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Study To Check The Analgesic And Anti-Inflammatory Effects Of Atorvastatin In Patients Undergoing Abdominal Surgery (A4S)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by B. J. Medical College, Pune.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
B. J. Medical College, Pune
ClinicalTrials.gov Identifier:
NCT00902967
First received: May 14, 2009
Last updated: June 1, 2009
Last verified: June 2009
History of Changes
  Purpose

The study is planned to check the analgesic and anti-inflammatory properties of Atorvastatin in patients who will be undergoing abdominal surgery under spinal anesthesia. The investigators intend to monitor the analgesic requirements, the rate of wound healing and the inflammatory markers in this trial.


Condition Intervention Phase
Abdominal Surgery
 Drug: Atorvastatin
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double Blind Study Of The Evaluation Of The Potential Analgesic And Anti-Inflammatory Effects Of Atorvastatin In Patients Undergoing Abdominal Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by B. J. Medical College, Pune:

Primary Outcome Measures:
  • Pain as measured on Visual Analogue Scale [ Time Frame: 2, 4, 6, 12, 24 hour post-operative and twice daily till discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain measured on Wong Pain Scale [ Time Frame: 2, 4, 6, 12, 24 hours post-operative and twice daily thereafter till discharge ] [ Designated as safety issue: No ]
  • Pain measured by the McGill Pain Questionnaire [ Time Frame: Once daily till discharge ] [ Designated as safety issue: No ]
  • TNF Alpha Levels [ Time Frame: baseline, on day of surgery, day 4 postoperative ] [ Designated as safety issue: Yes ]
  • Serum Lipid Levels [ Time Frame: Before starting Atorvastatin and at end of study ] [ Designated as safety issue: Yes ]
  • C Reactive Protein Levels [ Time Frame: baseline, on day of surgery, day 4 postoperative ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: July 2009
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Tablet Atorvastatin 10 mg once daily for 5 weeks (1 week before operation till 2 weeks after the operation)
 Drug: Atorvastatin
Atorvastatin 10 mg, once a day dosing at night after meals
Placebo Comparator: 2
Placebo tablets of similar shape and color given at night time dosing
 Drug: Placebo
Placebo tablets of similar shape size and color given once a day at night time after meals

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients aged 25-55 years
  2. Patients who will be undergoing abdominal surgery under spinal anaesthesia
  3. Patients who will undergo non-bowel abdominal surgery with an abdominal incision
  4. Understands and agrees to comply with all study procedures including the daily treatments and follow-up visits
  5. Able to understand and is voluntarily willing to sign an informed consent form for this study
  6. Weight between 50 and 120 kg

Exclusion Criteria:

  1. Bowel surgery or surgery under general anaesthesia
  2. Any emergency operations
  3. Surgery in patients in whom the chances of infection are very high. Example peritonitis, cystitis, appendical abscess, perforations, etc
  4. Laparoscopic Surgery
  5. Pregnant or nursing, or with the ability to become pregnant and not using an accepted form of birth control
  6. Any active Cancer
  7. Uncontrolled diabetes mellitis
  8. Untreated hypertension
  9. Psychotic disorder(s), dementia, mental retardation, or other organic mental disorders (subjects who are not mentally and physically able to personally consent for participation in this study are not eligible)
  10. Any other (including acute) condition, which in the opinion of the investigator, is likely to cause non-compliance or significantly impact treatment outcomes
  11. Sensitivity to the study drug or its components
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902967

Contacts
Contact: Bharati Daswani, M.D. Phd 919421965337 daswani_bharti@rediffmail.com
Contact: Aaditya S Udupa, M.B.B.S 919823333793 draaditya.udupa@gmail.com

Locations
India
Department of Pharmacology, Sassoon General Hospitals Not yet recruiting
Pune, Maharastra, India, 411001
Contact: Bharati Daswani, M.D, PhD     919421965337     daswani_bharti@rediffmail.com    
Contact: Aaditya S Udupa, M.B.B.S     919823333793     draaditya.udupa@gmail.com    
Principal Investigator: Aaditya S Udupa, M.B.B.S            
Sponsors and Collaborators
B. J. Medical College, Pune
  More Information

No publications provided

Responsible Party: Dr Bharati Daswani, Assosiate Proffessor, Department of Pharmacology, B. J. medical College & Sassoon General Hospitals
ClinicalTrials.gov Identifier: NCT00902967     History of Changes
Other Study ID Numbers: ASU 1
Study First Received: May 14, 2009
Last Updated: June 1, 2009
Health Authority: India: Ministry of Health

Keywords provided by B. J. Medical College, Pune:
Postoperative pain
atorvastatin
analgesic
antiinflammatory

Additional relevant MeSH terms:
Analgesics
Anti-Inflammatory Agents
Atorvastatin
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on May 23, 2013