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IV Acetaminophen for Post-Operative Pain Management in Enhanced Recovery After Surgery (ERAS) Population

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ClinicalTrials.gov Identifier: NCT03198871
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : June 5, 2018
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Kathirvel Subramaniam, University of Pittsburgh

Brief Summary:
Number of patients with unsatisfactory pain relief defined as average visual analog scale (VAS) more than 5 with or without requirement of IVPCA for pain relief during the first 48 hours postoperative period will be compared between the two groups and form the primary outcome for the study. Postoperative pain intensity will be measured by Visual Analog Scale (VAS) with 0- being no pain and 10-being maximum pain and the analgesic efficacy in both groups will also be evaluated by the amount of total narcotic consumption (measured with IV morphine equivalent doses of analgesics used to provide pain relief).

Condition or disease Intervention/treatment Phase
Abdominal Wall Hernia Pancreatic Diseases Bowel Disease Gastric Disease Drug: Acetaminophen Injectable Product Drug: Sodium Chloride 0.9%, Intravenous Phase 4

Detailed Description:
In response to an increased focus on improving patient outcomes and satisfaction with surgical care, a growing body of clinical evidence has recently been dedicated to enhanced recovery after surgery (ERAS) protocols. These evidence-based perioperative pathways aim to optimize patients undergoing surgery in the preoperative, intraoperative, and postoperative periods. ERAS protocols have incorporated the use of multimodal analgesia to minimize the use of intra- and postoperative opioid analgesics. Lidocaine, ketamine, magnesium, gabapentin, acetaminophen and non-steroidal anti-inflammatory drugs are some of the adjuvant analgesics used in combination with regional blocks to optimize analgesia and recovery. Multimodal analgesia has dependably been shown to significantly reduce postoperative opioid requirements as well as opioid-related side effects such as postoperative nausea and vomiting. Both oral and intravenous acetaminophen preparations have been shown to be useful adjuvants in multimodal analgesia. Intravenous acetaminophen has been of interest for its utility in post-surgical patients, who have not yet been cleared for oral intake. Intravenous acetaminophen should also be preferred over oral acetaminophen in patients after major abdominal surgery where absorption of medications given through oral route is erratic. Although the efficacy of intravenous acetaminophen as a postoperative pain adjunct is known, its exact role in ERAS protocols and non-narcotic multimodal analgesic regimens for major abdominal surgery has not been studied in randomized clinical trials to define its efficacy. The primary goal of this study is to assess the utility of a postoperative intravenous acetaminophen dosing schedule in minimizing postoperative pain, opioid consumption and opioid-related side effects. We also aim to study overall patient satisfaction and cost-effectiveness (direct and indirect costs) of this regimen as part of ERAS protocol at a large tertiary medical center.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participant, care provider, outcomes assessor and investigator are all blinded to the treatment allocation
Primary Purpose: Treatment
Official Title: Role of Scheduled Intravenous Acetaminophen for Postoperative Pain Management in an Enhanced Recovery After Surgery (ERAS) Population: A Prospective, Randomized, Double-Blind and Placebo-Controlled Clinical Trial
Actual Study Start Date : May 24, 2018
Estimated Primary Completion Date : March 15, 2019
Estimated Study Completion Date : August 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acetaminophen Injectable Product
Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group
Drug: Acetaminophen Injectable Product
The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively
Other Names:
  • Tylenol
  • Paracetamol
  • Ofirmev

Placebo Comparator: Sodium Chloride 0.9%, Intravenous
Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group
Drug: Sodium Chloride 0.9%, Intravenous
The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
Other Name: Saline




Primary Outcome Measures :
  1. Postoperative Pain Intensity [ Time Frame: PACU admission every thirty minutes until discharge to the floor and thereafter every four hours for first 24-hour, then every six hours until 48 hours and then every twelve hours until 72 hours postoperatively. ]
    Number of patients with unsatisfactory pain relief defined as average numeric rating scale (NRS) more than 5 will be compared between the two groups. This may include patients using IVPCA for pain relief during the first 48 hours postoperative.


Secondary Outcome Measures :
  1. Total post-operative narcotic consumption [ Time Frame: From time of PACU admission until the time of discharge and 72-hours postoperatively, whichever comes first ]
    Rescue analgesia will be given according to institutional pain management protocol

  2. Time to readiness for discharge from post anesthesia care unit (PACU) [ Time Frame: From time of PACU admission until the time of discharge, assessed up to 24 hours postoperatively ]
    The time from PACU admission to PACU discharge to the floor will be measured.

  3. Time to bowel movement [ Time Frame: From date of randomization until the date of first documented bowel movement, assessed up 72 hour postoperatively ]
    The time it takes for the first bowel movement postoperatively will be measured.

  4. Time to oral intake [ Time Frame: From date of randomization until the date of first documented oral intake, assessed up to 72 hours postoperatively ]
    The time it takes for the patient to ingest orally post-surgery will be measured.

  5. Time to ambulation [ Time Frame: From date of PACU admission until the date of first documented ambulation, assessed up to 72 hours postoperatively ]
    The time it takes for the patient to successfully ambulate post-surgery will be measured.

  6. Time to hospital discharge [ Time Frame: From date of randomization until the date of hospital discharge or 30 days postoperatively, whichever comes first ]
    The time it takes for the patient to be fully discharged from the hospital post-surgery will be measured.

  7. Readmission to the hospital [ Time Frame: From the time of consent until 30 days post-operatively ]
    If the patient is readmitted to the hospital after being fully discharged, the even will be recorded.

  8. Patient Satisfaction [ Time Frame: These measurements will be taken at time of discharge up to 30 days, whichever comes first ]
    Overall patient satisfaction as well as satisfaction relating to pain management and cost analyses will be measured. These will be measured with a numerical rating scale with 0- being worst satisfaction and 10 - best satisfaction.

  9. Intensive Care Delirium Screening Checklist (ICDSC) [ Time Frame: The delirium scores will first be measured every 12 hours for 72 hours after surgery. ]
    The ICDSC will be used to assess delirium scores.

  10. Post-operative Nausea [ Time Frame: These will be evaluated from the time of PACU admission until 72 hours postoperatively. ]
    Nausea will be evaluated by nausea score (0-10)

  11. Post-operative Emesis [ Time Frame: These will be evaluated from the time of PACU admission until 72 hours postoperatively. ]
    Frequency of emesis and rescue antiemetic requirement will be documented

  12. SF-12 health survey [ Time Frame: These measurements will take place at 30-days post hospital discharge ]
    Survey to assess patient's overall health at 30 days post-discharge



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or Female
  • 18 years of age or older
  • patients scheduled for elective colorectal, pancreatic, and other major abdominal procedure.
  • Patient consent will be obtained preoperatively for eligible study participants.

Exclusion Criteria:

  • Patients who refuse to participate in the study or part of any other enhanced recovery after surgery (ERAS) research protocol.
  • Patients with a documented allergy to acetaminophen.
  • Chronic alcoholism
  • Hypovolemia
  • Chronic malnutrition
  • Preoperative renal insufficiency (creatinine clearance less than or equal to 30ml/min) or hemodialysis
  • Patients with a history of hepatic impairment, history of hepatic impairment or active hepatic disease
  • severe chronic pain condition that required daily preoperative opioid dependence
  • Patients with pre-existing dementia and/or other neuropsychiatric conditions impeding accurate assessment of pain scores or other study measures will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198871


Contacts
Contact: Amy Monroe 412-623-6382 Monroeal@upmc.edu
Contact: Caroline Kostishack 412-623-1586 caroline.kostishack@chp.edu

Locations
United States, Pennsylvania
Upmc Presbyterian Montefiore Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: KATHIRVEL SUBRAMANIAM, MD    412-647-5635    subramaniamk@upmc.edu   
Contact: AMY MONROE, MPH    4126096161    monroeal@upmc.edu   
Sponsors and Collaborators
Kathirvel Subramaniam
Mallinckrodt
Investigators
Principal Investigator: Kathirvel Subramaniam, M.D., M.P.H Associate Professor and staff Anesthesiologist

Publications:
Gonzalez A, Ziemann-Gimmel P. The role of multimodal analgesia in bariatric surgery: A review of clinical data and case-based presentations featuring OFIRMEV® (acetaminophen) injection. Surgical Pain Management. 2014;11(5): A2-11.

Responsible Party: Kathirvel Subramaniam, Principal Investigator, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03198871     History of Changes
Other Study ID Numbers: PRO17050418
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Kathirvel Subramaniam, University of Pittsburgh:
Post-operative pain
Major abdominal surgery
Colorectal surgery
Gastric surgery

Additional relevant MeSH terms:
Pancreatic Diseases
Pain, Postoperative
Hernia, Ventral
Stomach Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Digestive System Diseases
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical
Gastrointestinal Diseases
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics