IV Acetaminophen for Postoperative Analgesia

Postoperative Pain Clinical Trial

Official title:

IV Acetaminophen for Postoperative Analgesia After Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01798316
• Other study ID #: 12-0409
• Secondary ID: IRB #12-409B
• Status: Terminated
• Phase: Phase 4
• First received: February 5, 2013
• Last updated: May 30, 2017
• Start date: March 2013
• Est. completion date: September 2015

Study information

• Verified date: May 2017
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 105
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Pain, Postoperative
• Postoperative Nausea
• Postoperative Nausea and Vomiting
• Postoperative Pain
• Postoperative Vomiting
• Vomiting

Intervention

Drug:
• IV Acetaminophen
Single dose, 1000g mg infusion over 15 minutes plus standard of care pain management regimen
• Standard of Care
Standard of care pain management regimen, no IV Acetaminophen,

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Patients Requiring Rescue Analgesia for Breakthrough Pain	Number of patients requiring rescue analgesia medication during first hour of PACU stay	1 hour following surgery
Other	Narcotic Use During PACU Stay	Narcotic medication administered during PACU stay in morphine milligram equivalents	4 hours plus/minus 30 minutes
Primary	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.	4 hours plus/minus 30 minutes
Secondary	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.	Up to two days following surgery
Secondary	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.	4 hours plus/minus 30 minutes
Secondary	Patient Satisfaction on a 5 Point Likert Scale	Number of patients very satisfied or satisfied with pain and PONV management during hospital stay	Up to one week following surgery
Secondary	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	1 hour following surgery