Outcome of IV Acetaminophen Use in Laparoscopic Cholecystectomies in Patients at Risk of OSA

• ClinicalTrials.gov Identifier: NCT02056678
• Recruitment Status: Withdrawn
• First Posted: February 6, 2014
• Last Update Posted: November 3, 2016
• Sponsor: The University of Texas Health Science Center at San Antonio
• Information provided by (Responsible Party): The University of Texas Health Science Center at San Antonio

Study Description

Brief Summary:

The objective of this study is to determine if IV acetaminophen administered intraoperatively can decrease the dose of narcotics required for adequate pain control and shorten recovery time in the PACU specifically in obese patients at risk for obstructive sleep apnea.

Condition or disease	Intervention/treatment	Phase
Cholecystitis; Cholelithiasis; Obstructive Sleep Apnea	Drug: acetaminophen, IV preparation	Phase 4

Detailed Description:

Obese adult patients at risk for having OSA will be randomized into two groups: those receiving intraoperative IV acetaminophen and those not receiving the drug. The patients will be blinded to the administration of acetaminophen. For the group randomized to receive the study drug, anesthesia providers will be instructed to administer 1000mg of IV acetaminophen intraoperatively immediately after induction. They may utilize narcotics and other pain medication perioperatively at their discretion according to their perceived patients' needs. Post-operatively in the recovery unit, all patients will be monitored according to current standards with appropriate oxygen supplementation as needed, and they may receive narcotics or other adjuncts as ordered by the anesthesia provider. Recovery nurses will record vital signs, Aldrete score, pain score, and drugs administered per standard protocol. The recovery nurses will be blinded to the study group, and no patients regardless of control vs. study group will be allowed to receive acetaminophen in the PACU or for six hours from surgery end time due to FDA approved dosing of IV acetaminophen no more frequently than every six hours. The patients' recovery data will then be de-identified and reviewed, and each of the groups' recovery time, narcotic use, pain score, and any complications will be examined and compared.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Use of IV Acetaminophen Intraoperatively in Obese Patients at Risk for Obstructive Sleep Apnea Undergoing Laparoscopic Cholecystectomy
• Study Start Date: February 2014
• Actual Primary Completion Date: June 2014
• Actual Study Completion Date: June 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: IV acetaminophen, OSA, laparoscopic cholecystectomy; IV acetaminophen 1000mg to be administered to obese patients at risk of obstructive sleep apnea intraoperatively during laparoscopic cholecystectomy	Drug: acetaminophen, IV preparation; Other Name: Ofirmev
No Intervention: OSA, laparoscopic cholecystectomy, narcotics; No IV acetaminophen in obese patients at risk of obstructive sleep apnea intraoperatively during laparoscopic cholecystectomy; patients will receive other modalities for pain control primarily including IV narcotics

Outcome Measures

Primary Outcome Measures :

1. reduction in pain scores in PACU [ Time Frame: PACU stay (1-2 hours) ]
   The study will evaluate if patients who receive IV acetaminophen intraoperatively have a reduction in pain scores in the PACU

Secondary Outcome Measures :

1. reduced narcotic use in PACU [ Time Frame: PACU stay (1-2 hours) ]
   The study will evaluate if patients who receive IV acetaminophen intraoperatively have a reduction in narcotic use in the PACU and therefore have less adverse events related to increased narcotic use such as respiratory depression or failure requiring prolonged supplemental oxygen or respiratory support, increased nausea and vomiting, longer PACU stay, and allergic reactions.
2. amount of time for recovery in PACU based on Aldrete score [ Time Frame: PACU stay (1-2 hours) ]
   The study will evaluate if patients who receive IV acetaminophen intraoperatively have a reduction in recovery time, i.e., reduction in time to the patient's baseline Aldrete score.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Obesity (BMI greater than or equal to 30)
• Symptoms of obstructive sleep apnea as determined by an OSA questionnaire patients will complete preoperatively
• Prior diagnosis of obstructive sleep apnea
• Undergoing laparoscopic cholecystectomy
• 18 years old or greater

Exclusion Criteria:

• Negative OSA questionnaire or recent negative workup
• Open cholecystectomy or conversion to open procedure intraoperatively
• Allergy to acetaminophen
• Severe hepatic dysfunction
• Pediatric patients
• Patients unable to consent for themselves

Contacts and Locations

Locations

United States, Texas

University Health System

San Antonio, Texas, United States, 78229

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

Investigators

• Principal Investigator: Erik Boatman, MD; University of Texas Health Science Center- San Antonio

More Information

Publications of Results:

Abdulla S, Eckhardt R, Netter U, Abdulla W. A randomized, double-blind, controlled trial on non-opioid analgesics and opioid consumption for postoperative pain relief after laparoscopic cholecystectomy. Acta Anaesthesiol Belg. 2012;63(1):43-50.

Other Publications:

Ankichetty S, Wong J, Chung F. A systematic review of the effects of sedatives and anesthetics in patients with obstructive sleep apnea. J Anaesthesiol Clin Pharmacol. 2011 Oct;27(4):447-58. doi: 10.4103/0970-9185.86574.

Chung SA, Yuan H, Chung F. A systemic review of obstructive sleep apnea and its implications for anesthesiologists. Anesth Analg. 2008 Nov;107(5):1543-63. doi: 10.1213/ane.0b013e318187c83a. Review.

Chung F, Subramanyam R, Liao P, Sasaki E, Shapiro C, Sun Y. High STOP-Bang score indicates a high probability of obstructive sleep apnoea. Br J Anaesth. 2012 May;108(5):768-75. doi: 10.1093/bja/aes022. Epub 2012 Mar 8.

Lavie L. Obstructive sleep apnoea and acetaminophen safety - is the liver at risk? Exp Physiol. 2009 Feb;94(2):199-200. doi: 10.1113/expphysiol.2008.045906.

O'Neal JB. The utility of intravenous acetaminophen in the perioperative period. Front Public Health. 2013 Aug 6;1:25. doi: 10.3389/fpubh.2013.00025. Review.

• Responsible Party: The University of Texas Health Science Center at San Antonio
• ClinicalTrials.gov Identifier: NCT02056678 History of Changes
• Other Study ID Numbers: HSC20140011H
• First Posted: February 6, 2014
• Last Update Posted: November 3, 2016
• Last Verified: November 2016

Keywords provided by The University of Texas Health Science Center at San Antonio:

cholecystitis; cholelithiasis; obstructive sleep apnea; acetaminophen

Additional relevant MeSH terms:

Cholecystitis; Acalculous Cholecystitis; Cholelithiasis; Cholecystolithiasis; Gallstones; Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Calculi; Pathological Conditions, Anatomical; Acetaminophen; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Antipyretics