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
Information provided by:
B. J. Medical College, Pune Identifier:
First received: May 14, 2009
Last updated: June 1, 2009
Last verified: June 2009
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:

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


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

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
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 identifier: NCT00902967

Contact: Bharati Daswani, M.D. Phd 919421965337
Contact: Aaditya S Udupa, M.B.B.S 919823333793

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

Responsible Party: Dr Bharati Daswani, Assosiate Proffessor, Department of Pharmacology, B. J. medical College & Sassoon General Hospitals 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

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Atorvastatin Calcium
Anticholesteremic Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 26, 2016