Intravenous Acetaminophen Use With Bariatric Surgery on Morbidly Obese Patients

Trinity Health Of New England

Status: Terminated

Conditions: Obesity; Pain

Treatments: Drug: Acetaminophen; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01527942

12-01-003

Details and patient eligibility

About

Bariatric patients usually require the use of either intravenous or oral opioid medications. The use of opioids, however, is often associated with side-effects such as nausea, sedation pruritus, urinary retention and respiratory depression with often delay patient discharge. This study makes use of intravenous acetaminophen , a non-opioid analgesic preoperatively to determine if this will decrease the use of opioids post-operatively for pain management in morbidly obese patients undergoing laparoscopic bariatric surgery.

Enrollment: 34 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Morbidly Obese and body mass index (BMI) of 35
• Between ages 20-17
• Candidates for Laparoscopic Bariatric Surgery

Exclusion criteria

• know hypersensitivity to acetaminophen or opioids
• impairment in liver function
• renal dysfunction
• mental retardation

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

34 participants in 2 patient groups, including a placebo group

Arm 1 - Active Drug

Experimental group

Description:

Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.

Treatment:

Drug: Acetaminophen

Arm 2 - Placebo

Placebo Comparator group

Description:

Preoperative IV Placebo (0.9 Sodium Chloride 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.

Treatment:

Drug: Placebo