Post-operative Cesarean Trial of Pain Control

Study Overview
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Brief Summary
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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.

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

Conditions
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Post-operative Pain, Cesarean Section

Intervention / Treatment
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* Device: ON-Q Pump® with continuous infusion of bupivacaine
* Device: ON-Q Pump® with continuous infusion of saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Saline<br>ON-Q Pump® with continuous infusion of saline (270 mL of normal saline) | Device: ON-Q Pump® with continuous infusion of saline<br>* 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.<br>|
| Experimental: Bupivacaine<br>ON-Q Pump® with continuous infusion of bupivacaine (270 ml of 0.5 % bupivacaine) | Device: ON-Q Pump® with continuous infusion of bupivacaine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total postoperative opioid use | Total postoperative opioid use in morphine equivalents through discharge | Post-operative day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| Antiemetic use at Baseline | Daily antiemetic use by number of doses through discharge | Baseline | 
| Antiemetic use at post-operative day 1 | Daily antiemetic use by number of doses through discharge | Post-operative day 1 | 
| Antiemetic use at post-operative day 2 | Daily antiemetic use by number of doses through discharge | Post-operative day 2 | 
| Antiemetic use at post-operative day 3 | Daily antiemetic use by number of doses through discharge | Post-operative day 3 | 
| Antiemetic use at post-operative day 4 | Daily antiemetic use by number of doses through discharge | Post-operative day 4 | 
| 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) | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Time to advance to regular diet | Time to advance to regular diet through discharge | Up to post-operative day 4 | 
| Time to first ambulation | Time to first ambulation | Up to post-operative day 4 | 
| Return on bowel function | Return on bowel function (pass gas or bowel movement) | Up to post-operative day 4 | 
| 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) |