A randomized controlled trial of liposomal bupivacaine for pain following obstetrical laceration.

BACKGROUND: Postpartum pain management is critical after vaginal delivery involving a second, third, or fourth degree laceration as patients heal from their repair. Uncontrolled postpartum pain can affect both the physical and mental recovery period, extend hospital stays, and increase the potential for serious adverse reactions with pain medications. In light of the opioid crisis and increase in dependency after utilization, finding alternatives for pain management after procedures is paramount. The need for a safe, effective, long-acting medication to treat postpartum and postoperative pain has reached a critical point in the current healthcare climate. OBJECTIVE: To minimize pain after vaginal delivery, we assessed the effectiveness of liposomal bupivacaine vs plain bupivacaine injected into the perineum after second, third, or fourth degree lacerations. We hypothesized that the liposomal bupivacaine study group would have less vaginal pain, analgesic usage, and improved quality of life compared with the plain bupivacaine control group. MATERIALS AND METHODS: This is a single-blinded randomized controlled trial with 120 subjects enrolled at Walter Reed National Military Medical Center, Bethesda, Maryland, from February 2018 to February 2019. After vaginal delivery and repair, study participants were randomized into 20-mL liposomal bupivacaine (study group) or 20-mL 0.25% plain bupivacaine (control group) injected into and around the perineal body bilaterally. On postpartum days 1, 3, and 7, pain scores and analgesics were recorded. Our primary outcome was vaginal pain score at postpartum day 3, analyzed with Wilcoxon rank-sum test. Our secondary outcomes included vaginal pain at postpartum days 1 and 7, pain with bowel movement, sleep disturbance, and pain's impact on activity, stress, and mood. Desired statistical power was achieved with 48 patients per group (total of 96 patients). RESULTS: A total of 60 patients were randomized to each group; 108 patients completed the study. Most patients (94%) had regional anesthesia. There was no statistically significant difference in the demographics between these groups. There were 25 obstetric anal sphincter injuries, equally distributed between the 2 groups (P>.99). There was no significant difference between vaginal pain scores at postpartum day 3 (control, 2 [1-3]; study, 2 [0-3]) (P=.63). This was also seen at postpartum day 1 (control, 2 [0-3]; study, 2 [0-3]) (P=.82) and postpartum day 7 (control, 1 [0-3]; study, 1 [0-2]) (P=.47). Cumulative pain scores for postpartum days 1, 3, and 7 failed to reach significance (study, 5 [3-8]; control, 6 [3-8]) (P=.83). Secondary analysis of pain with bowel movement and impact on sleep, activity, stress, and mood found no differences. Given that only 3 patients required outpatient opioids, there were insufficient data to calculate morphine equivalent differences. CONCLUSION: After obstetric lacerations, there is no proven benefit to lateral and intraperineal injection of liposomal bupivacaine over plain bupivacaine in postpartum vaginal pain scores, quality of life scores, or pain medication utilized. This may be due to low pain scores and opioid usage, both groups benefiting from the intervention, or ineffective perineal injection location.

What is the accuracy of an early third trimester sonogram for identifying LGA infants born to GDM patients diagnosed with the one-step approach?

PURPOSE: The one-step approach for screening of GDM will increase the incidence 2- to 3-fold. These larger cohorts may need to target high-morbidity subsets to be cost-effective. We asked whether ultrasound could stratify the GDM patients with the highest risk for a large for gestational age (LGA) infant. MATERIALS AND METHODS: A retrospective analysis was performed on 413 GDM patients diagnosed using the one-step approach. Ultrasound data from 28 weeks 0 day to 34 weeks 6 days was studied. The abdominal circumference (AC) and EFW at thresholds between 70 and 95% were examined for their prognostic utility. The primary outcome was an LGA infant. RESULTS: Both the AC and EFW at all gestational ages were predictive of a LGA infant. The AC and EFW at 28-32 weeks 6 days using a threshold of ≥70% showed the following test characteristics: sensitivity (73 versus 66%), specificity (61 versus 77%), positive predictive value (PPV) (30 versus 40%), and negative predictive value (NPV) (91 versus 91%). The specificity of the EFW was significantly higher than the AC (p < .001). CONCLUSION: Among GDM patients diagnosed using the one-step approach, an elevated AC and EFW in the early third trimester are predictive of a LGA infant. This is a possible cost-effective way to stratify the one-step GDM pregnancies at highest risk for neonatal morbidity.