NCT04175509

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_4 postoperative-pain

Timeline
Completed

Started Dec 2019

Typical duration for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 25, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

December 23, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
3 months until next milestone

Results Posted

Study results publicly available

August 19, 2021

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

1.4 years

First QC Date

November 21, 2019

Results QC Date

June 4, 2021

Last Update Submit

January 18, 2022

Conditions

Postoperative PainOpioid UseAcetaminophen

Keywords

Postoperative PainMinimally-invasive HysterectomyOpioid UseAcetaminophenHysterectomy

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (1)

  • Opioid Use

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

Other Outcomes (6)

  • Postoperative Pain: Standardized Pain Scale

    The first 6 hours following surgery

  • Postoperative Pain: Standardized Pain Scale

    The 12 hours following surgery

  • Opioid Use

    The first 6 hours following surgery

  • +3 more other outcomes

Study Arms (2)

Rectal acetaminophen

ACTIVE COMPARATOR

Patients will receive two 650mg suppositories rectally of acetaminophen for a total dose of 1300mg at the end of surgery.

Drug: Rectal acetaminophen

Intravenous acetaminophen

ACTIVE COMPARATOR

Patients will receive one dose of 1000mg of acetaminophen, administered intravenously, at the end of surgery.

Drug: Intravenous acetaminophen

Interventions

Rectal acetaminophenDRUG

Rectal 1300mg

Rectal acetaminophen
Intravenous acetaminophenDRUG

Intravenous 1000mg

Intravenous acetaminophen

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aultman Hospital

Canton, Ohio, 44710, United States

Location

Related Publications (6)

  • Cao X, et al. Effect of intraoperative or postoperative intravenous acetaminophen on postoperative pain scores and opioid requirements in abdominal and spinal surgery patients. Int J Clin Exp Med 11(4)4120-4125, 2018.

    BACKGROUND

  • Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.

    PMID: 26827847BACKGROUND

  • Sconzo Jr FR, Ramamoorthy S. The role of multimodal analgesia in colorectal surgery: a review of clinical data and case-based presentations featuring Ofirmev (acetaminophen) injections. Diseases of the Colon & Rectum 58(2):1-15, 2015.

    BACKGROUND

  • Jibril F, Sharaby S, Mohamed A, Wilby KJ. Intravenous versus Oral Acetaminophen for Pain: Systematic Review of Current Evidence to Support Clinical Decision-Making. Can J Hosp Pharm. 2015 May-Jun;68(3):238-47. doi: 10.4212/cjhp.v68i3.1458.

    PMID: 26157186BACKGROUND

  • Petterson PH, Hein A, Owall A, Anderson RE, Jakobsson JG. Early bioavailability in day surgery: a comparison between orally, rectally, and intravenously administered paracetamol. J. of Ambulatory Surgery 12:27-30, 2005.

    BACKGROUND

  • Cobby TF, Crighton IM, Kyriakides K, Hobbs GJ. Rectal paracetamol has a significant morphine-sparing effect after hysterectomy. Br J Anaesth. 1999 Aug;83(2):253-6. doi: 10.1093/bja/83.2.253.

    PMID: 10618939BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Limitations and Caveats

Due to the COVID-19 pandemic, many patients were prohibited to stay overnight in the hospital. Therefore, many patients were discharged home before 24 hours after surgery. This is primarily why the primary and secondary outcomes were analyzed at shorter time intervals (6 hours post-op and 12 hours-op) as well.

Results Point of Contact

Title
Dr. Michaela Beynon
Organization
Aultman Hospital
michaelabeynon@gmail.com
2488218826

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 21, 2019

First Posted

November 25, 2019

Study Start

December 23, 2019

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

January 20, 2022

Results First Posted

August 19, 2021

Record last verified: 2022-01

Locations

US(1)