Intravenous Ibuprofen for Laparoscopic Bariatric Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Jacobi Medical Center
Sponsor:
Collaborators:
Cumberland Pharmaceuticals
Sagatech Electronics Inc, Alberta, Canada
Information provided by (Responsible Party):
Mindaugas Pranevicius, Jacobi Medical Center
ClinicalTrials.gov Identifier:
NCT01707251
First received: October 10, 2012
Last updated: October 24, 2012
Last verified: October 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014