IV Acetaminophen for Postoperative Analgesia

NCT ID: NCT01798316

Last Updated: 2017-05-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-09-30

Brief Summary

The purpose of this study is to evaluate the use of IV acetaminophen for postoperative pain management after laparoscopic cholecystectomy to determine if its use to supplement standard of care pain management decreases the incidence of post-operative nausea and vomiting.

Detailed Description

The recent clinical development of an intravenous (IV) acetaminophen formulation for use in the US has important implications for the management of postoperative pain given its safety profile and suitability for use in the early phase of the postoperative period. In clinical studies a significant opioid-sparing effect has been documented with a substantial percentage of patients avoiding the need for opioid rescue medication altogether. This avoidance or delay in the use of opioids has been shown to reduce undesirable side effects. It is proposed that the use of IV acetaminophen in the post anesthesia care unit (PACU) for postoperative analgesia after laparoscopic cholecystectomy will result in decreased incidence of post operative nausea and vomiting (PONV) and decreased use of narcotics.

Conditions

Postoperative Pain; Postoperative Nausea; Postoperative Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

IV Acetaminophen

IV Acetaminophen administered on admission to post-anesthesia care unit

Group Type: ACTIVE_COMPARATOR

IV Acetaminophen

Intervention Type: DRUG

Single dose, 1000g mg infusion over 15 minutes plus standard of care pain management regimen

Standard of care

Standard of care pain management regimen including opioids administered on admission to post-anesthesia care unit

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: DRUG

Standard of care pain management regimen, no IV Acetaminophen,

Interventions

IV Acetaminophen

Single dose, 1000g mg infusion over 15 minutes plus standard of care pain management regimen

Intervention Type: DRUG

Standard of Care

Standard of care pain management regimen, no IV Acetaminophen,

Intervention Type: DRUG

Other Intervention Names

Ofirmev; As per provider: Opioids

Eligibility Criteria

Inclusion Criteria

• Subject is undergoing pre-scheduled laparoscopic cholecystectomy;
• American Society of Anesthesiology patient classification status I-II

Exclusion Criteria

• Regular preoperative use of or opioids,
• Subjects admitted after surgery for postoperative complications other than postoperative pain or PONV.
• Subjects converted to open laparoscopic cholecystectomy
• Known allergy/hypersensitivity to acetaminophen
• Use of opioids prior to commencement of the study (<7 days)
• Patients with chronic pain conditions or disease requiring pain control
• Abnormal liver function
• Known or suspected alcohol, drug or opiate abuse or dependence
• Patients with a BMI of greater than 35
• Other physical, mental or medical conditions that could effect participation.
• Abnormal renal function; serum creatinine>2gm/dl

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frank J Overdyk, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

North Shore University Hospital

Manhasset, New York, United States

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Syosset Hospital

Syosset, New York, United States

Countries

United States

Other Identifiers

IRB #12-409B

Identifier Type: OTHER

Identifier Source: secondary_id

12-0409

Identifier Type: -

Identifier Source: org_study_id