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Post-operative Cesarean Trial of Pain Control

Primary Purpose

Post-operative Pain, Cesarean Section

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ON-Q Pump® with continuous infusion of bupivacaine
ON-Q Pump® with continuous infusion of saline
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Pregnant patients 18 years of age or older
  • Patients undergoing both scheduled and unscheduled cesarean deliveries at CFCC

Exclusion Criteria:

  • Active substance abuse (ex methamphetamines) determined by patient report, toxin screen, or screening physician's determination
  • Current treatment for chronic pain involving opiate receptor agonism or antagonism (i.e. suboxone, methadone, naltrexone, oxycodone)
  • Contraindication to neuraxial anesthesia
  • Known allergies to common anesthetic medications
  • Inability to consent to study procedures
  • Patient receiving general anesthesia

Sites / Locations

  • Children's Hospital ColoradoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Saline

Bupivacaine

Arm Description

ON-Q Pump® with continuous infusion of saline (270 mL of normal saline)

ON-Q Pump® with continuous infusion of bupivacaine (270 ml of 0.5 % bupivacaine)

Outcomes

Primary Outcome Measures

Total postoperative opioid use
Total postoperative opioid use in morphine equivalents through discharge

Secondary Outcome Measures

Patient satisfaction survey with Visual Analog Scale (VAS) Pain Score
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).
Antiemetic use at Baseline
Daily antiemetic use by number of doses through discharge
Antiemetic use at post-operative day 1
Daily antiemetic use by number of doses through discharge
Antiemetic use at post-operative day 2
Daily antiemetic use by number of doses through discharge
Antiemetic use at post-operative day 3
Daily antiemetic use by number of doses through discharge
Antiemetic use at post-operative day 4
Daily antiemetic use by number of doses through discharge
Antiemetic use at hospital discharge (about post-operative day 5)
Daily antiemetic use by number of doses through discharge
Visual Analog Scale (VAS) Pain Score at Baseline
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).
Visual Analog Scale (VAS) Pain Score at post-operative day 1
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).
Visual Analog Scale (VAS) Pain Score at post-operative day 2
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).
Visual Analog Scale (VAS) Pain Score at post-operative day 3
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).
Visual Analog Scale (VAS) Pain Score at post-operative day 4
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).
Time to advance to regular diet
Time to advance to regular diet through discharge
Time to first ambulation
Time to first ambulation
Return on bowel function
Return on bowel function (pass gas or bowel movement)
Edinburgh Depression scale at hospital discharge (about post-operative day 5)
The 10-item Edinburgh Depression Scale (EDS) measures depressive symptoms. It includes three sub-scales: anhedonia, anxiety and depression. Possible total scores range from 0 to 30, with higher scores indicating more depressive symptoms and a worse outcome.

Full Information

First Posted
November 10, 2021
Last Updated
December 19, 2022
Sponsor
University of Colorado, Denver
Collaborators
Avanos Medical, Children's Hospital Colorado, Colorado Fetal Care Center
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1. Study Identification

Unique Protocol Identification Number
NCT05131178
Brief Title
Post-operative Cesarean Trial of Pain Control
Official Title
Double Blind Randomized Trial of Post-operative Cesarean Continuous Infusion of Bupivacaine Versus Placebo for Local Incisional Pain Control
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Avanos Medical, Children's Hospital Colorado, Colorado Fetal Care Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study plans to learn more about postoperative pain management after cesarean deliveries (C-sections). As a part of standard of care, the Children's Hospital Colorado's Colorado Fetal Care Center (CFCC) follows the standard Enhanced Recovery After Cesarean (ERAC) guidelines to manage pain following C-section delivery. In addition, the CFCC uses an FDA approved medical device called the ON-Q ® Pump, which continuously delivers local anesthetic medication to control pain in the area of your procedure. The local anesthetic used is bupivacaine, which is FDA approved for use to control local pain after C-sections. The CFCC has found a significant reduction in opioid use after adopting both of these procedures. The study aims to determine if the ERAC protocol or ON-Q ® Pump continuous infusion is responsible for lower opioid use by comparing bupivacaine (treatment) versus saline (placebo) groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain, Cesarean Section

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
ON-Q Pump® with continuous infusion of saline (270 mL of normal saline)
Arm Title
Bupivacaine
Arm Type
Experimental
Arm Description
ON-Q Pump® with continuous infusion of bupivacaine (270 ml of 0.5 % bupivacaine)
Intervention Type
Device
Intervention Name(s)
ON-Q Pump® with continuous infusion of bupivacaine
Intervention Description
270 ml of 0.5 % bupivacaine. The device being used is a fixed flow pump meaning the rate of 2 mL/hour. The pump is connected to the catheter and left in place for up to 4 post-operative days or until the completion of the infusion.
Intervention Type
Device
Intervention Name(s)
ON-Q Pump® with continuous infusion of saline
Intervention Description
270 mL of normal saline. The device being used is a fixed flow pump meaning the rate of 2 mL/hour. The pump is connected to the catheter and left in place for up to 4 post-operative days or until the completion of the infusion.
Primary Outcome Measure Information:
Title
Total postoperative opioid use
Description
Total postoperative opioid use in morphine equivalents through discharge
Time Frame
Post-operative day 4
Secondary Outcome Measure Information:
Title
Patient satisfaction survey with Visual Analog Scale (VAS) Pain Score
Description
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).
Time Frame
At hospital discharge (about post-operative day 5)
Title
Antiemetic use at Baseline
Description
Daily antiemetic use by number of doses through discharge
Time Frame
Baseline
Title
Antiemetic use at post-operative day 1
Description
Daily antiemetic use by number of doses through discharge
Time Frame
Post-operative day 1
Title
Antiemetic use at post-operative day 2
Description
Daily antiemetic use by number of doses through discharge
Time Frame
Post-operative day 2
Title
Antiemetic use at post-operative day 3
Description
Daily antiemetic use by number of doses through discharge
Time Frame
Post-operative day 3
Title
Antiemetic use at post-operative day 4
Description
Daily antiemetic use by number of doses through discharge
Time Frame
Post-operative day 4
Title
Antiemetic use at hospital discharge (about post-operative day 5)
Description
Daily antiemetic use by number of doses through discharge
Time Frame
At hospital discharge (about post-operative day 5)
Title
Visual Analog Scale (VAS) Pain Score at Baseline
Description
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).
Time Frame
Baseline
Title
Visual Analog Scale (VAS) Pain Score at post-operative day 1
Description
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).
Time Frame
Post-operative day 1
Title
Visual Analog Scale (VAS) Pain Score at post-operative day 2
Description
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).
Time Frame
Post-operative day 2
Title
Visual Analog Scale (VAS) Pain Score at post-operative day 3
Description
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).
Time Frame
Post-operative day 3
Title
Visual Analog Scale (VAS) Pain Score at post-operative day 4
Description
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).
Time Frame
Post-operative day 4
Title
Time to advance to regular diet
Description
Time to advance to regular diet through discharge
Time Frame
Up to post-operative day 4
Title
Time to first ambulation
Description
Time to first ambulation
Time Frame
Up to post-operative day 4
Title
Return on bowel function
Description
Return on bowel function (pass gas or bowel movement)
Time Frame
Up to post-operative day 4
Title
Edinburgh Depression scale at hospital discharge (about post-operative day 5)
Description
The 10-item Edinburgh Depression Scale (EDS) measures depressive symptoms. It includes three sub-scales: anhedonia, anxiety and depression. Possible total scores range from 0 to 30, with higher scores indicating more depressive symptoms and a worse outcome.
Time Frame
At hospital discharge (about post-operative day 5)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pregnant patients 18 years of age or older Patients undergoing both scheduled and unscheduled cesarean deliveries at CFCC Exclusion Criteria: Active substance abuse (ex methamphetamines) determined by patient report, toxin screen, or screening physician's determination Current treatment for chronic pain involving opiate receptor agonism or antagonism (i.e. suboxone, methadone, naltrexone, oxycodone) Contraindication to neuraxial anesthesia Known allergies to common anesthetic medications Inability to consent to study procedures Patient receiving general anesthesia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Research Coordinator
Phone
(855) 413-3825
Email
Halley.Isberg@childrenscolorado.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Zaretsky, MD
Organizational Affiliation
Children's Hospital Colorado - Colorado Fetal Care Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liz Torres
Phone
720-777-1661
Email
Elizabeth.Torres@childrenscolorado.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Post-operative Cesarean Trial of Pain Control

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