Intravenous Acetaminophen Use With Bariatric Surgery on Morbidly Obese Patients

Obesity Clinical Trial

Official title:

Effect of Intravenous Acetaminophen on Postoperative Pain of Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery: A Randomized, Placebo-Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01527942
• Other study ID #: 12-01-003
• Status: Terminated
• Phase: N/A
• First received: February 2, 2012
• Last updated: November 13, 2015
• Start date: March 2012
• Est. completion date: July 2013

Study information

• Verified date: March 2014
• Source: Saint Francis Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Obesity
• Pain

Intervention

Drug:
• Acetaminophen
Intravenous Acetaminophen 1,000 mg IV
• Placebo
Placebo - IV administration 0.9% 100 ml Sodium Chloride (NaCl)

Locations

Country	Name	City	State
United States	Saint Francis Hospital	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Saint Francis Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Relief Score on the 5-point Pain Relief Score Between 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)	baseline and 24 hours	No
Secondary	Change in Pain Intensity on the 10-point Pain Intensity Scale Between 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)	baseline and 24 hours	No
Secondary	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.	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.	24 hours after baseline	No