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Comparing Effectiveness of IV vs Oral Acetaminophen Given Perioperatively for Lap Choles for Pain Control,

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Defense and Veterans Center for Integrative Pain Management
ClinicalTrials.gov Identifier:
NCT01823224
First received: March 29, 2013
Last updated: May 5, 2016
Last verified: May 2016
  Purpose
The purpose of the study is to learn whether perioperative IV (intravenous) administration of acetaminophen (commonly referred to as Tylenol) shows any different clinical outcomes over the oral (by mouth) administration of acetaminophen for a patient having a laparoscopic cholecystectomy. If improved pain scores occur with the administration of IV acetaminophen, it may result in fewer requests for pain-related intervention such as other oral pain medications.

Condition Intervention
Laparoscopic Cholecystectomy
Drug: 2 capsules Oral Tylenol 2000 mg and IV "salt water"
Drug: IV tylenol 1000mg and 2 oral capsule "sugar pills"

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
Official Title: A Prospective, Randomized, Double Blind, Comparative-effectiveness Study Comparing Perioperative Administration of Oral Versus Intravenous Acetaminophen for Laparoscopic Cholecystectomy

Resource links provided by NLM:


Further study details as provided by Defense and Veterans Center for Integrative Pain Management:

Primary Outcome Measures:
  • Pain [ Time Frame: 24 hours after discharge ] [ Designated as safety issue: No ]
    Pain after treatment with IV versus oral tylenol will be assessed via pain scores utilizing an numerical rating scale (NRS) )0-10 with 0 as no pain and 10 as worst pain with 5 as moderate pain and faces accompanied the scores with full smile on no pain to tears and frown on worst pain.


Secondary Outcome Measures:
  • Total Opioid Consumption From Time of First Waking to T24 [ Time Frame: every 6 hours for 24 hours ] [ Designated as safety issue: No ]

    Pain diary will be filled out every 6 hours for 24 hours after discharge in which the following will be recorded:

    • Opioid consumption from first waking to T4
    • Total opioid consumption from T0 to T4
    • Total opioid consumption from time of first waking to T24


Enrollment: 67
Study Start Date: February 2013
Study Completion Date: September 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Group 1 will receive IV acetaminophen 1000mg plus 2 oral capsules "sugar pills" 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses of acetaminophen totaling or equaling 2000mg
Drug: IV tylenol 1000mg and 2 oral capsule "sugar pills"
IV acetaminophen 1000mg and 2 oral capsule "sugar pills were given to participants that were randomized to receive the IV acetaminophen. The same collection of pain scores and morphine equivalents was completed the same as the other group.
Other Name: Acetaminophen is comercially referred to as Tylenol.
Experimental: Group 2
Group 2 will receive an IV "salt water" infusion plus 2 capsules of oral acetaminophen 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses totaling or equaling 2000mg.
Drug: 2 capsules Oral Tylenol 2000 mg and IV "salt water"
The participants randomized to receive the '2 capsules Oral Acetaminophen 500 mg and IV "salt water repeated 4 hours after that dose to equal 2000mg. A pre-op pain score was obtained and pain scores every 15 min x 1 hour then per recovery routine and they did a 24 hour home diary to record pain scores for 24 hours post surgery. Their opioid morphine equivalent was recorded intraoperatively, recovery and at home. This was compared to the other group receiving IV acetaminophen.and the pain scores and morphine equivalents were collected the same as in the comparative group. Each group received a placebo version oral or iv accordingly.
Other Name: Acetaminophen is comercially referred to as Tylenol.

Detailed Description:

Subjects were enrolled following the listed inclusion and exclusion criteria.

Subjects Eligibility Criteria:

Inclusion Criteria:

Male and female patients ASA I - III . 18 years of age and older

Exclusion Criteria:

Chronic pain syndromes (pain symptoms lasting greater than 3 months), previous abdominal surgery Chronic home narcotic use (patient-reported narcotic use for greater than 3 months) Previous Bowel resection, colon surgery, stomach surgery

. Liver disease (AST or ALT greater than 3 times upper limit of normal), on labs closest to surgical date or within 6 months prior to surgery

Severe renal disease (creatinine clearance less than 30 mL/min), on labs closest to surgical date or within 6 months prior to surgery

Open or emergency surgery (non-scheduled surgery, surgery that must be performed within 6 hours for this particular surgery)

Prior NSAIDS (Non-Steroid Anti-inflammatory Drugs) including COX-2 agents use within the last 24 hours

Use of intraoperative NSAIDs

Contraindication to study drug (including allergic reaction or hypersensitivity to acetaminophen or any of its components;

Taking a medication with known interactions with acetaminophen

Taking chronic oral acetaminophen, greater than 6 months on a daily basis at a dose greater than 3000mg/day

Pregnancy

Current or past alcohol abuse (within the past 2 years)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients ASA I - III (A system used by anesthesiologists to stratify severity of patients' underlying disease and potential for suffering complications from general anesthesia ), 18 years of age and older
  • Patient must be scheduled for laparoscopic cholecystectomy

Exclusion Criteria:

  • Chronic pain syndromes (pain symptoms lasting greater than 3 months), previous abdominal surgery
  • Chronic home narcotic use (patient-reported narcotic use for greater than 3 months)
  • Liver disease (AST or ALT greater than 3 times upper limit of normal), on labs closest to surgical date or within 6 months prior to surgery
  • Severe renal disease (creatinine clearance less than 30 mL/min), on labs closest to surgical date or within 6 months prior to surgery
  • Open or emergency surgery (non-scheduled surgery, surgery that must be performed within 6 hours for this particular surgery)
  • Prior NSAIDS(Non-Steroid Anti-inflammatory Drugs) including COX-2 agents use within the last 24 hours
  • Use of intraoperative NSAIDs
  • Contraindication to study drug (including allergic reaction or hypersensitivity to acetaminophen or any of its components;
  • On a medication with known interactions with acetaminophen
  • On chronic oral acetaminophen, greater than 6 months on a daily basis at a dose greater than 3000mg/day
  • Pregnancy
  • Current or past alcohol abuse (within the past 2 years)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01823224

Locations
United States, North Carolina
Womack Army Medical Center
Fort Bragg, North Carolina, United States, 28310
Sponsors and Collaborators
Defense and Veterans Center for Integrative Pain Management
Investigators
Principal Investigator: Anthony R Plunkett, MD Womack Army Medical Center
  More Information

Responsible Party: Defense and Veterans Center for Integrative Pain Management
ClinicalTrials.gov Identifier: NCT01823224     History of Changes
Other Study ID Numbers: 380250 
Study First Received: March 29, 2013
Results First Received: October 2, 2015
Last Updated: May 5, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics

ClinicalTrials.gov processed this record on September 23, 2016