Trial · NCT03929640
Management Of Pain After Cesarean Trial
NCT03929640, Phase 3, Terminated, Milton S. Hershey Medical Center; results first posted 2024-09-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Management Of Pain After Cesarean Trial. Trials, record NCT03929640. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03929640
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Management Of Pain After Cesarean Trial
- NCT number
- NCT03929640
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 49 participants, actual
- Lead sponsor
- Milton S. Hershey Medical Center
- Conditions
- Pain, Postoperative, Opioid Use
- Interventions
- Acetaminophen, Placebo, Ibuprofen
- First posted
- 2019-04-29
- Last updated
- 2024-09-04
- Results first posted
- 2024-09-04
- Limitations and caveats
Enrollment was suspended when the co-investigator responsible for study recruitment left the institution in 2020. At that time, only 49 subjects had been randomized (study enrollment goal was 150 subjects). The PI kept the study open but was not successful in finding a replacement to lead the study so it was eventually terminated.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain Score | 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) | 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. |
| Secondary | Opiate Consumption in Hospital | Post-operative day 0 (day of surgery) until discharged from hospital on post-operative day 3 or 4. | Total number of oxycodone 5 mg tablets taken during hospital admission after cesarean section surgery |
| Secondary | WHOQOL-BREF Score, Domain 1 | Post-operative Day 14 (two weeks after cesarean section surgery) | 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. |
| Secondary | WHOQOL-BREF Score, Domain 2 | Post-operative Day 14 (two weeks after cesarean section surgery) | 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. |
| Secondary | WHOQOL-BREF Score, Domain 3 | Post-operative Day 14 (two weeks after cesarean section surgery) | 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. |
| Secondary | WHOQOL-BREF Score, Domain 4 | Post-operative Day 14 (two weeks after cesarean section surgery) | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pain Score | 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) | Participants having a post-op day 2 (mid-day) pain score in their charts. | score on a scale | MEAN |
| SECONDARY | Opiate Consumption in Hospital | Post-operative day 0 (day of surgery) until discharged from hospital on post-operative day 3 or 4. | Subjects with available data in their charts | number of tablets | MEDIAN |
| SECONDARY | WHOQOL-BREF Score, Domain 1 | Post-operative Day 14 (two weeks after cesarean section surgery) | subjects completing this survey | score on a scale | MEAN |
| SECONDARY | WHOQOL-BREF Score, Domain 2 | Post-operative Day 14 (two weeks after cesarean section surgery) | subjects completing this survey | score on a scale | MEAN |
| SECONDARY | WHOQOL-BREF Score, Domain 3 | Post-operative Day 14 (two weeks after cesarean section surgery) | subjects completing this survey | score on a scale | MEAN |
| SECONDARY | WHOQOL-BREF Score, Domain 4 | Post-operative Day 14 (two weeks after cesarean section surgery) | subjects who completed the survey | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pain Score | Ibuprofen and Placebo | 3.5 | Standard Deviation 2.3 | score on a scale | |
| Pain Score | Ibuprofen and Acetaminophen | 3.3 | Standard Deviation 2.4 | score on a scale | |
| Opiate Consumption in Hospital | Ibuprofen and Placebo | 10 | Inter-Quartile Range 1 to 20 | number of tablets | |
| Opiate Consumption in Hospital | Ibuprofen and Acetaminophen | 9 | Inter-Quartile Range 0 to 17 | number of tablets | |
| WHOQOL-BREF Score, Domain 1 | Ibuprofen and Placebo | 15.6 | Standard Deviation 2.3 | score on a scale | |
| WHOQOL-BREF Score, Domain 1 | Ibuprofen and Acetaminophen | 16.2 | Standard Deviation 2.6 | score on a scale | |
| WHOQOL-BREF Score, Domain 2 | Ibuprofen and Placebo | 15.6 | Standard Deviation 2.8 | score on a scale | |
| WHOQOL-BREF Score, Domain 2 | Ibuprofen and Acetaminophen | 16.4 | Standard Deviation 1.7 | score on a scale | |
| WHOQOL-BREF Score, Domain 3 | Ibuprofen and Placebo | 15.4 | Standard Deviation 2.9 | score on a scale | |
| WHOQOL-BREF Score, Domain 3 | Ibuprofen and Acetaminophen | 17.1 | Standard Deviation 2.3 | score on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ibuprofen and Placebo | 24 | |
| Overall Study | STARTED | Ibuprofen and Acetaminophen | 25 | |
| Overall Study | Received Study Drug | Ibuprofen and Placebo | 20 | |
| Overall Study | Received Study Drug | Ibuprofen and Acetaminophen | 21 | |
| Overall Study | COMPLETED | Ibuprofen and Placebo | 18 | |
| Overall Study | COMPLETED | Ibuprofen and Acetaminophen | 16 | |
| Overall Study | NOT COMPLETED | Ibuprofen and Placebo | 6 | |
| Overall Study | NOT COMPLETED | Ibuprofen and Acetaminophen | 9 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ibuprofen and Placebo | 0 | 20 |
| Total, all-cause mortality | Ibuprofen and Acetaminophen | 0 | 21 |
| Total, other adverse events | Ibuprofen and Placebo | 0 | 20 |
| Total, other adverse events | Ibuprofen and Acetaminophen | 0 | 21 |
| Total, serious adverse events | Ibuprofen and Placebo | 0 | 20 |
| Total, serious adverse events | Ibuprofen and Acetaminophen | 0 | 21 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ibuprofen and Placebo vs Ibuprofen and Acetaminophen: deaths from any cause | Trial comparisons |
| Ibuprofen and Placebo vs Ibuprofen and Acetaminophen: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03929640
GET https://conductscience.org/api/trials/v1/NCT03929640/registered