NCT03545516

Wound Infiltration as Part of an Opioid Free Pain Management Pathway Following Cesarean Delivery

Randomized Control Trial for an Opioid Free Analgesic Pathway Post Cesarean Delivery

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: Richmond University Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will investigate the effect of three types of wound infiltration on post Cesarean opioid analgesia consumption when used in conjunction with an opioid free postoperative analgesia pathway.

Detailed description

The subjects that meet the inclusion criteria of the study will be randomized preoperatively into three arms following a 1:1:1 ratio. During the intraoperative course one of three combinations of wound infiltration will be administered to subjects prior to the closure of the surgical incision. Subjects in Group I will receive a placebo of normal saline. Subjects in Group II will receive bupivacaine alone. Subjects in Group III will receive both bupivacaine and dexmedetomidine.

Conditions

• Pain, Postoperative
• Anesthesia, Local
• Opioid Use

Interventions

Type	Name	Description
DRUG	Bupivacaine	Injection of bupivacaine into the surgical incision prior to its closure.
DRUG	Dexmedetomidine	Injection of dexmedetomidine ( an adjuvant) into the surgical incision prior to its closure.
DRUG	Placebo	Injection of a placebo into the surgical wound

Timeline

• Start date: 2018-09-17
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2018-06-04
• Last updated: 2018-08-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study