Trial Outcomes & Findings for Pain Study of Rectus Muscle Closure at Cesarean Delivery (NCT NCT00505362)

Results Overview

Post-operative pain was assessed using Silverman Integrated Assessment (SIA) pain score which combines the opioid use and movement pain score over the 72-hour study period. The SIA pain and opioid score is calculated by first rank ordering each patient's total opioid use (morphine milligram equivalents) and area under the curve (AUC) movement pain score over the 72 hour study period, then calculating a mean for both opioid use and movement pain scores, expressing both opioid use and movement pain score as percent differences from the mean, and lastly adding the percent differences from the mean for the two variables. The SIA composite score value for each subject ranges from approximately 200% to approximately -200%, with the highest positive score indicating the least comfortable or the most pain despite the greatest use of analgesics, and the lowest score indicating the most comfortable or least pain despite the least use of analgesics.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

63 participants

Primary outcome timeframe

72-hour study period

Results posted on

2017-11-06

Participant Flow

Participant milestones

Participant milestones
Measure	Rectus Muscle Closure Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures. Rectus closure: Reapproximation of the rectus muscles with three-interrupted sutures	Rectus Muscle Non-closure Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure.
Overall Study STARTED	35	28
Overall Study COMPLETED	35	28
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pain Study of Rectus Muscle Closure at Cesarean Delivery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rectus Muscle Closure n=35 Participants Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures. Rectus closure: Reapproximation of the rectus muscles with three-interrupted sutures	Rectus Muscle Non-closure n=28 Participants Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure.	Total n=63 Participants Total of all reporting groups
Age, Continuous	31 years STANDARD_DEVIATION 7 • n=5 Participants	33 years STANDARD_DEVIATION 7 • n=7 Participants	32 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	28 Participants n=7 Participants	63 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	35 Participants n=5 Participants	28 Participants n=7 Participants	63 Participants n=5 Participants
Gestational age at delivery	39 weeks n=5 Participants	38 weeks n=7 Participants	39 weeks n=5 Participants

PRIMARY outcome

Timeframe: 72-hour study period

Post-operative pain was assessed using Silverman Integrated Assessment (SIA) pain score which combines the opioid use and movement pain score over the 72-hour study period. The SIA pain and opioid score is calculated by first rank ordering each patient's total opioid use (morphine milligram equivalents) and area under the curve (AUC) movement pain score over the 72 hour study period, then calculating a mean for both opioid use and movement pain scores, expressing both opioid use and movement pain score as percent differences from the mean, and lastly adding the percent differences from the mean for the two variables. The SIA composite score value for each subject ranges from approximately 200% to approximately -200%, with the highest positive score indicating the least comfortable or the most pain despite the greatest use of analgesics, and the lowest score indicating the most comfortable or least pain despite the least use of analgesics.

Outcome measures

Outcome measures
Measure	Rectus Muscle Closure n=35 Participants Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures. Rectus closure: Reapproximation of the rectus muscles with three-interrupted sutures	Rectus Muscle Non-closure n=28 Participants Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure.
Post-operative Pain	15 Scores on a scale Standard Deviation 100	-31 Scores on a scale Standard Deviation 78

SECONDARY outcome

Timeframe: From start to the end of the cesarean delivery, assessed up to two hours.

Operative time of the cesarean delivery in minutes.

Outcome measures

Outcome measures
Measure	Rectus Muscle Closure n=35 Participants Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures. Rectus closure: Reapproximation of the rectus muscles with three-interrupted sutures	Rectus Muscle Non-closure n=28 Participants Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure.
Operative Times	63 minutes Standard Deviation 15	65 minutes Standard Deviation 15

Adverse Events

Rectus Muscle Closure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Rectus Muscle Non-closure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anna Girsen, Manager of Research Operations

Stanford University

Phone: 6507250499

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place