IV Acetaminophen for Postoperative Analgesia

Northwell Health

Status and phase: Terminated; Phase 4

Conditions: Postoperative Pain; Postoperative Vomiting; Postoperative Nausea

Treatments: Drug: IV Acetaminophen; Drug: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT01798316

IRB #12-409B (Other Identifier)

12-0409

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

105 participants in 2 patient groups

IV Acetaminophen

Active Comparator group

Description:

IV Acetaminophen administered on admission to post-anesthesia care unit

Treatment:

Drug: IV Acetaminophen

Standard of care

Active Comparator group

Description:

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

Treatment:

Drug: Standard of Care