Post-operative Cesarean Trial of Pain Control
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorUniversity of Colorado, Denver
About this trial
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
This trial does not accept healthy volunteersQualifiers
Pregnant patients 18 years of age or older
Patients undergoing both scheduled and unscheduled cesarean deliveries at CFCC
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
ON-Q Pump® with continuous infusion of bupivacaine
Device270 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
Device270 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: SalinePlacebo comparator 1 intervention
Group B: BupivacaineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Total postoperative opioid use
Total postoperative opioid use in morphine equivalents through discharge
Time frame
Post-operative day 4Secondary outcomes
1
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 \[100-mm scale\]).
Time frame
At hospital discharge (about post-operative day 5)2
Antiemetic use at Baseline
Daily antiemetic use by number of doses through discharge
Time frame
Baseline3
Antiemetic use at post-operative day 1
Daily antiemetic use by number of doses through discharge
Time frame
Post-operative day 14
Antiemetic use at post-operative day 2
Daily antiemetic use by number of doses through discharge
Time frame
Post-operative day 2Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
Avanos Medical
Collaborator
Children's Hospital Colorado
Collaborator
Colorado Fetal Care Center
Collaborator
Source ClinicalTrials.gov