NCT00902967

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 15, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

June 3, 2009

Status Verified

June 1, 2009

Enrollment Period

5 months

First QC Date

May 14, 2009

Last Update Submit

June 1, 2009

Conditions

Abdominal Surgery

Keywords

Postoperative painatorvastatinanalgesicantiinflammatory

Outcome Measures

Primary Outcomes (1)

  • Pain as measured on Visual Analogue Scale

    2, 4, 6, 12, 24 hour post-operative and twice daily till discharge

Secondary Outcomes (5)

  • Pain measured on Wong Pain Scale

    2, 4, 6, 12, 24 hours post-operative and twice daily thereafter till discharge

  • Pain measured by the McGill Pain Questionnaire

    Once daily till discharge

  • TNF Alpha Levels

    baseline, on day of surgery, day 4 postoperative

  • Serum Lipid Levels

    Before starting Atorvastatin and at end of study

  • C Reactive Protein Levels

    baseline, on day of surgery, day 4 postoperative

Study Arms (2)

1

ACTIVE COMPARATOR

Tablet Atorvastatin 10 mg once daily for 5 weeks (1 week before operation till 2 weeks after the operation)

Drug: Atorvastatin

2

PLACEBO COMPARATOR

Placebo tablets of similar shape and color given at night time dosing

Drug: Placebo

Interventions

AtorvastatinDRUG

Atorvastatin 10 mg, once a day dosing at night after meals

1
PlaceboDRUG

Placebo tablets of similar shape size and color given once a day at night time after meals

2

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Bowel surgery or surgery under general anaesthesia
  • Any emergency operations
  • Surgery in patients in whom the chances of infection are very high. Example peritonitis, cystitis, appendical abscess, perforations, etc
  • Laparoscopic Surgery
  • Pregnant or nursing, or with the ability to become pregnant and not using an accepted form of birth control
  • Any active Cancer
  • Uncontrolled diabetes mellitis
  • Untreated hypertension
  • 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)
  • Any other (including acute) condition, which in the opinion of the investigator, is likely to cause non-compliance or significantly impact treatment outcomes
  • Sensitivity to the study drug or its components

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pharmacology, Sassoon General Hospitals

Pune, Maharashtra, 411001, India

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Central Study Contacts

Bharati Daswani, M.D. Phd

CONTACT

919421965337daswani_bharti@rediffmail.com

Aaditya S Udupa, M.B.B.S

CONTACT

919823333793draaditya.udupa@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 14, 2009

First Posted

May 15, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2009

Study Completion

February 1, 2010

Last Updated

June 3, 2009

Record last verified: 2009-06

Locations

IN(1)