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

Richmond University Medical Center540 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

540

Conditions

Pain, Postoperative Anesthesia, Local Opioid Use

Interventions

BupivacaineDRUG

Injection of bupivacaine into the surgical incision prior to its closure.

DexmedetomidineDRUG

Injection of dexmedetomidine ( an adjuvant) into the surgical incision prior to its closure.

PlaceboDRUG

Injection of a placebo into the surgical wound

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Richmond University Medical Center

Staten Island, New York, United States

Outcomes

Primary Outcomes

Total number of opioid free Cesarean deliveries

Measure the number of Cesarean deliveries that did not require opioid analgesia during the postoperative course

Time frame: 1 year

Secondary Outcomes

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

Time frame: 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.

Time frame: 0-14 days

Side effects/Adverse reactions

Measure any side effects/allergic reactions attributed to use of any of the study drugs.

Time frame: 0-14 days

Postoperative hospital stay

Measure the length of the post-operative hospital stay .

Time frame: 0-14days

Complications from procedures

Measure any complications associated with the wound infiltration procedure

Time frame: 0-14 days

Breast feeding capacity

Assess the subject's capacity to breast feed during the postoperative course

Time frame: 0-14 days

Central Contacts

Nisha Lakhi, MD

CONTACT

718-818-2109 NLAKHI@RUMCSI.org

Data from ClinicalTrials.gov

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