Postoperative Pain, Opioid Use, Acetaminophen
Conditions
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
Rectal 1300mg
Intravenous 1000mg
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
| Operative Time | From the start to end of the surgery | Operative time in minutes determined by the operating room record |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 36 |
Baseline characteristics
| Characteristic | Intravenous Acetaminophen | Rectal Acetaminophen | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 14 Participants | 31 Participants |
| Age, Continuous | 52.37 years STANDARD_DEVIATION 14.08 | 50.53 years STANDARD_DEVIATION 13.64 | 51.50 years STANDARD_DEVIATION 13.7 |
| Anxiety and/or depression | 5 Participants | 7 Participants | 12 Participants |
| Diabetes Mellitus | 1 Participants | 4 Participants | 5 Participants |
| Hypertension | 7 Participants | 10 Participants | 17 Participants |
| Indication for hysterectomy Benign | 12 Participants | 11 Participants | 23 Participants |
| Indication for hysterectomy Malignant | 7 Participants | 6 Participants | 13 Participants |
| Obesity | 14 Participants | 11 Participants | 25 Participants |
| Pathology Benign | 13 Participants | 12 Participants | 25 Participants |
| Pathology Malignant | 6 Participants | 5 Participants | 11 Participants |
| Pulmonary disease | 2 Participants | 5 Participants | 7 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 19 participants | 17 participants | 36 participants |
| Sex: Female, Male Female | 19 Participants | 17 Participants | 36 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Thyroid disease | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 21 |
| other Total, other adverse events | 0 / 19 | 0 / 21 |
| serious Total, serious adverse events | 0 / 19 | 0 / 21 |
Outcome results
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rectal Acetaminophen | Postoperative Pain: Standardized Pain Scale | 2.82 score on a scale | Standard Deviation 1.11 |
| Intravenous Acetaminophen | Postoperative Pain: Standardized Pain Scale | 3.18 score on a scale | Standard Deviation 1.26 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rectal Acetaminophen | Opioid Use | 25.75 Morphine Milligram Equivalents | Standard Deviation 20.09 |
| Intravenous Acetaminophen | Opioid Use | 23.71 Morphine Milligram Equivalents | Standard Deviation 18.46 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rectal Acetaminophen | Estimated Blood Loss | 273.53 Millilitres | Standard Deviation 138.2 |
| Intravenous Acetaminophen | Estimated Blood Loss | 347.37 Millilitres | Standard Deviation 75.41 |
Operative Time
Operative time in minutes determined by the operating room record
Time frame: From the start to end of the surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rectal Acetaminophen | Operative Time | 88.71 Minutes | Standard Deviation 24.22 |
| Intravenous Acetaminophen | Operative Time | 90.89 Minutes | Standard Deviation 21.97 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rectal Acetaminophen | Opioid Use | 6.74 Morphine Milligram Equivalents | Standard Deviation 7.49 |
| Intravenous Acetaminophen | Opioid Use | 7.97 Morphine Milligram Equivalents | Standard Deviation 6.28 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rectal Acetaminophen | Opioid Use | 15.52 Morphine Milligram Equivalents | Standard Deviation 13.35 |
| Intravenous Acetaminophen | Opioid Use | 14.17 Morphine Milligram Equivalents | Standard Deviation 11.87 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rectal Acetaminophen | Postoperative Pain: Standardized Pain Scale | 2.99 score on a scale | Standard Deviation 1.2 |
| Intravenous Acetaminophen | Postoperative Pain: Standardized Pain Scale | 3.36 score on a scale | Standard Deviation 1.43 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rectal Acetaminophen | Postoperative Pain: Standardized Pain Scale | 3.13 score on a scale | Standard Deviation 1.36 |
| Intravenous Acetaminophen | Postoperative Pain: Standardized Pain Scale | 1.36 score on a scale | Standard Deviation 1.78 |