Skip to main content
OpenTrials
Completed

NCT Number: NCT04175509

Improving Post-Operative Pain and Recovery in Gynecologic Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Aultman Hospital

Canton, Ohio, 44710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rectal acetaminophen

Drug

Rectal 1300mg

Intravenous acetaminophen

Drug

Intravenous 1000mg

Primary outcomes

  1. Postoperative Pain: Standardized Pain Scale

    Time frame: 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 outcomes

  1. Opioid Use

    Time frame: 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 outcomes

  1. Postoperative Pain: Standardized Pain Scale

    Time frame: 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.

  2. Postoperative Pain: Standardized Pain Scale

    Time frame: 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.

  3. Opioid Use

    Time frame: 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

  4. Opioid Use

    Time frame: 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

  5. Estimated Blood Loss

    Time frame: 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

  6. Operative Time

    Time frame: From the start to end of the surgery

    Operative time in minutes determined by the operating room record

Sponsors and collaborators

Lead sponsor

Aultman Health Foundation

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 25, 2019
Registry last updated
Jan 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.