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

Phase 2

• Conditions: Pain, Postoperative; Opioid Use; Anesthesia, Local
• Interventions: Drug: Placebo; Drug: Bupivacaine; Drug: Dexmedetomidine

• Registration Number: NCT03545516
• Lead Sponsor: Richmond University Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2018-03-22
• Study First Submitted QC: 2018-05-22
• Study First Posted: 2018-06-04
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-29
• Study Start: 2018-09-17
• Primary Completion: 2018-11-01
• Study Completion: 2018-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 540

Inclusion Criteria

• All scheduled Cesarean deliveries with intrathecal or epidural anesthesia

Exclusion Criteria

• Emergency Cesarean deliveries
• Multifetal gestation
• Subjects <18 years old
• Subjects belonging to a vulnerable population (including subjects with a known opioid addiction, subjects with a history of mental illness and prisoners)
• Cesarean delivery with general anesthesia
• Known allergy or hypersensitivity to any of the study medications
• Subjects that can't comprehend the visual analog scale for quantitative pain assessment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Wound infiltration with a placebo
Bupivacaine	Bupivacaine	Wound Infiltration with 20 mL (150mg) of 0.75% bupivacaine diluted with 5 mL of normal saline to give a 25 mL
Bupivacaine and Dexmedetomidine	Bupivacaine	Wound Infiltration with 20 mL (150mg) of 0.75% bupivacaine and 1.5 mcg/kg of dexmedetomidine will be diluted with normal saline to make 25 mL of solution .
Bupivacaine and Dexmedetomidine	Dexmedetomidine	Wound Infiltration with 20 mL (150mg) of 0.75% bupivacaine and 1.5 mcg/kg of dexmedetomidine will be diluted with normal saline to make 25 mL of solution .

Primary Outcome Measures

Name	Time	Method
Total number of opioid free Cesarean deliveries	1 year	Measure the number of Cesarean deliveries that did not require opioid analgesia during the postoperative course

Secondary Outcome Measures

Name	Time	Method
Complications from procedures	0-14 days	Measure any complications associated with the wound infiltration procedure
Side effects/Adverse reactions	0-14 days	Measure any side effects/allergic reactions attributed to use of any of the study drugs.
Breast feeding capacity	0-14 days	Assess the subject's capacity to breast feed during the postoperative course
Time to first rescue analgesia	0 hour post-cesarean to time rescue analgeisa is administered]	Measure the time to first rescue analgesia from immediate post operative (0 hour) till when the rescue analgesia is administered
Postoperative hospital stay	0-14days	Measure the length of the post-operative hospital stay .
Total opioid consumption	0-14 days	Measure the subjects total opioid consumption for the total duration of the postoperative course.

Trial Locations

Locations (1)

Richmond University Medical Center; 🇺🇸 Staten Island, New York, United States