patient- and assessor-blinded randomized clinical trial was conducted from January 13, 2015, to June 27, 2018, at a tertiary university hospital in Greifswald, Germany. Participants were women who were scheduled for elective cesarean delivery under spinal anesthesia and were randomized to either the acupuncture group (n = 60) or placebo group (n = 60). Another 60 consecutive patients who met the eligibility criteria and received the standard postoperative analgesia were selected to form a nonrandomized standard care group. The intention-to-treat analysis was performed from August 19, 2019, to September 13, 2019.InterventionsIn addition to standard pain treatment, each patient in the acupuncture group received auricular and body acupuncture with indwelling intradermal needles, whereas patients in the placebo group were treated with nonpenetrating placebo needles.Main outcomes and measuresThe primary outcome was pain intensity on movement, which was measured using an 11-item verbal rating scale. Secondary outcomes were analgesia-related adverse effects, analgesics consumption, time to mobilization and Foley catheter removal, quality of patient blinding to randomization, and patient satisfaction with treatment of pain.ResultsA total of 180 female patients (mean [SD] age, 31 [5] years) were included in the intention-to-treat analysis. The mean pain intensity on movement in the acupuncture group on the first postoperative day was lower than in the placebo group (4.7 [1.8] vs 6.0 [2.0] points; Cohen d, 0.73; 95% CI, 0.31-1.01; P = .001) and the standard care group (6.3 [1.3] points; Cohen d, 1.01; 95% CI, 0.63-1.40; P < .001). On the first postoperative day, 59 patients (98%) in the acupuncture group were fully mobilized vs 49 patients (83%) in the placebo group (relative risk [RR], 1.18; 95% CI, 1.06-1.33; P = .01) and 35 patients (58%) in the standard care group (RR, 1.69; 95% CI, 1.36-2.09; P < .001). The Foley catheter was removed in a total of 57 patients (93%) from the acupuncture group vs 43 patients (72%) from the placebo group (RR, 1.33; 95% CI, 1.12-1.57; P = .003) and 42 patients (70%) from the standard care group (RR, 1.37; 95% CI, 1.14-1.62; P = .002). Other parameters were comparable across the 3 study groups.Conclusions and relevanceResults of this trial showed that acupuncture was safe and effective in reducing pain and accelerating mobilization of patients after cesarean delivery. With consideration for personnel and time expenditures, acupuncture can be recommended as routine, supplemental therapy for pain control in patients after elective cesarean delivery.Trial registrationClinicalTrials.gov Identifier: NCT02364167.

Dataset Information

A Randomized Trial Comparing Skin Antiseptic Agents at Cesarean Delivery.

Background

Methods

Results

Conclusions

Publications

A Randomized Trial Comparing Skin Antiseptic Agents at Cesarean Delivery.

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