A Phase 4 interventional study of Rectal acetaminophen and Intravenous acetaminophen in Postoperative Pain, Opioid Use and Acetaminophen, sponsored by Aultman Health Foundation. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-20.
Sponsored by Aultman Health Foundation · Phase 4, Interventional, and Supportive care
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.
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.
This study's enrollment of 40 is below the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Aultman Health Foundation is the lead sponsor of 13 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive two 650mg suppositories rectally of acetaminophen for a total dose of 1300mg at the end of surgery.
Drug: Rectal acetaminophen
Patients will receive one dose of 1000mg of acetaminophen, administered intravenously, at the end of surgery.
Drug: Intravenous acetaminophen
Rectal 1300mg
Intravenous 1000mg
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.
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.
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
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
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
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
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
Operative Time
Operative time in minutes determined by the operating room record
Time frame: From the start to end of the surgery
| Milestone | Rectal Acetaminophen | Intravenous Acetaminophen |
|---|---|---|
| Started | 19 | 21 |
| Completed | 17 | 19 |
| Not completed | 2 | 2 |
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.
| score on a scale | Rectal Acetaminophen | Intravenous Acetaminophen |
|---|---|---|
| Postoperative Pain: Standardized Pain Scale | 2.82 ± 1.11 | 3.18 ± 1.26 |
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.
| Morphine Milligram Equivalents | Rectal Acetaminophen | Intravenous Acetaminophen |
|---|---|---|
| Opioid Use | 25.75 ± 20.09 | 23.71 ± 18.46 |
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.
| score on a scale | Rectal Acetaminophen | Intravenous Acetaminophen |
|---|---|---|
| Postoperative Pain: Standardized Pain Scale | 3.13 ± 1.36 | 1.36 ± 1.78 |
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.
| score on a scale | Rectal Acetaminophen | Intravenous Acetaminophen |
|---|---|---|
| Postoperative Pain: Standardized Pain Scale | 2.99 ± 1.20 | 3.36 ± 1.43 |
Total amount of opioid rescue calculated by converting all opiates to Morphine Milligram Equivalents in the first 6 hours following surgery
| Morphine Milligram Equivalents | Rectal Acetaminophen | Intravenous Acetaminophen |
|---|---|---|
| Opioid Use | 6.74 ± 7.49 | 7.97 ± 6.28 |
Total amount of opioid rescue calculated by converting all opiates to Morphine Milligram Equivalents in the first 12 hours following surgery
| Morphine Milligram Equivalents | Rectal Acetaminophen | Intravenous Acetaminophen |
|---|---|---|
| Opioid Use | 15.52 ± 13.35 | 14.17 ± 11.87 |
Total estimated blood loss in millilitres for the surgery
| Millilitres | Rectal Acetaminophen | Intravenous Acetaminophen |
|---|---|---|
| Estimated Blood Loss | 273.53 ± 138.20 | 347.37 ± 75.41 |
Operative time in minutes determined by the operating room record
| Minutes | Rectal Acetaminophen | Intravenous Acetaminophen |
|---|---|---|
| Operative Time | 88.71 ± 24.22 | 90.89 ± 21.97 |
Collected over From administration of acetaminophen until discharge from the hospital, up to 24 hours.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rectal Acetaminophen | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Intravenous Acetaminophen | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| Age, Categorical(Participants) | Rectal Acetaminophen | Intravenous Acetaminophen | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 17 | 31 |
| >=65 years | 3 | 2 | 5 |
| Age, Continuous(years) | Rectal Acetaminophen | Intravenous Acetaminophen | Total |
|---|---|---|---|
| Mean | 50.53 ± 13.64 | 52.37 ± 14.08 | 51.50 ± 13.70 |
| Sex: Female, Male(Participants) | Rectal Acetaminophen | Intravenous Acetaminophen | Total |
|---|---|---|---|
| Female | 17 | 19 | 36 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Rectal Acetaminophen | Intravenous Acetaminophen | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Rectal Acetaminophen | Intravenous Acetaminophen | Total |
|---|---|---|---|
| United States | 17 | 19 | 36 |
| Indication for hysterectomy(Participants) | Rectal Acetaminophen | Intravenous Acetaminophen | Total |
|---|---|---|---|
| Benign | 11 | 12 | 23 |
| Malignant | 6 | 7 | 13 |
| Diabetes Mellitus(Participants) | Rectal Acetaminophen | Intravenous Acetaminophen | Total |
|---|---|---|---|
| Count of participants | 4 | 1 | 5 |
| Hypertension(Participants) | Rectal Acetaminophen | Intravenous Acetaminophen | Total |
|---|---|---|---|
| Count of participants | 10 | 7 | 17 |
5 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Aultman Health Foundation