IV Acetaminophen for Postoperative Pain Analgesia After Laparoscopic Hysterectomy

NCT02400580 | Completed Phase 4 Results DMC

• 1 other identifier: PRO13110403
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to quantify the change in post-operative pain scores and narcotic requirements in women receiving pre and post-operative IV acetaminophen compared to placebo in women undergoing laparoscopic hysterectomy.

Conditions

Pain

Keywords

Laparoscopic Hysterectomy; IV acetaminophen; Postoperative pain control; Surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain

  The primary aim of this study is to compare overall post-surgical pain after hysterectomy as reported by the patients on a visual analog scale with a range of 0 to 10 where 0 is no pain at all and 10 is the worst pain that a person can imagine. Less pain is considered preferable to more pain. The theory is that patients who have intravenous acetaminophen will report less post-surgical pain.

  24 hours

Secondary Outcomes (1)

• Narcotic Medication Use

  24 hours

Other Outcomes (4)

• Having a Feeling of General Well-being at One Month

  4 weeks

• Number of Participants Who Vomited Within 24 Hours of Operation

  24 hours

• Readiness for Discharge

  24 hours

Study Arms (2)

Intravenous IV acetaminophen

EXPERIMENTAL

The patients in the treatment arm will receive 1000mg of IV acetaminophen.

Drug: IV acetaminophen

Normal Saline

PLACEBO COMPARATOR

The patients in the placebo arm will receive normal saline.

Drug: placebo

Interventions

IV acetaminophen DRUG

The patients in the treatment arm will receive 1000mg of IV acetaminophen.

Also known as: OFIRMEV

Intravenous IV acetaminophen

placebo DRUG

The patients in the placebo arm will receive normal saline.

Also known as: Normal saline

Normal Saline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18-75
• Ability to read and write in English (our post-operative pain log is only available in English)
• Planning a laparoscopic hysterectomy (includes total laparoscopic hysterectomy, laparoscopic supracervical hysterectomy, laparoscopically assisted vaginal hysterectomy, with or without salpingooophorectomy)

You may not qualify if:

• Answering yes to any of the following questions: "Do you have a history of liver disease, kidney disease, hepatitis C, history of liver failure, greater than 3 drinks per day or being have you ever been told by your doctor that they should not take acetaminophen"
• History of cardiac arrhythmia
• History of jaundice
• Acute abdominal inflammatory or infectious process at time of surgery
• Known malignancy at time of surgery
• Known pregnancy at time of surgery
• Plan to perform additional significant surgical procedure at the time of hysterectomy such as extensive excision of endometriosis on bowel or bladder or pelvic reconstructive procedure
• \>6cm abdominal incision in order to remove the uterus at time of study-related hysterectomy
• Regular use of narcotic pain medication (defined as use on most days of the week at any point in the past 3 months)
• Allergy to acetaminophen
• Women who weigh less than 50 kilograms on the day of surgery.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Gonzalez AM, Romero RJ, Ojeda-Vaz MM, Rabaza JR. Intravenous acetaminophen in bariatric surgery: effects on opioid requirements. J Surg Res. 2015 May 1;195(1):99-104. doi: 10.1016/j.jss.2015.01.004. Epub 2015 Jan 14.

  PMID: 25680474 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

The original protocol involved 154 patients with an expected rate of loss to follow up of 10%. Due to higher than expected loss to follow up the number of patients enrolled was increased to 190.

Results Point of Contact

• Title: Dr. Noah Rindos
• Organization: University of Pittsburgh Medical Center

rindosnb@upmc.edu

(412) 641-8769

Study Officials

• Noah Rindos, MD

  Faculty

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow in Minimally Invasive Gynecology

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: March 27, 2015
• Study Start: February 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: June 13, 2018
• Results First Posted: December 21, 2017

Record last verified: 2018-05

Locations

US (1)