MedDataX Logo

Trial Outcomes & Findings for Improving Post-Operative Pain and Recovery in Gynecologic Surgery (NCT NCT04175509)

NCT ID: NCT04175509

Last Updated: 2022-01-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

40 participants

Primary outcome timeframe

The first 24 hours following surgery, or upon discharge, whichever comes first.

Results posted on

2022-01-20

Participant Flow

Participant milestones

Participant milestones
Measure
Rectal Acetaminophen
Patients will receive two 650mg suppositories rectally of acetaminophen for a total dose of 1300mg at the end of surgery. Rectal acetaminophen: Rectal 1300mg
Intravenous Acetaminophen
Patients will receive one dose of 1000mg of acetaminophen, administered intravenously, at the end of surgery. Intravenous acetaminophen: Intravenous 1000mg
Overall Study
STARTED
19
21
Overall Study
COMPLETED
17
19
Overall Study
NOT COMPLETED
2
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Rectal Acetaminophen
n=17 Participants
Patients will receive two 650mg suppositories rectally of acetaminophen for a total dose of 1300mg at the end of surgery. Rectal acetaminophen: Rectal 1300mg
Intravenous Acetaminophen
n=19 Participants
Patients will receive one dose of 1000mg of acetaminophen, administered intravenously, at the end of surgery. Intravenous acetaminophen: Intravenous 1000mg
Total
n=36 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=17 Participants
0 Participants
n=19 Participants
0 Participants
n=36 Participants
Age, Categorical
Between 18 and 65 years
14 Participants
n=17 Participants
17 Participants
n=19 Participants
31 Participants
n=36 Participants
Age, Categorical
>=65 years
3 Participants
n=17 Participants
2 Participants
n=19 Participants
5 Participants
n=36 Participants
Age, Continuous
50.53 years
STANDARD_DEVIATION 13.64 • n=17 Participants
52.37 years
STANDARD_DEVIATION 14.08 • n=19 Participants
51.50 years
STANDARD_DEVIATION 13.70 • n=36 Participants
Sex: Female, Male
Female
17 Participants
n=17 Participants
19 Participants
n=19 Participants
36 Participants
n=36 Participants
Sex: Female, Male
Male
0 Participants
n=17 Participants
0 Participants
n=19 Participants
0 Participants
n=36 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United States
17 participants
n=17 Participants
19 participants
n=19 Participants
36 participants
n=36 Participants
Indication for hysterectomy
Benign
11 Participants
n=17 Participants
12 Participants
n=19 Participants
23 Participants
n=36 Participants
Indication for hysterectomy
Malignant
6 Participants
n=17 Participants
7 Participants
n=19 Participants
13 Participants
n=36 Participants
Diabetes Mellitus
4 Participants
n=17 Participants
1 Participants
n=19 Participants
5 Participants
n=36 Participants
Hypertension
10 Participants
n=17 Participants
7 Participants
n=19 Participants
17 Participants
n=36 Participants
Thyroid disease
1 Participants
n=17 Participants
2 Participants
n=19 Participants
3 Participants
n=36 Participants
Pulmonary disease
5 Participants
n=17 Participants
2 Participants
n=19 Participants
7 Participants
n=36 Participants
Anxiety and/or depression
7 Participants
n=17 Participants
5 Participants
n=19 Participants
12 Participants
n=36 Participants
Obesity
11 Participants
n=17 Participants
14 Participants
n=19 Participants
25 Participants
n=36 Participants
Pathology
Benign
12 Participants
n=17 Participants
13 Participants
n=19 Participants
25 Participants
n=36 Participants
Pathology
Malignant
5 Participants
n=17 Participants
6 Participants
n=19 Participants
11 Participants
n=36 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Rectal Acetaminophen
n=17 Participants
Patients will receive two 650mg suppositories rectally of acetaminophen for a total dose of 1300mg at the end of surgery. Rectal acetaminophen: Rectal 1300mg
Intravenous Acetaminophen
n=19 Participants
Patients will receive one dose of 1000mg of acetaminophen, administered intravenously, at the end of surgery. Intravenous acetaminophen: Intravenous 1000mg
Postoperative Pain: Standardized Pain Scale
2.82 score on a scale
Standard Deviation 1.11
3.18 score on a scale
Standard Deviation 1.26

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Rectal Acetaminophen
n=17 Participants
Patients will receive two 650mg suppositories rectally of acetaminophen for a total dose of 1300mg at the end of surgery. Rectal acetaminophen: Rectal 1300mg
Intravenous Acetaminophen
n=19 Participants
Patients will receive one dose of 1000mg of acetaminophen, administered intravenously, at the end of surgery. Intravenous acetaminophen: Intravenous 1000mg
Opioid Use
25.75 Morphine Milligram Equivalents
Standard Deviation 20.09
23.71 Morphine Milligram Equivalents
Standard Deviation 18.46

OTHER_PRE_SPECIFIED outcome

Timeframe: The first 6 hours following surgery

Population: Two participants in the intravenous acetaminophen group were discharged home prior to 6 hours after surgery and therefore were not included in the analysis.

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.

Outcome measures

Outcome measures
Measure
Rectal Acetaminophen
n=17 Participants
Patients will receive two 650mg suppositories rectally of acetaminophen for a total dose of 1300mg at the end of surgery. Rectal acetaminophen: Rectal 1300mg
Intravenous Acetaminophen
n=17 Participants
Patients will receive one dose of 1000mg of acetaminophen, administered intravenously, at the end of surgery. Intravenous acetaminophen: Intravenous 1000mg
Postoperative Pain: Standardized Pain Scale
3.13 score on a scale
Standard Deviation 1.36
1.36 score on a scale
Standard Deviation 1.78

OTHER_PRE_SPECIFIED outcome

Timeframe: The 12 hours following surgery

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Rectal Acetaminophen
n=16 Participants
Patients will receive two 650mg suppositories rectally of acetaminophen for a total dose of 1300mg at the end of surgery. Rectal acetaminophen: Rectal 1300mg
Intravenous Acetaminophen
n=16 Participants
Patients will receive one dose of 1000mg of acetaminophen, administered intravenously, at the end of surgery. Intravenous acetaminophen: Intravenous 1000mg
Postoperative Pain: Standardized Pain Scale
2.99 score on a scale
Standard Deviation 1.20
3.36 score on a scale
Standard Deviation 1.43

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
Rectal Acetaminophen
n=17 Participants
Patients will receive two 650mg suppositories rectally of acetaminophen for a total dose of 1300mg at the end of surgery. Rectal acetaminophen: Rectal 1300mg
Intravenous Acetaminophen
n=17 Participants
Patients will receive one dose of 1000mg of acetaminophen, administered intravenously, at the end of surgery. Intravenous acetaminophen: Intravenous 1000mg
Opioid Use
6.74 Morphine Milligram Equivalents
Standard Deviation 7.49
7.97 Morphine Milligram Equivalents
Standard Deviation 6.28

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
Rectal Acetaminophen
n=16 Participants
Patients will receive two 650mg suppositories rectally of acetaminophen for a total dose of 1300mg at the end of surgery. Rectal acetaminophen: Rectal 1300mg
Intravenous Acetaminophen
n=16 Participants
Patients will receive one dose of 1000mg of acetaminophen, administered intravenously, at the end of surgery. Intravenous acetaminophen: Intravenous 1000mg
Opioid Use
15.52 Morphine Milligram Equivalents
Standard Deviation 13.35
14.17 Morphine Milligram Equivalents
Standard Deviation 11.87

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
Rectal Acetaminophen
n=17 Participants
Patients will receive two 650mg suppositories rectally of acetaminophen for a total dose of 1300mg at the end of surgery. Rectal acetaminophen: Rectal 1300mg
Intravenous Acetaminophen
n=19 Participants
Patients will receive one dose of 1000mg of acetaminophen, administered intravenously, at the end of surgery. Intravenous acetaminophen: Intravenous 1000mg
Estimated Blood Loss
273.53 Millilitres
Standard Deviation 138.20
347.37 Millilitres
Standard Deviation 75.41

OTHER_PRE_SPECIFIED outcome

Timeframe: From the start to end of the surgery

Operative time in minutes determined by the operating room record

Outcome measures

Outcome measures
Measure
Rectal Acetaminophen
n=17 Participants
Patients will receive two 650mg suppositories rectally of acetaminophen for a total dose of 1300mg at the end of surgery. Rectal acetaminophen: Rectal 1300mg
Intravenous Acetaminophen
n=19 Participants
Patients will receive one dose of 1000mg of acetaminophen, administered intravenously, at the end of surgery. Intravenous acetaminophen: Intravenous 1000mg
Operative Time
88.71 Minutes
Standard Deviation 24.22
90.89 Minutes
Standard Deviation 21.97

Adverse Events

Rectal Acetaminophen

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Intravenous 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

Dr. Michaela Beynon

Aultman Hospital

Phone: 2488218826

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place