Post-operative Cesarean Trial of Pain Control

Cesarean Section Clinical Trial

Official title:

Double Blind Randomized Trial of Post-operative Cesarean Continuous Infusion of Bupivacaine Versus Placebo for Local Incisional Pain Control

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05131178
• Other study ID #: 21-2810
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: University of Colorado, Denver
• Contact: Clinical Research Coordinator
• Phone: (855) 413-3825
• Email: Halley.Isberg[@]childrenscolorado.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Pain, Postoperative
• Post-operative Pain

Intervention

Device:
• ON-Q Pump® with continuous infusion of bupivacaine
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.
• ON-Q Pump® with continuous infusion of saline
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.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (4)

Lead Sponsor	Collaborator
University of Colorado, Denver	Avanos Medical, Children's Hospital Colorado, Colorado Fetal Care Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total postoperative opioid use	Total postoperative opioid use in morphine equivalents through discharge	Post-operative day 4
Secondary	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]).	At hospital discharge (about post-operative day 5)
Secondary	Antiemetic use at Baseline	Daily antiemetic use by number of doses through discharge	Baseline
Secondary	Antiemetic use at post-operative day 1	Daily antiemetic use by number of doses through discharge	Post-operative day 1
Secondary	Antiemetic use at post-operative day 2	Daily antiemetic use by number of doses through discharge	Post-operative day 2
Secondary	Antiemetic use at post-operative day 3	Daily antiemetic use by number of doses through discharge	Post-operative day 3
Secondary	Antiemetic use at post-operative day 4	Daily antiemetic use by number of doses through discharge	Post-operative day 4
Secondary	Antiemetic use at hospital discharge (about post-operative day 5)	Daily antiemetic use by number of doses through discharge	At hospital discharge (about post-operative day 5)
Secondary	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]).	Baseline
Secondary	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]).	Post-operative day 1
Secondary	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]).	Post-operative day 2
Secondary	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]).	Post-operative day 3
Secondary	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]).	Post-operative day 4
Secondary	Time to advance to regular diet	Time to advance to regular diet through discharge	Up to post-operative day 4
Secondary	Time to first ambulation	Time to first ambulation	Up to post-operative day 4
Secondary	Return on bowel function	Return on bowel function (pass gas or bowel movement)	Up to post-operative day 4
Secondary	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.	At hospital discharge (about post-operative day 5)