Cesarean Section, Post-operative Pain
Conditions
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.
Interventions
DEVICEON-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.
DEVICEON-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.
Sponsors
University of Colorado, Denver
Avanos Medical
Children's Hospital Colorado
Colorado Fetal Care Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total postoperative opioid use | Post-operative day 4 | Total postoperative opioid use in morphine equivalents through discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Baseline | Baseline | Daily antiemetic use by number of doses through discharge |
| Antiemetic use at post-operative day 1 | Post-operative day 1 | Daily antiemetic use by number of doses through discharge |
| 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 |
| Antiemetic use at post-operative day 4 | Post-operative day 4 | Daily antiemetic use by number of doses 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 |
| 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 \[100-mm scale\]). |
| 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 \[100-mm scale\]). |
| 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 \[100-mm scale\]). |
| 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 \[100-mm scale\]). |
| Time to advance to regular diet | Up to post-operative day 4 | Time to advance to regular diet through discharge |
| Time to first ambulation | Up to post-operative day 4 | Time to first ambulation |
| 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. |
Countries
United States
Contacts
CONTACTClinical Research Manager
CONTACTDeion Pena
PRINCIPAL_INVESTIGATORMichael Zaretsky, MD
Children's Hospital Colorado - Colorado Fetal Care Center
Outcome results
None listed