Post-operative Cesarean Trial of Pain Control

Not Applicable

Recruiting

• Conditions: Post-operative Pain; Cesarean Section
• Interventions: Device: ON-Q Pump® with continuous infusion of saline; Device: ON-Q Pump® with continuous infusion of bupivacaine

• Registration Number: NCT05131178
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-07
• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-10
• Study First Posted: 2021-11-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-29
• Last Update Posted: 2024-04-01
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	ON-Q Pump® with continuous infusion of saline	ON-Q Pump® with continuous infusion of saline (270 mL of normal saline)
Bupivacaine	ON-Q Pump® with continuous infusion of bupivacaine	ON-Q Pump® with continuous infusion of bupivacaine (270 ml of 0.5 % bupivacaine)

Primary Outcome Measures

Name	Time	Method
Total postoperative opioid use	Post-operative day 4	Total postoperative opioid use in morphine equivalents through discharge

Secondary Outcome Measures

Name	Time	Method
Antiemetic use at post-operative day 1	Post-operative day 1	Daily antiemetic use by number of doses through discharge
Visual Analog Scale (VAS) Pain Score at post-operative day 2	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 \[100-mm scale\]).
Time to advance to regular diet	Up to post-operative day 4	Time to advance to regular diet through discharge
Antiemetic use at hospital discharge (about post-operative day 5)	At hospital discharge (about post-operative day 5)	Daily antiemetic use by number of doses through discharge
Antiemetic use at Baseline	Baseline	Daily antiemetic use by number of doses through discharge
Patient satisfaction survey with Visual Analog Scale (VAS) Pain Score	At hospital discharge (about post-operative day 5)	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 post-operative day 4	Post-operative day 4	Daily antiemetic use by number of doses through discharge
Visual Analog Scale (VAS) Pain Score at post-operative day 1	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 \[100-mm scale\]).
Antiemetic use at post-operative day 2	Post-operative day 2	Daily antiemetic use by number of doses through discharge
Antiemetic use at post-operative day 3	Post-operative day 3	Daily antiemetic use by number of doses through discharge
Visual Analog Scale (VAS) Pain Score at Baseline	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 \[100-mm scale\]).
Time to first ambulation	Up to post-operative day 4	Time to first ambulation
Visual Analog Scale (VAS) Pain Score at post-operative day 3	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	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 \[100-mm scale\]).
Return on bowel function	Up to post-operative day 4	Return on bowel function (pass gas or bowel movement)
Edinburgh Depression scale at hospital discharge (about post-operative day 5)	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.

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States