Skip to main content
Clinical Trials/NCT02829944
NCT02829944
Completed
Phase 4

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

Duke University1 site in 1 country84 target enrollmentNovember 2016

Overview

Phase
Phase 4
Intervention
Ropivacaine
Conditions
Pain
Sponsor
Duke University
Enrollment
84
Locations
1
Primary Endpoint
Pain Score on Movement (Sitting in Bed From a Supine Position)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
September 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Ropivacaine

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.

Intervention: Ropivacaine

Ropivacaine

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.

Intervention: Ketorolac

Placebo

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.

Intervention: Placebo

Outcomes

Primary Outcomes

Pain Score on Movement (Sitting in Bed From a Supine Position)

Time Frame: 24 hours after surgery

Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable

Secondary Outcomes

  • Time to First Rescue Analgesic(48 hours)
  • Number of Subjects Experiencing Nausea(48 hours)
  • Patient Satisfaction With Postoperative Analgesia on a 0-10 Scale(48 hours)
  • Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale(6 months)
  • Pain Score on Movement(48 hours after surgery)
  • Pain Scores at Rest(48 hours)
  • Opioid Consumption(48 hours)
  • Number of Subjects Experiencing Pruritus(48 hours)
  • Number of Subjects Experiencing Vomiting(48 hours)
  • Number of Subjects With Chronic Pain(6 months)

Study Sites (1)

Loading locations...

Similar Trials