Intravenous Acetaminophen Use With Bariatric Surgery on Morbidly Obese Patients

• ClinicalTrials.gov Identifier: NCT01527942
• Recruitment Status: Terminated
• First Posted: February 7, 2012
• Results First Posted: December 17, 2015
• Last Update Posted: December 17, 2015
• Sponsor: Saint Francis Care
• Information provided by (Responsible Party): Saint Francis Care

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Obesity; Pain	Drug: Acetaminophen; Drug: Placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Diagnostic
• Official Title: Effect of Intravenous Acetaminophen on Postoperative Pain of Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery: A Randomized, Placebo-Controlled Trial
• Study Start Date: March 2012
• Actual Primary Completion Date: July 2013
• Actual Study Completion Date: July 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm 1 - Active Drug; 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.	Drug: Acetaminophen; Intravenous Acetaminophen 1,000 mg IV; Other Name: OFIRMEV
Placebo Comparator: Arm 2 - Placebo; 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.	Drug: Placebo; Placebo - IV administration 0.9% 100 ml Sodium Chloride (NaCl)

Outcome Measures

Primary Outcome Measures :

1. Change in Pain Relief Score on the 5-point Pain Relief Score Between Baseline and 24 Hours [ Time Frame: baseline and 24 hours ]
   The 5-point Pain Relief Score is self-reported and scores range from 0=none, 1=little, 2=some, 3=a lot, 4=complete. Change = (24 hour score - baseline)

Secondary Outcome Measures :

1. Change in Pain Intensity on the 10-point Pain Intensity Scale Between Baseline and 24 Hours [ Time Frame: baseline and 24 hours ]
   The 10-point Pain Intensity Scale is self-reported and scores range from 0=no pain to10=worst possible. Change = (24 hour score - baseline)
2. Response Rate - of 3=Excellent at Hour 24 Using 4-point Global Satisfaction With Regards to Overall Pain Management Rating Scale 0=Poor to 3= Excellent. [ Time Frame: 24 hours after baseline ]
   The 4-point patient global satisfaction of pain management scale is self-reported and scores range from 0=poor to 3=excellent. Response rate of 3=excellent at 24 hours after baseline.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Connecticut

Saint Francis Hospital

Hartford, Connecticut, United States, 06105

Sponsors and Collaborators

Saint Francis Care

Investigators

• Principal Investigator: Ioannis Raftopoulos, MD; Saint Francis

More Information

• Responsible Party: Saint Francis Care
• ClinicalTrials.gov Identifier: NCT01527942
• Other Study ID Numbers: 12-01-003
• First Posted: February 7, 2012
• Results First Posted: December 17, 2015
• Last Update Posted: December 17, 2015
• Last Verified: March 2014

Keywords provided by Saint Francis Care:

Pain Management

Additional relevant MeSH terms:

Acetaminophen; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Antipyretics