Effect IV Ibuprofen and Inflammatory Responses

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Rutgers, The State University of New Jersey
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
First received: May 24, 2013
Last updated: April 21, 2014
Last verified: April 2014

This study is being done because the investigators wish to study ways to improve recovery after surgery. Injury, including surgical injury, causes inflammation. Inflammation is the body's attempt to protect itself and to start the healing process. Some surgical complications are related to the body's natural inflammatory response. Although mainly a healing response, inflammation can also have side effects which delay recovery. The investigators wish to determine the effect of a medication known as ibuprofen on recovery. You may know ibuprofen by the name Advil or Motrin. The medication will be given through the vein prior to the start of the surgery. Three blood samples will be taken, two while the patient is under anesthesia. The subject will be asked to complete several questionnaires.

Condition Intervention Phase
Gallbladder Disease
Biological: caldolor
Other: sugar water/placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double Blind, Pilot Study on the Effect of Intravenous Ibuprofen on Inflammatory Responses in Patients Undergoing Surgery With General Anesthesia: Correlation With Clinical Outcomes

Resource links provided by NLM:

Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • inflammatory markers [ Time Frame: 2 hours following end of surgery ] [ Designated as safety issue: No ]
    blood for concentration of cytokines will be drawn Post Anesthesia Care unit at 2 hours following surgery and compared with cytokine levels drawn preoperatively and intraoperatively.

Secondary Outcome Measures:
  • Quality of recovery [ Time Frame: Change from baseline at 48 hours post operatively ] [ Designated as safety issue: No ]
    Quality of recovery score (QoR-40)(forty questions in 5 dimensions), simple fatigue scale (9 questions), digits forward and backward, geriatric depression scale

Estimated Enrollment: 60
Study Start Date: May 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Caldolor
800mg administered IV over 5 minutes
Biological: caldolor
Other Name: intravenous ibuprofen
Placebo Comparator: Sugar water
250mL of normal saline to be administered over 5 minutes
Other: sugar water/placebo
Other Name: 250mL. intravenous sugar water administered over 5 minutes

  Show Detailed Description


Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • undergoing laparoscopic cholecystectomy under general anesthesia
  • American Society of Anesthesiologists status of 1, 2 or 3 (as determined by the anesthesiologists)
  • not pregnant of breast feeding

Exclusion Criteria:

  • cognitively impaired
  • using antipsychotic drugs
  • chronic use of steroids or opioids
  • subject has received COX inhibitors within 3 days if surgery
  • subjects for whom opiates, benzodiazepines and COX inhibitors are contraindicated
  • subjects with a history of bleeding disorders or peptic ulcer disease
  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: NCT01938040

Contact: Alex Bekker, MD, PhD 973 972-5007 bekkeray@umdnj.edu
Contact: Catherine Schoenberg, BSN 973 972-7477 shoenbce@umdnj.edu

United States, New Jersey
University Hospital Not yet recruiting
Newark, New Jersey, United States, 07101
Contact: Alex Bekker, MD, PhD    973-972-5007    bekkeray@umdnj.edu   
Principal Investigator: Alex Bekker, MD, PhD         
United States, New York
New York Methodist Hospital Recruiting
Brooklyn, New York, United States, 11215
Contact: Joel Yarmush, MD, MPA    718-780-5945    jmy@aol.com   
Principal Investigator: Joel Yarmush, MD, MPA         
MT. Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Andrew Perez, MD       andrew.perez@mountsinai.org   
Principal Investigator: Andrew Perez, MD         
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Principal Investigator: Alex Bekker, MD, PhD UMDNJ/NJMS
  More Information

No publications provided

Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT01938040     History of Changes
Other Study ID Numbers: 2012001793
Study First Received: May 24, 2013
Last Updated: April 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Rutgers, The State University of New Jersey:
laparoscopic cholecystectomy

Additional relevant MeSH terms:
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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 September 16, 2014