NCT04232306

Liposomal Bupivacaine + Bupivacaine vs. Bupivacaine Alone on Opioid Use After Elective c/Section

The Effect of Liposomal Bupivacaine Plus Bupivacaine Versus Bupivacaine Alone on Postoperative Opioid Use After Elective Cesarean Delivery: a Randomized Control Trial

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the effectiveness of local wound infiltration of EXPAREL® (liposomal bupivacaine) with bupivacaine HCl compared to active control with bupivacaine HCl alone following elective primary or repeat cesarean delivery with spinal anesthesia.

Detailed description

Pain in the postpartum period is an important concern of new mothers. With over one-third of deliveries ending in cesarean section, effective postoperative pain control is essential in the care of postpartum patients.1 Improved pain control in the postpartum period after cesarean delivery (CD) is associated with improved overall maternal health and satisfaction, decreased postpartum depression, shortened hospital stay, decreased opioid consumption, and decreased healthcare costs, as well as possible facilitation of early contact of mothers with their infants.2 Pain control is of great concern to women during and after cesarean delivery.3 Pain relief and patient satisfaction are inadequate in many cases. Pain may be severe, last at least 48-72 hours, and may impair early postoperative recovery. Opioids are primarily used in the post-operative period. Although opioids are safe to use in breastfeeding mothers, they are not without unwanted side effects.4 Local anesthetics and parenteral NSAIDs are also beneficial adjuncts to regional or general anesthesia after CD by reducing opioid consumption and improving pain relief.5 In addition, field block with wound infiltration with local anesthetic is an effective and safe adjunct for pain control. Previous studies have shown improved postoperative pain control with TAP (transversus abdominis plane) blocks with bupivacaine in hysterectomy patients.4 Another study has looked at the effects of bupivacaine-soaked spongostan placed in cesarean wounds.2 EXPAREL®® (Parsippany, NJ: Pacira Pharmaceuticals, Inc) is a liposomal form of bupivacaine. Its mechanism of action is by DepoFoam® technology, in which microscopic, polyhedral molecules that contain aqueous chambers with liposomal bupivacaine that are slowly released over hours to days with erosion and rearrangement of lipid membranes.6 The slow release of local anesthetic extends its pharmacologic effect and provides longer postsurgical pain control for up to 72 hours.6 This method of delivery of local anesthetic has the potential to decrease postoperative opioid consumption.7 EXPAREL® is an FDA-approved medication for the general use of postoperative surgical site pain control. Paracervical block is the only obstetric contraindication to EXPAREL® use. The purpose of this study is to compare the effectiveness of local wound infiltration of EXPAREL® (liposomal bupivacaine) with bupivacaine HCl compared to active control with bupivacaine HCl alone following elective primary or repeat cesarean delivery with spinal anesthesia. The investigators hypothesize that narcotic use during postoperative hospitalization will be decreased using liposomal bupivacaine.

Conditions

• Postoperative Pain
• Cesarean Section

Interventions

Type	Name	Description
DRUG	Liposomal bupivacaine	Bupivacaine liposome injectable suspension
DRUG	Bupivacaine HCl	Bupivacaine HCl surgical-site incision infiltration

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2020-01-18
• Last updated: 2024-04-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study