IV Acetaminophen for Postoperative Analgesia

Phase 4

Terminated

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
IV Acetaminophen	IV Acetaminophen	IV Acetaminophen administered on admission to post-anesthesia care unit
Standard of care	Standard of Care	Standard of care pain management regimen including opioids administered on admission to post-anesthesia care unit

Primary Outcome Measures

Name	Time	Method
Number of Participants With Postoperative Nausea and Vomiting (PONV).	4 hours plus/minus 30 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Post Discharge Nausea and Vomiting (PDNV)	Up to two days following surgery	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.
Highest Pain Intensity Score Using Numeric Rating Scale (NRS)	4 hours plus/minus 30 minutes	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.
Patient Satisfaction on a 5 Point Likert Scale	Up to one week following surgery	Number of patients very satisfied or satisfied with pain and PONV management during hospital stay
Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale	1 hour following surgery	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

Locations (3): Long Island Jewish Medical Center
🇺🇸
New Hyde Park, New York, United States
Syosset Hospital
🇺🇸
Syosset, New York, United States
North Shore University Hospital
🇺🇸
Manhasset, New York, United States