IV Acetaminophen for Postoperative Analgesia

Phase 4TerminatedNCT01798316

Northwell Health105 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

105

Conditions

Postoperative Pain Postoperative Nausea Postoperative Vomiting

Interventions

IV AcetaminophenDRUG

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

Standard of CareDRUG

Standard of care pain management regimen, no IV Acetaminophen,

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (3)

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

Outcomes

Primary Outcomes

Number of Participants With Postoperative Nausea and Vomiting (PONV).

Number of participants with postoperative nausea and vomiting (PONV) will be recorded during PACU stay. PONV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching.

Time frame: 4 hours plus/minus 30 minutes

Secondary Outcomes

Number of Participants With Post Discharge Nausea and Vomiting (PDNV)

Number of participants reporting post discharge nausea and vomiting (PDNV) documented up to 2 days following surgery. PDNV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching following discharge.

Time frame: Up to two days following surgery

Highest Pain Intensity Score Using Numeric Rating Scale (NRS)

Highest pain intensity reported during PACU stay using a 11-point (0-10) pain intensity numeric rating scale (NRS). Higher values represent higher pain intensities.

Time frame: 4 hours plus/minus 30 minutes

Patient Satisfaction on a 5 Point Likert Scale

Number of patients very satisfied or satisfied with pain and PONV management during hospital stay

Time frame: Up to one week following surgery

Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale

Pain intensity score reported by participants 1 hour following surgery using an 11-point, 0-10 Numeric Rating Scale (NRS). Higher scores indicate higher pain intensities

Time frame: 1 hour following surgery

Data from ClinicalTrials.gov

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