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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Placebo; Drug: Ropivacaine; Drug: Ketorolac

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Ropivacaine; Drug: Ketorolac
Placebo Comparator: 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.	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores at Rest	Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable	2 hours
Pain Scores at Rest	Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable	24 hours
Pain Scores at Rest	Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable	48 hours
Opioid Consumption	measured in mg oxycodone equivalents	2 hours
Opioid Consumption	measured in mg oxycodone equivalents	24 hours
Opioid Consumption	measured in mg oxycodone equivalents	48 hours
Time to First Rescue Analgesic		48 hours
Number of Subjects Experiencing Nausea	Asking patients whether or not they experienced the symptom in the preceding time-frame	2 hours
Number of Subjects Experiencing Nausea	Asking patients whether or not they experienced the symptom in the preceding time-frame	24 hours
Number of Subjects Experiencing Nausea	Asking patients whether or not they experienced the symptom in the preceding time-frame	48 hours
Number of Subjects Experiencing Vomiting	Asking patients whether or not they experienced the symptom in the preceding time-frame	2 hours
Number of Subjects Experiencing Vomiting	Asking patients whether or not they experienced the symptom in the preceding time-frame	24 hours
Number of Subjects Experiencing Vomiting	Asking patients whether or not they experienced the symptom in the preceding time-frame	48 hours
Number of Subjects Experiencing Pruritus	Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable	2 hours
Number of Subjects Experiencing Pruritus	Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable	24 hours
Number of Subjects Experiencing Pruritus	Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable	48 hours
Patient Satisfaction With Postoperative Analgesia on a 0-10 Scale	Score reported on a scale of 0-10, with 0 being not at all satisfied and 10 being completely satisfied	48 hours
Number of Subjects With Chronic Pain	Phone interview asking patient about presence of pain at incision site	8 weeks
Number of Subjects With Chronic Pain	Phone interview asking patient about presence of pain at incision site	6 months
Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale	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	8 weeks
Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale	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	6 months
Pain Score on Movement	Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable	48 hours after surgery

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Ashraf Habib, MD, Duke University

Publications and helpful links

General Publications

• Barney EZ, Pedro CD, Gamez BH, Fuller ME, Dominguez JE, Habib AS. Ropivacaine and Ketorolac Wound Infusion for Post-Cesarean Delivery Analgesia: A Randomized Controlled Trial. Obstet Gynecol. 2020 Feb;135(2):427-435. doi: 10.1097/AOG.0000000000003601.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: July 8, 2016
• First Submitted That Met QC Criteria: July 8, 2016
• First Posted (Estimate): July 12, 2016

Study Record Updates

• Last Update Posted (Actual): March 6, 2020
• Last Update Submitted That Met QC Criteria: February 21, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Cesarean section
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Anesthetics, Local; Ketorolac; Ropivacaine
• Other Study ID Numbers: Pro00069752