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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
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.
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.
Children's Hospital Colorado
Aurora, Colorado, United States
RECRUITINGTotal postoperative opioid use
Total postoperative opioid use in morphine equivalents through discharge
Time frame: Post-operative day 4
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)
Antiemetic use at Baseline
Daily antiemetic use by number of doses through discharge
Time frame: Baseline
Antiemetic use at post-operative day 1
Daily antiemetic use by number of doses through discharge
Time frame: Post-operative day 1
Antiemetic use at post-operative day 2
Daily antiemetic use by number of doses through discharge
Time frame: Post-operative day 2
Antiemetic use at post-operative day 3
Daily antiemetic use by number of doses through discharge
Time frame: Post-operative day 3
Antiemetic use at post-operative day 4
Daily antiemetic use by number of doses through discharge
Time frame: Post-operative day 4
Antiemetic use at hospital discharge (about post-operative day 5)
Daily antiemetic use by number of doses through discharge
Time frame: 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 \[100-mm scale\]).
Time frame: 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 \[100-mm scale\]).
Time frame: 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 \[100-mm scale\]).
Time frame: 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 \[100-mm scale\]).
Time frame: 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 \[100-mm scale\]).
Time frame: Post-operative day 4
Time to advance to regular diet
Time to advance to regular diet through discharge
Time frame: Up to post-operative day 4
Time to first ambulation
Time to first ambulation
Time frame: Up to post-operative day 4
Return on bowel function
Return on bowel function (pass gas or bowel movement)
Time frame: 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.
Time frame: At hospital discharge (about post-operative day 5)
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