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Completed

NCT Number: NCT01823224

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

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.

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Key information

Conditions

Laparoscopic Cholecystectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Womack Army Medical Center

Fort Bragg, North Carolina, 28310, United States

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

2 capsules Oral Tylenol 2000 mg and IV "salt water"

Drug

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.

IV tylenol 1000mg and 2 oral capsule "sugar pills"

Drug

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.

Primary outcomes

  1. Pain

    Time frame: 24 hours after discharge

    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 outcomes

  1. Total Opioid Consumption From Time of First Waking to T24

    Time frame: every 6 hours for 24 hours

    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

Sponsors and collaborators

Lead sponsor

Defense and Veterans Center for Integrative Pain Management

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 4, 2013
Registry last updated
Jun 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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