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Improving Post-Operative Pain and Recovery in Gynecologic Surgery

Improving Post-Operative Pain and Recovery in Gynecologic Surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04175509
Enrollment
40
Registered
2019-11-25
Start date
2019-12-23
Completion date
2021-06-01
Last updated
2022-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Opioid Use, Acetaminophen

Keywords

Postoperative Pain, Minimally-invasive Hysterectomy, Opioid Use, Acetaminophen, Hysterectomy

Brief summary

This is a clinical investigation to determine the efficacy of rectal versus intravenous acetaminophen in patients undergoing a minimally invasive hysterectomy. All women will receive acetaminophen either rectally or intravenously immediately postoperative, prior to extubation. Patient's will be randomly assigned to either the rectal acetaminophen or the intravenous acetaminophen group. Patient outcomes will be measured through a Numeric Rating Scale (NRS) from 0-10 for pain scores, and total opioid consumption measured in morphine milligram equivalent (MME) for the first 24 hours following surgery, or upon discharge, whichever comes first.

Detailed description

Patient's undergoing major gynecologic surgery require effective postoperative pain management in order to enhance recovery and ultimately allow patients to return to their preoperative functional state. Traditionally, acute postoperative pain control has been achieved largely with the use of opioid medications. Excessive use of opioids can have adverse effects on the recovery process. Side effects include, but are not limited to dizziness, sedation, nausea/vomiting, respiratory depression, euphoria, constipation, and abuse. In addition, opioid monotherapy can delay post-operative ambulation, contribute to prolonged hospital stay and resumption of activities of daily living, and furthermore, have long-term sequelae for individuals as well as society at whole. Over the past decade, a multimodal approach to pain management has been explored in attempts to optimally treat acute postoperative pain. This approach is one of the keys to improving the recovery process. Acetaminophen is a non-opioid analgesic with a well-established safety and tolerability profile that is commonly used in multimodal approach to treating surgical pain. It is available in oral, rectal and Intravenous (IV) formulation. IV acetaminophen in particular is increasingly used for pain control after surgery as it has demonstrated a significant analgesic benefit in a variety of surgery types by reduction in pain intensity while decreasing total opioid use. Many studies have evaluated the efficacy of acetaminophen based on route of administration. A systematic review demonstrated that there is no clear indication for intravenous acetaminophen for patients who can tolerate an oral dosage as there was no difference if efficacy outcomes. This is valuable information as the cost of IV acetaminophen is exponentially more than the oral form. Although the oral form of acetaminophen is as efficient as controlling pain when compared to IV, and is notably cheaper, it is not the best option for the nauseated patient or patients whom are restricted from oral intake following surgery. Rectal acetaminophen is therefore a feasible alternative option in such patients. Data on the use of rectal acetaminophen in adults for postoperative pain management is limited. Pettersson and colleagues (2005) compared oral, rectal and IV paracetamol in day surgery patients. Although they demonstrated significantly higher plasma paracetamol concentrations in patients who received oral and IV formations at multiple time points, there was no difference in pain ratings. In another study, rectal paracetamol was shown to have a significant morphine-sparing effect after hysterectomy. At this time, there has been no study in the gynecologic literature to compare IV to rectal acetaminophen in terms of pain control and effect on overall opioid use in the acute post-operative period. The rationale for this study is to determine the optimal way of managing post-operative pain in gynecologic surgery in attempt to improve the overall recovery process. More specifically, this study will determine if the route of administration of acetaminophen has an effect on post-operative pain and use of opioid medication following a minimally invasive hysterectomy. The results of this study may guide post-operative pain management after gynecologic surgery, and help limit the amount of opioid use, while potentially reducing pharmacological costs for patients and hospitals.

Interventions

DRUGRectal acetaminophen

Rectal 1300mg

Intravenous 1000mg

Sponsors

Aultman Health Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Willing to consent * Amendable to receive either rectal or intravenous acetaminophen * Planned hospital stay for at least 24 hours.

Exclusion criteria

* Patients unable to provide informed consent * Patients with a history of regular opioid use prior to surgery based on their current home medication list * Patients who have required regular opioid intake for the 7 days preceding surgery * Patients with known hypersensitivity to acetaminophen * Patients with a baseline preoperative liver function enzymes (AST and ALT) that are greater than twice the upper limits * Unable to complete procedure as planned.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pain: Standardized Pain ScaleThe 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

MeasureTime frameDescription
Opioid UseThe 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

MeasureTime frameDescription
Postoperative Pain: Standardized Pain ScaleThe first 6 hours following surgeryPost-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.
Opioid UseThe first 6 hours following surgeryTotal amount of opioid rescue calculated by converting all opiates to Morphine Milligram Equivalents in the first 6 hours following surgery
Estimated Blood LossDuring the duration of the surgery, from start to end time, on average 1.5 hoursTotal estimated blood loss in millilitres for the surgery
Operative TimeFrom the start to end of the surgeryOperative time in minutes determined by the operating room record

Countries

United States

Participant flow

Participants by arm

ArmCount
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
17
Intravenous Acetaminophen
Patients will receive one dose of 1000mg of acetaminophen, administered intravenously, at the end of surgery. Intravenous acetaminophen: Intravenous 1000mg
19
Total36

Baseline characteristics

CharacteristicIntravenous AcetaminophenRectal AcetaminophenTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
2 Participants3 Participants5 Participants
Age, Categorical
Between 18 and 65 years
17 Participants14 Participants31 Participants
Age, Continuous52.37 years
STANDARD_DEVIATION 14.08
50.53 years
STANDARD_DEVIATION 13.64
51.50 years
STANDARD_DEVIATION 13.7
Anxiety and/or depression5 Participants7 Participants12 Participants
Diabetes Mellitus1 Participants4 Participants5 Participants
Hypertension7 Participants10 Participants17 Participants
Indication for hysterectomy
Benign
12 Participants11 Participants23 Participants
Indication for hysterectomy
Malignant
7 Participants6 Participants13 Participants
Obesity14 Participants11 Participants25 Participants
Pathology
Benign
13 Participants12 Participants25 Participants
Pathology
Malignant
6 Participants5 Participants11 Participants
Pulmonary disease2 Participants5 Participants7 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
19 participants17 participants36 participants
Sex: Female, Male
Female
19 Participants17 Participants36 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
Thyroid disease2 Participants1 Participants3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 190 / 21
other
Total, other adverse events
0 / 190 / 21
serious
Total, serious adverse events
0 / 190 / 21

Outcome results

Primary

Postoperative Pain: Standardized Pain Scale

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.

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

ArmMeasureValue (MEAN)Dispersion
Rectal AcetaminophenPostoperative Pain: Standardized Pain Scale2.82 score on a scaleStandard Deviation 1.11
Intravenous AcetaminophenPostoperative Pain: Standardized Pain Scale3.18 score on a scaleStandard Deviation 1.26
p-value: 0.378t-test, 2 sided
Secondary

Opioid Use

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.

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

ArmMeasureValue (MEAN)Dispersion
Rectal AcetaminophenOpioid Use25.75 Morphine Milligram EquivalentsStandard Deviation 20.09
Intravenous AcetaminophenOpioid Use23.71 Morphine Milligram EquivalentsStandard Deviation 18.46
p-value: 0.753t-test, 2 sided
Other Pre-specified

Estimated Blood Loss

Total estimated blood loss in millilitres for the surgery

Time frame: During the duration of the surgery, from start to end time, on average 1.5 hours

ArmMeasureValue (MEAN)Dispersion
Rectal AcetaminophenEstimated Blood Loss273.53 MillilitresStandard Deviation 138.2
Intravenous AcetaminophenEstimated Blood Loss347.37 MillilitresStandard Deviation 75.41
p-value: 0.48t-test, 2 sided
Other Pre-specified

Operative Time

Operative time in minutes determined by the operating room record

Time frame: From the start to end of the surgery

ArmMeasureValue (MEAN)Dispersion
Rectal AcetaminophenOperative Time88.71 MinutesStandard Deviation 24.22
Intravenous AcetaminophenOperative Time90.89 MinutesStandard Deviation 21.97
p-value: 0.78t-test, 2 sided
Other Pre-specified

Opioid Use

Total amount of opioid rescue calculated by converting all opiates to Morphine Milligram Equivalents in the first 6 hours following surgery

Time frame: The first 6 hours following surgery

ArmMeasureValue (MEAN)Dispersion
Rectal AcetaminophenOpioid Use6.74 Morphine Milligram EquivalentsStandard Deviation 7.49
Intravenous AcetaminophenOpioid Use7.97 Morphine Milligram EquivalentsStandard Deviation 6.28
p-value: 0.61t-test, 2 sided
Other Pre-specified

Opioid Use

Total amount of opioid rescue calculated by converting all opiates to Morphine Milligram Equivalents in the first 12 hours following surgery

Time frame: The first 12 hours following surgery

ArmMeasureValue (MEAN)Dispersion
Rectal AcetaminophenOpioid Use15.52 Morphine Milligram EquivalentsStandard Deviation 13.35
Intravenous AcetaminophenOpioid Use14.17 Morphine Milligram EquivalentsStandard Deviation 11.87
p-value: 0.77t-test, 2 sided
Other Pre-specified

Postoperative Pain: Standardized Pain Scale

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Rectal AcetaminophenPostoperative Pain: Standardized Pain Scale2.99 score on a scaleStandard Deviation 1.2
Intravenous AcetaminophenPostoperative Pain: Standardized Pain Scale3.36 score on a scaleStandard Deviation 1.43
p-value: 0.43t-test, 2 sided
Other Pre-specified

Postoperative Pain: Standardized Pain Scale

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Rectal AcetaminophenPostoperative Pain: Standardized Pain Scale3.13 score on a scaleStandard Deviation 1.36
Intravenous AcetaminophenPostoperative Pain: Standardized Pain Scale1.36 score on a scaleStandard Deviation 1.78
p-value: 0.3t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026