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

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.

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative; Anesthesia, Local; Opioid Use
• Intervention / Treatment: Drug: Placebo; Drug: Bupivacaine; Drug: Dexmedetomidine

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 Type: Interventional
• Enrollment (Anticipated): 540
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Staten Island, New York, United States, 10310
      • Richmond University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Wound infiltration with a placebo	Drug: Placebo; Injection of a placebo into the surgical wound
Experimental: Bupivacaine; Wound Infiltration with 20 mL (150mg) of 0.75% bupivacaine diluted with 5 mL of normal saline to give a 25 mL	Drug: Bupivacaine; Injection of bupivacaine into the surgical incision prior to its closure.; Other Names: Bupivacaine wound infiltration
Experimental: Bupivacaine and 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 .	Drug: Bupivacaine; Injection of bupivacaine into the surgical incision prior to its closure.; Other Names: Bupivacaine wound infiltration; Drug: Dexmedetomidine; Injection of dexmedetomidine ( an adjuvant) into the surgical incision prior to its closure.; Other Names: Dexmedetomidine wound infiltration

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Richmond University Medical Center
• Investigators: Principal Investigator: Nisha Lakhi, MD, Richmond University Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): September 17, 2018
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: March 22, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): June 4, 2018

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Pain management; dexmedetomidine; postoperative pain; bupivacaine; Wound infiltration; Post Cesarean
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Bupivacaine
• Other Study ID Numbers: Post Cesarean Pain Management

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes