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

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Placebo; Drug: Ropivacaine; Drug: Ketorolac

• Registration Number: NCT02829944
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-08
• Study First Submitted QC: 2016-07-08
• Study First Posted: 2016-07-12
• Study Start: 2016-11
• Primary Completion: 2019-03
• Study Completion: 2019-09
• Status Verified: 2020-02
• Results First Submitted: 2020-02-21
• Results First Submitted QC: 2020-02-21
• Last Update Submitted: 2020-02-21
• Results First Posted: 2020-03-06
• Last Update Posted: 2020-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
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.
Ropivacaine	Ketorolac	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.

Primary Outcome Measures

Name	Time	Method
Pain Score on Movement (Sitting in Bed From a Supine Position)	24 hours after surgery	Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Experiencing Nausea	48 hours	Asking patients whether or not they experienced the symptom in the preceding time-frame
Patient Satisfaction With Postoperative Analgesia on a 0-10 Scale	48 hours	Score reported on a scale of 0-10, with 0 being not at all satisfied and 10 being completely satisfied
Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale	6 months	Patients contacted over the phone completed screening with the EPDS, on a scale of 0-30. A score of over 13 indicate risk for postpartum depression
Pain Score on Movement	48 hours after surgery	Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Pain Scores at Rest	48 hours	Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Opioid Consumption	48 hours	measured in mg oxycodone equivalents
Number of Subjects Experiencing Pruritus	48 hours	Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Number of Subjects Experiencing Vomiting	48 hours	Asking patients whether or not they experienced the symptom in the preceding time-frame
Number of Subjects With Chronic Pain	6 months	Phone interview asking patient about presence of pain at incision site
Time to First Rescue Analgesic	48 hours

Trial Locations

Locations (1)

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States