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

A Prospective, Randomized, Double Blind, Comparative-effectiveness Study Comparing Perioperative Administration of Oral Versus Intravenous Acetaminophen for Laparoscopic Cholecystectomy

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Cholecystectomy
• Intervention / Treatment: Drug: IV tylenol 1000mg and 2 oral capsule "sugar pills"; Drug: 2 capsules Oral Tylenol 2000 mg and IV "salt water"

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)

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Fort Bragg, North Carolina, United States, 28310
      • Womack Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Acetaminophen is comercially referred to as Tylenol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	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.	24 hours after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Opioid Consumption From Time of First Waking to T24	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	every 6 hours for 24 hours

Collaborators and Investigators

• Sponsor: Defense and Veterans Center for Integrative Pain Management
• Investigators: Principal Investigator: Anthony R Plunkett, MD, Womack Army Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: March 29, 2013
• First Submitted That Met QC Criteria: March 29, 2013
• First Posted (Estimate): April 4, 2013

Study Record Updates

• Last Update Posted (Estimate): June 6, 2016
• Last Update Submitted That Met QC Criteria: May 5, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 380250

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO