Trial Outcomes & Findings for Management Of Pain After Cesarean Trial (NCT NCT03929640)

Last Updated: 2024-09-04

Results Overview

Pain score on a scale of 0 (no pain) to 10 (worst pain); "pain score" is a verbal report of participant pain on a scale of 0-10, 0 indicating no pain and incrementally increasing as integer to a maximum score of 10 indicating the most severe pain possible.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

49 participants

Primary outcome timeframe

Post-operative day 2, corresponding to 2 days after cesarean section surgery (day of surgery is considered post-operative day 0). Measurement taken mid-day (12 PM - 4 PM)

Results posted on

2024-09-04

Participant Flow

Participant milestones

Participant milestones
Measure	Ibuprofen and Placebo Oral administration of ibuprofen 600 mg tablet and placebo tablet every 6 hours Placebo: Placebo oral tablet every 6 hours Ibuprofen: Ibuprofen 600 mg tablet every 6 hours	Ibuprofen and Acetaminophen Oral administration of ibuprofen 600 mg tablet and acetaminophen 650 mg tablet every 6 hours Acetaminophen: Acetaminophen 650 mg tablet every 6 hours Ibuprofen: Ibuprofen 600 mg tablet every 6 hours
Overall Study STARTED	24	25
Overall Study Received Study Drug	20	21
Overall Study COMPLETED	18	16
Overall Study NOT COMPLETED	6	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Management Of Pain After Cesarean Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ibuprofen and Placebo n=20 Participants Oral administration of ibuprofen 600 mg tablet and placebo tablet every 6 hours Placebo: Placebo oral tablet every 6 hours Ibuprofen: Ibuprofen 600 mg tablet every 6 hours	Ibuprofen and Acetaminophen n=21 Participants Oral administration of ibuprofen 600 mg tablet and acetaminophen 650 mg tablet every 6 hours Acetaminophen: Acetaminophen 650 mg tablet every 6 hours Ibuprofen: Ibuprofen 600 mg tablet every 6 hours	Total n=41 Participants Total of all reporting groups
Age, Continuous	30.6 years STANDARD_DEVIATION 5.0 • n=5 Participants	30.0 years STANDARD_DEVIATION 9.8 • n=7 Participants	30.3 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Post-operative day 2, corresponding to 2 days after cesarean section surgery (day of surgery is considered post-operative day 0). Measurement taken mid-day (12 PM - 4 PM)

Population: Participants having a post-op day 2 (mid-day) pain score in their charts.

Outcome measures

Outcome measures
Measure	Ibuprofen and Placebo n=17 Participants Oral administration of ibuprofen 600 mg tablet and placebo tablet every 6 hours Placebo: Placebo oral tablet every 6 hours Ibuprofen: Ibuprofen 600 mg tablet every 6 hours	Ibuprofen and Acetaminophen n=17 Participants Oral administration of ibuprofen 600 mg tablet and acetaminophen 650 mg tablet every 6 hours Acetaminophen: Acetaminophen 650 mg tablet every 6 hours Ibuprofen: Ibuprofen 600 mg tablet every 6 hours
Pain Score	3.5 score on a scale Standard Deviation 2.3	3.3 score on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: Post-operative day 0 (day of surgery) until discharged from hospital on post-operative day 3 or 4.

Population: Subjects with available data in their charts

Total number of oxycodone 5 mg tablets taken during hospital admission after cesarean section surgery

Outcome measures

Outcome measures
Measure	Ibuprofen and Placebo n=18 Participants Oral administration of ibuprofen 600 mg tablet and placebo tablet every 6 hours Placebo: Placebo oral tablet every 6 hours Ibuprofen: Ibuprofen 600 mg tablet every 6 hours	Ibuprofen and Acetaminophen n=20 Participants Oral administration of ibuprofen 600 mg tablet and acetaminophen 650 mg tablet every 6 hours Acetaminophen: Acetaminophen 650 mg tablet every 6 hours Ibuprofen: Ibuprofen 600 mg tablet every 6 hours
Opiate Consumption in Hospital	10 number of tablets Interval 1.0 to 20.0	9 number of tablets Interval 0.0 to 17.0

SECONDARY outcome

Timeframe: Post-operative Day 14 (two weeks after cesarean section surgery)

Population: subjects completing this survey

Domain Score on World Health Organization Quality of Life - Brief (WHOQOL-BREF) survey. The survey consists of 26 questions and evaluates four domains of quality of life including physical health (domain 1), psychological (domain 2), social relationships (domain 3), and environment (domain 4). Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life) and range between 4-20, comparable with the WHOQOL-100.

Outcome measures

Outcome measures
Measure	Ibuprofen and Placebo n=16 Participants Oral administration of ibuprofen 600 mg tablet and placebo tablet every 6 hours Placebo: Placebo oral tablet every 6 hours Ibuprofen: Ibuprofen 600 mg tablet every 6 hours	Ibuprofen and Acetaminophen n=18 Participants Oral administration of ibuprofen 600 mg tablet and acetaminophen 650 mg tablet every 6 hours Acetaminophen: Acetaminophen 650 mg tablet every 6 hours Ibuprofen: Ibuprofen 600 mg tablet every 6 hours
WHOQOL-BREF Score, Domain 1	15.6 score on a scale Standard Deviation 2.3	16.2 score on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: Post-operative Day 14 (two weeks after cesarean section surgery)

Population: subjects completing this survey

Outcome measures

Outcome measures
Measure	Ibuprofen and Placebo n=16 Participants Oral administration of ibuprofen 600 mg tablet and placebo tablet every 6 hours Placebo: Placebo oral tablet every 6 hours Ibuprofen: Ibuprofen 600 mg tablet every 6 hours	Ibuprofen and Acetaminophen n=18 Participants Oral administration of ibuprofen 600 mg tablet and acetaminophen 650 mg tablet every 6 hours Acetaminophen: Acetaminophen 650 mg tablet every 6 hours Ibuprofen: Ibuprofen 600 mg tablet every 6 hours
WHOQOL-BREF Score, Domain 2	15.6 score on a scale Standard Deviation 2.8	16.4 score on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: Post-operative Day 14 (two weeks after cesarean section surgery)

Population: subjects completing this survey

Outcome measures

Outcome measures
Measure	Ibuprofen and Placebo n=16 Participants Oral administration of ibuprofen 600 mg tablet and placebo tablet every 6 hours Placebo: Placebo oral tablet every 6 hours Ibuprofen: Ibuprofen 600 mg tablet every 6 hours	Ibuprofen and Acetaminophen n=18 Participants Oral administration of ibuprofen 600 mg tablet and acetaminophen 650 mg tablet every 6 hours Acetaminophen: Acetaminophen 650 mg tablet every 6 hours Ibuprofen: Ibuprofen 600 mg tablet every 6 hours
WHOQOL-BREF Score, Domain 3	15.4 score on a scale Standard Deviation 2.9	17.1 score on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: Post-operative Day 14 (two weeks after cesarean section surgery)

Population: subjects who completed the survey

Outcome measures

Outcome measures
Measure	Ibuprofen and Placebo n=16 Participants Oral administration of ibuprofen 600 mg tablet and placebo tablet every 6 hours Placebo: Placebo oral tablet every 6 hours Ibuprofen: Ibuprofen 600 mg tablet every 6 hours	Ibuprofen and Acetaminophen n=18 Participants Oral administration of ibuprofen 600 mg tablet and acetaminophen 650 mg tablet every 6 hours Acetaminophen: Acetaminophen 650 mg tablet every 6 hours Ibuprofen: Ibuprofen 600 mg tablet every 6 hours
WHOQOL-BREF Score, Domain 4	17.2 score on a scale Standard Deviation 1.8	17.1 score on a scale Standard Deviation 1.6

Adverse Events

Ibuprofen and Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ibuprofen and Acetaminophen

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

Serdar Ural

Milton S. Hershey Medical Center

Phone: 717-531-6209

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place