Impact of Local Anesthetic Wound Infiltration on Postoperative Pain Following Cesarean Delivery

Duke University

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Ropivacaine; Drug: Ketorolac; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02829944

Pro00069752

Details and patient eligibility

About

The purpose of this study is to determine if the infusion of the local anesthetic ropivacaine (a numbing medicine) and the non-steroidal anti-inflammatory drug ketorolac (a pain killer similar to ibuprofen) through a catheter placed along the cesarean delivery incision, will reduce the pain experienced after cesarean section and need for narcotic pain medicine.

Enrollment: 84 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiology (ASA) class 1,2, and 3
• English speaking women at a gestational age > 37 weeks
• scheduled for cesarean delivery under spinal or combined spinal epidural anesthesia

Exclusion criteria

• BMI > 50 kg/m2
• history of intravenous drug or opioid abuse
• previous history of chronic pain syndrome
• history of opioid use in the past week
• allergy or contraindication to any of the study medications
• non-English speaking

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups, including a placebo group

Ropivacaine

Experimental group

Description:

Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.

Treatment:

Drug: Ropivacaine

Drug: Ketorolac

Placebo

Placebo Comparator group

Description:

Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.

Treatment:

Drug: Placebo