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

Richmond University Medical Center

Status and phase: Unknown; Phase 2

Conditions: Anesthesia, Local; Pain, Postoperative; Opioid Use

Treatments: Drug: Placebo; Drug: Dexmedetomidine; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03545516

Post Cesarean Pain Management

Details and patient eligibility

About

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.

Full 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.

Enrollment: 540 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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540 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Wound infiltration with a placebo

Treatment:

Drug: Placebo

Bupivacaine

Experimental group

Description:

Wound Infiltration with 20 mL (150mg) of 0.75% bupivacaine diluted with 5 mL of normal saline to give a 25 mL

Treatment:

Drug: Bupivacaine

Bupivacaine and Dexmedetomidine

Experimental group

Description:

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 .

Treatment:

Drug: Bupivacaine

Drug: Dexmedetomidine