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

Primary Purpose

Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine
Ketorolac
Placebo
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Cesarean section

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Duke University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ropivacaine

Placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain Scores at Rest
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Pain Scores at Rest
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Pain Scores at Rest
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Opioid Consumption
measured in mg oxycodone equivalents
Opioid Consumption
measured in mg oxycodone equivalents
Opioid Consumption
measured in mg oxycodone equivalents
Time to First Rescue Analgesic
Number of Subjects Experiencing Nausea
Asking patients whether or not they experienced the symptom in the preceding time-frame
Number of Subjects Experiencing Nausea
Asking patients whether or not they experienced the symptom in the preceding time-frame
Number of Subjects Experiencing Nausea
Asking patients whether or not they experienced the symptom in the preceding time-frame
Number of Subjects Experiencing Vomiting
Asking patients whether or not they experienced the symptom in the preceding time-frame
Number of Subjects Experiencing Vomiting
Asking patients whether or not they experienced the symptom in the preceding time-frame
Number of Subjects Experiencing Vomiting
Asking patients whether or not they experienced the symptom in the preceding time-frame
Number of Subjects Experiencing Pruritus
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Number of Subjects Experiencing Pruritus
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Number of Subjects Experiencing Pruritus
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
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
Number of Subjects With Chronic Pain
Phone interview asking patient about presence of pain at incision site
Number of Subjects With Chronic Pain
Phone interview asking patient about presence of pain at incision site
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
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
Pain Score on Movement
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable

Full Information

First Posted
July 8, 2016
Last Updated
February 21, 2020
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02829944
Brief Title
Impact of Local Anesthetic Wound Infiltration on Postoperative Pain Following Cesarean Delivery
Official Title
Impact of Local Anesthetic Wound Infiltration on Postoperative Pain Following Cesarean Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Cesarean section

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Pain Score on Movement (Sitting in Bed From a Supine Position)
Description
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Pain Scores at Rest
Description
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Time Frame
2 hours
Title
Pain Scores at Rest
Description
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Time Frame
24 hours
Title
Pain Scores at Rest
Description
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Time Frame
48 hours
Title
Opioid Consumption
Description
measured in mg oxycodone equivalents
Time Frame
2 hours
Title
Opioid Consumption
Description
measured in mg oxycodone equivalents
Time Frame
24 hours
Title
Opioid Consumption
Description
measured in mg oxycodone equivalents
Time Frame
48 hours
Title
Time to First Rescue Analgesic
Time Frame
48 hours
Title
Number of Subjects Experiencing Nausea
Description
Asking patients whether or not they experienced the symptom in the preceding time-frame
Time Frame
2 hours
Title
Number of Subjects Experiencing Nausea
Description
Asking patients whether or not they experienced the symptom in the preceding time-frame
Time Frame
24 hours
Title
Number of Subjects Experiencing Nausea
Description
Asking patients whether or not they experienced the symptom in the preceding time-frame
Time Frame
48 hours
Title
Number of Subjects Experiencing Vomiting
Description
Asking patients whether or not they experienced the symptom in the preceding time-frame
Time Frame
2 hours
Title
Number of Subjects Experiencing Vomiting
Description
Asking patients whether or not they experienced the symptom in the preceding time-frame
Time Frame
24 hours
Title
Number of Subjects Experiencing Vomiting
Description
Asking patients whether or not they experienced the symptom in the preceding time-frame
Time Frame
48 hours
Title
Number of Subjects Experiencing Pruritus
Description
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Time Frame
2 hours
Title
Number of Subjects Experiencing Pruritus
Description
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Time Frame
24 hours
Title
Number of Subjects Experiencing Pruritus
Description
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Time Frame
48 hours
Title
Patient Satisfaction With Postoperative Analgesia on a 0-10 Scale
Description
Score reported on a scale of 0-10, with 0 being not at all satisfied and 10 being completely satisfied
Time Frame
48 hours
Title
Number of Subjects With Chronic Pain
Description
Phone interview asking patient about presence of pain at incision site
Time Frame
8 weeks
Title
Number of Subjects With Chronic Pain
Description
Phone interview asking patient about presence of pain at incision site
Time Frame
6 months
Title
Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale
Description
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
Time Frame
8 weeks
Title
Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale
Description
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
Time Frame
6 months
Title
Pain Score on Movement
Description
Score reported on a scale of 0-10, with 0 being none and 10 being the worst imaginable
Time Frame
48 hours after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashraf Habib, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31923061
Citation
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.
Results Reference
derived

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

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