Clinical trial NCT05131178: 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
Overall status: RECRUITING
Phase: NA
Conditions: Post-operative Pain
Cesarean Section
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Avanos Medical
name: Children's Hospital Colorado
name: Colorado Fetal Care Center
First posted: 2021-11-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Total postoperative opioid use
timeFrame: Post-operative day 4
Secondary outcomes:
measure: Patient satisfaction survey with Visual Analog Scale (VAS) Pain Score
timeFrame: At hospital discharge (about post-operative day 5)
measure: Antiemetic use at Baseline
timeFrame: Baseline
measure: Antiemetic use at post-operative day 1
timeFrame: Post-operative day 1
measure: Antiemetic use at post-operative day 2
timeFrame: Post-operative day 2
measure: Antiemetic use at post-operative day 3
timeFrame: Post-operative day 3
measure: Antiemetic use at post-operative day 4
timeFrame: Post-operative day 4
measure: Antiemetic use at hospital discharge (about post-operative day 5)
timeFrame: At hospital discharge (about post-operative day 5)
measure: Visual Analog Scale (VAS) Pain Score at Baseline
timeFrame: Baseline
measure: Visual Analog Scale (VAS) Pain Score at post-operative day 1
timeFrame: Post-operative day 1
measure: Visual Analog Scale (VAS) Pain Score at post-operative day 2
timeFrame: Post-operative day 2
measure: Visual Analog Scale (VAS) Pain Score at post-operative day 3
timeFrame: Post-operative day 3
measure: Visual Analog Scale (VAS) Pain Score at post-operative day 4
timeFrame: Post-operative day 4
measure: Time to advance to regular diet
timeFrame: Up to post-operative day 4
measure: Time to first ambulation
timeFrame: Up to post-operative day 4
measure: Return on bowel function
timeFrame: Up to post-operative day 4
measure: Edinburgh Depression scale at hospital discharge (about post-operative day 5)
timeFrame: At hospital discharge (about post-operative day 5)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado - Colorado Fetal Care Center
name: Michael Zaretsky, MD
role: PRINCIPAL_INVESTIGATOR
References: