Effect of Intravenous Acetaminophen on Postoperative Opioid-related Complications

NCT02156154 | Completed Phase 3 Results

• 1 other identifier: 14-241
• Study Type: interventional
• Target: 580
• Locations: 1 country
• Sites: 1

Brief Summary

Some patients have respiratory depression (decreased breaths per minute) after surgery. Acetaminophen, an FDA approved pain medication, may prevent this problem. The purpose of this study is to determine if acetaminophen decreases respiratory depression after surgery. The investigators will also evaluate the cost effectiveness of acetaminophen. Patients having elective major abdominal surgery are being asked to participate in this research study. If eligible, a patient will have their baseline tidal volume (amount of air moved into or out of the lungs) and vital capacity (how much air the lungs are capable of holding) measured using a spirometer (apparatus for measuring the volume of air inspired and expired by the lungs) measured before surgery. Three questionnaires will also need to be completed before surgery. The patient will then be randomized, like flipping a coin, to receive either Acetaminophen or placebo (inactive substance) as an infusion throughout surgery and for the first two days thereafter. Neither the patient nor his or her physician will know if the patient is assigned to study drug or placebo. Regardless of study assignment, both groups will receive standard pain management medications and sedation. After surgery, the patient's blood pressure, activity, posture, respiratory rate, the electrical activity of the heart, oxygen saturation, tidal volume, minute ventilation and respiratory rate will be continuously monitored and recorded for 48 hours using a wireless pulse-oximeter and a respiratory volume monitor. 48 hours after surgery the patient will be asked to complete a patient satisfaction questionnaire, which will allow the patient to rate the satisfaction with the treatment received for pain. The patient will also be asked to complete a questionnaire about recovery. At discharge, the patient will be given two questionnaires about pain and quality of life.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Duration of Hypoxemia

  Hypoxemia is measured as minutes with hypoxemia (Spo2 \<90%) per hour of successful Spo2 monitoring. Patients will have nearly continuous pulseoximeter monitoring and recording. Data from the monitor will be downloaded daily for 48 hours postoperatively.

  the initial 48 hours of postoperative monitoring or for the duration of hospitalization, if shorter.

Secondary Outcomes (9)

• Time-weighted Pain Score During Initial 48 Postoperative Hours

  Initial 48 postoperative hours or duration of hospitalization (whichever comes first)

• Time Weighted Pain Score in Post Anesthesia Care Unit

  Initial 48 postoperative hours or duration of hospitalization (whichever comes first)

• Fatigue Score on Morning of Postoperative Day 1

  Postoperative day 1

• Lowest RASS Score During Initial 48 Postoperative Hours

  Initial 48 postoperative hours or duration of hospitalization (whichever comes first)

• Time Spent in Sitting or Upright Position

  Initial 48 postoperative hours or duration of hospitalization (whichever comes first)

Study Arms (2)

Intravenous 0.9% sodium chloride

PLACEBO COMPARATOR

0.9% sodium chloride infusion will be initiated before the surgical incision with 100 ml and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge.

Drug: Intravenous Acetaminophen

Intravenous Acetaminophen

EXPERIMENTAL

Acetaminophen infusion will be initiated before the surgical incision with 1 g and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge.

Drug: Intravenous Acetaminophen

Interventions

Intravenous Acetaminophen DRUG

Intravenous 0.9% sodium chloride; Intravenous Acetaminophen

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• years old
• above 50 kg
• American Society of Anaesthesiologists Physical Status 1-3
• Scheduled for elective open or laparoscopic abdominal surgery, including colorectal, prostate, and hysterectomy surgeries
• Patients with anticipated hospitalization of two nights
• Expected to require parenteral opioids for at least 48 hours for postoperative pain
• Able to use IV Patient-Controlled Analgesia systems

You may not qualify if:

• Hepatic disease, e.g. twice the normal levels of liver enzymes
• Kidney disease, e.g. twice the normal level of serum creatinine
• Epidural analgesia or regional blocks (including Transverse abdominis plane block)
• Acetaminophen sensitivity or known allergy
• Female patients who are pregnant or breastfeeding
• Patients taking warfarin

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Turan A, Essber H, Saasouh W, Hovsepyan K, Makarova N, Ayad S, Cohen B, Ruetzler K, Soliman LM, Maheshwari K, Yang D, Mascha EJ, Ali Sakr Esa W, Kessler H, Delaney CP, Sessler DI; FACTOR Study Group. Effect of Intravenous Acetaminophen on Postoperative Hypoxemia After Abdominal Surgery: The FACTOR Randomized Clinical Trial. JAMA. 2020 Jul 28;324(4):350-358. doi: 10.1001/jama.2020.10009.

  PMID: 32721009 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Alparslan Turan, MD
• Organization: Cleveland Clinic

turana@ccf.org

216-445-0998

Study Officials

• Alparslan Turan, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Staff Anesthesiologist

Study Record Dates

• First Submitted: June 3, 2014
• First Posted: June 5, 2014
• Study Start: December 1, 2014
• Primary Completion: March 1, 2019
• Study Completion: October 1, 2020
• Last Updated: April 20, 2021
• Results First Posted: April 20, 2021

Record last verified: 2021-03

Locations

US (1)