Intravenous Ibuprofen for Laparoscopic Bariatric Surgery - Full Text View

Purpose

Primary objective of this study is to test hypothesis that IV ibuprofen decreases 24 hours morphine requirement using IV PCA in patients after laparoscopic bariatric surgery. Secondary objective is to determine if it decreases respiratory depression measured using RD, improves area under curve (AUC) for pain scores at rest (AUCr) and with cough (AUCa) and pressure pain threshold (PPT) (important for mobilization). Tertiary objective is to compare incidence of nausea/vomiting, sedation, itching, blood transfusion, over sedation, urinary retention, GI or surgical bleeding, renal dysfunction, time to clears and baseline activity in ibuprofen and control groups.

Condition	Intervention	Phase
Obesity	Drug: Intravenous Ibuprofen Drug: Saline	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Intravenous Ibuprofen for Laparoscopic Bariatric Surgery

Resource links provided by NLM:

MedlinePlus related topics: Depression Obesity Weight Loss Surgery

Drug Information available for: Ibuprofen Ibuprofen sodium Ibuprofen lysinate

U.S. FDA Resources

Further study details as provided by Jacobi Medical Center:

Primary Outcome Measures:

24 hours postoperative morphine requirement using IV PCA [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Will test if IV ibuprofen decrease postoperative morphine requirement.

Secondary Outcome Measures:

Respiratory depression [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: Yes ]
Compare respiratory disturbance index preoperatively versus postoperatively and incidence of hypoxia (SpO2 <95, <90 and <80%) in ibuprofen and placebo groups.
Pain scores [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
Area under curve for pain scores at rest (AUCr) and with cough (AUCa).
Pressure pain thresholds [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Preoperative versus postoperative pressure pain threshold (PPT) will be measured to assess effect of ibuprofen on PPT (important for mobilization).

Other Outcome Measures:

Nausea/vomiting [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Compare incidence of nausea vomiting between groups.
Transfusion requirement [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
Compare incidence of blood transfusions between groups.
Urinary retention [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Incidence of recatheterization after foley removal between groups.
Surgical bleeding [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Incidence of reoperation for bleeding in ibuprofen and control groups.
Incidence of renal dysfunction [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
Compare preoperative versus discharge GFR in ibuprofen and control groups.
Time to oral intake [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Time to clears in ibuprofen and control groups.
Return of baseline activity [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Time to baseline activity in ibuprofen and control groups
Time patient meets discharge criteria from the PACU (hours) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Time to discharge from PACU (hours) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Time to discharge from hospital (hours) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Time to ambulation (hours) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Incidence of readmission within 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Incidence of reoperation within 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Incidence of DVT [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Max temperature [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Time to oral tolerance (clears, solids) (hours) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Antiemetic requirement (number of doses) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Time to bowel movement (hours) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Incidence of over sedation (sedation score 3 and 4) [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Naloxone requirement [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Patient satisfaction scores [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Time to out of bed to chair (hours) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Time to stand-up (hours) [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	October 2012
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Intravenous Ibuprofen 800 mg Ibuprofen IV every 6 hours starting preoperatively (5 doses).	Drug: Intravenous Ibuprofen 800 mg Ibuprofen IV every 6 hours starting preoperatively (5 doses). Other Name: Caldorol
Placebo Comparator: Saline IV saline every 6 hours starting preoperatively (5 doses).	Drug: Saline Placebo control

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients scheduled for laparoscopic bariatric surgery at Jacobi Medical Center

Exclusion Criteria:

Patients with history of ibuprofen or aspirin allergy
morphine allergy
opioid or psychotropic medication use pre-operatively
positive preoperative U-tox screening
unable to sign consent and patients unable to understand or use patient controlled analgesia (PCA) or report pain intensity
GFR <60 or history of GI bleed within 6 weeks

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01707251

Contacts

Contact: Howard Nadel	718-918-7070	Howard.Nadel@nbhn.net
Contact: Denise Sullivan	718-918-6867	Denise.Sullivan@nbhn.net

Locations

United States, New York
Jacobi Medical Center	Recruiting
Bronx, New York, United States, 10461
Principal Investigator: Mindaugas Pranevicius, MD
Sub-Investigator: Leonard Golden, MD
Sub-Investigator: Ajay Chopra, MD
Sub-Investigator: Denise Sullivan, NP
Sub-Investigator: Teimuraz Gaprindashvili, MD
Sub-Investigator: Jayne Lieb, MD
Sub-Investigator: Claudia Calderone, RN
Sub-Investigator: Lynn Merklinger, NP

Sponsors and Collaborators

Jacobi Medical Center

Cumberland Pharmaceuticals

Sagatech Electronics Inc, Alberta, Canada

Investigators

Principal Investigator:

Mindaugas Pranevicius, MD

Jacobi Medical Center

More Information

No publications provided

Responsible Party:	Mindaugas Pranevicius, Attending Anesthesiologist, Director of Pain Medicine, Jacobi Medical Center
ClinicalTrials.gov Identifier:	NCT01707251 History of Changes
Other Study ID Numbers:	2011_436
Study First Received:	October 10, 2012
Last Updated:	October 24, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Jacobi Medical Center:

Obesity, Morbid
Bariatric Surgery
Laparoscopy

Intravenous Ibuprofen
Analgesia
Morphine

Additional relevant MeSH terms:

Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013