Trial · NCT04175509
Improving Post-Operative Pain and Recovery in Gynecologic Surgery
NCT04175509, Phase 4, Completed, Aultman Health Foundation; results first posted 2021-08-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Improving Post-Operative Pain and Recovery in Gynecologic Surgery. Trials, record NCT04175509. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04175509
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Improving Post-Operative Pain and Recovery in Gynecologic Surgery
- NCT number
- NCT04175509
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 40 participants, actual
- Lead sponsor
- Aultman Health Foundation
- Conditions
- Postoperative Pain, Opioid Use, Acetaminophen
- Interventions
- Rectal acetaminophen, Intravenous acetaminophen
- First posted
- 2019-11-25
- Last updated
- 2022-01-20
- Results first posted
- 2021-08-19
- Limitations and caveats
Due to the COVID-19 pandemic, many patients were prohibited to stay overnight in the hospital. Therefore, many patients were discharged home before 24 hours after surgery. This is primarily why the primary and secondary outcomes were analyzed at shorter time intervals (6 hours post-op and 12 hours-op) as well.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Postoperative Pain: Standardized Pain Scale | The first 24 hours following surgery, or upon discharge, whichever comes first. | Post-operative pain control using a standardized pain scale from 0 (no pain) to 10 (worse pain) measured every 4 hours for the 24 hours, or discharge, whichever comes first. Time points were averaged for each participate and reported as a single value. |
| Secondary | Opioid Use | The first 24 hours following surgery, or upon discharge, whichever comes first. | Total amount of opioid rescue calculated by converting all opiates to Morphine Milligram Equivalents in the first 24 hours following surgery, or upon discharge, whichever comes first. |
| Other | Postoperative Pain: Standardized Pain Scale | The first 6 hours following surgery | Post-operative pain control using a standardized pain scale from 0 (no pain) to 10 (worse pain) for the first 6 hours after surgery. Time points were averaged for each participate and reported as a single value. |
| Other | Postoperative Pain: Standardized Pain Scale | The 12 hours following surgery | Post-operative pain control using a standardized pain scale from 0 (no pain) to 10 (worse pain) for the first 12 hours after surgery. Time points were averaged for each participate and reported as a single value. |
| Other | Opioid Use | The first 6 hours following surgery | Total amount of opioid rescue calculated by converting all opiates to Morphine Milligram Equivalents in the first 6 hours following surgery |
| Other | Opioid Use | The first 12 hours following surgery | Total amount of opioid rescue calculated by converting all opiates to Morphine Milligram Equivalents in the first 12 hours following surgery |
| Other | Estimated Blood Loss | During the duration of the surgery, from start to end time, on average 1.5 hours | Total estimated blood loss in millilitres for the surgery |
| Other | Operative Time | From the start to end of the surgery | Operative time in minutes determined by the operating room record |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Postoperative Pain: Standardized Pain Scale | The first 24 hours following surgery, or upon discharge, whichever comes first. | score on a scale | MEAN | |
| SECONDARY | Opioid Use | The first 24 hours following surgery, or upon discharge, whichever comes first. | Morphine Milligram Equivalents | MEAN | |
| OTHER_PRE_SPECIFIED | Postoperative Pain: Standardized Pain Scale | The first 6 hours following surgery | Two participants in the intravenous acetaminophen group were discharged home prior to 6 hours after surgery and therefore were not included in the analysis. | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Postoperative Pain: Standardized Pain Scale | The 12 hours following surgery | One participant in the rectal acetaminophen group, and 3 participants in the intravenous acetaminophen group were discharged home prior to 12 hours after surgery and therefore were not included in the analysis. | score on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Opioid Use | The first 6 hours following surgery | Morphine Milligram Equivalents | MEAN | |
| OTHER_PRE_SPECIFIED | Opioid Use | The first 12 hours following surgery | Morphine Milligram Equivalents | MEAN | |
| OTHER_PRE_SPECIFIED | Estimated Blood Loss | During the duration of the surgery, from start to end time, on average 1.5 hours | Millilitres | MEAN | |
| OTHER_PRE_SPECIFIED | Operative Time | From the start to end of the surgery | Minutes | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Postoperative Pain: Standardized Pain Scale | Rectal Acetaminophen | 2.82 | Standard Deviation 1.11 | score on a scale | |
| Postoperative Pain: Standardized Pain Scale | Intravenous Acetaminophen | 3.18 | Standard Deviation 1.26 | score on a scale | |
| Opioid Use | Rectal Acetaminophen | 25.75 | Standard Deviation 20.09 | Morphine Milligram Equivalents | |
| Opioid Use | Intravenous Acetaminophen | 23.71 | Standard Deviation 18.46 | Morphine Milligram Equivalents | |
| Postoperative Pain: Standardized Pain Scale | Rectal Acetaminophen | 3.13 | Standard Deviation 1.36 | score on a scale | |
| Postoperative Pain: Standardized Pain Scale | Intravenous Acetaminophen | 1.36 | Standard Deviation 1.78 | score on a scale | |
| Postoperative Pain: Standardized Pain Scale | Rectal Acetaminophen | 2.99 | Standard Deviation 1.20 | score on a scale | |
| Postoperative Pain: Standardized Pain Scale | Intravenous Acetaminophen | 3.36 | Standard Deviation 1.43 | score on a scale | |
| Opioid Use | Rectal Acetaminophen | 6.74 | Standard Deviation 7.49 | Morphine Milligram Equivalents | |
| Opioid Use | Intravenous Acetaminophen | 7.97 | Standard Deviation 6.28 | Morphine Milligram Equivalents |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rectal Acetaminophen | 19 | |
| Overall Study | STARTED | Intravenous Acetaminophen | 21 | |
| Overall Study | COMPLETED | Rectal Acetaminophen | 17 | |
| Overall Study | COMPLETED | Intravenous Acetaminophen | 19 | |
| Overall Study | NOT COMPLETED | Rectal Acetaminophen | 2 | |
| Overall Study | NOT COMPLETED | Intravenous Acetaminophen | 2 |
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 | Rectal Acetaminophen | 0 | 19 |
| Total, all-cause mortality | Intravenous Acetaminophen | 0 | 21 |
| Total, other adverse events | Rectal Acetaminophen | 0 | 19 |
| Total, other adverse events | Intravenous Acetaminophen | 0 | 21 |
| Total, serious adverse events | Rectal Acetaminophen | 0 | 19 |
| Total, serious adverse events | Intravenous Acetaminophen | 0 | 21 |
Source ClinicalTrials.gov
Papers3
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 |
|---|---|
| Rectal Acetaminophen vs Intravenous Acetaminophen: deaths from any cause | Trial comparisons |
| Rectal Acetaminophen vs Intravenous 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/NCT04175509
GET https://conductscience.org/api/trials/v1/NCT04175509/registered