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A clinical trial to study the effect of a drug pregabalin in two different doses on preoperative anxiety and postoperative pain in patients undergoing total abdominal hysterectomy

EFFECT OF PREGABALIN ON PREOPERATIVE ANXIETY AND POSTOPERATIVE PAIN AFTER TOTAL ABDOMINAL HYSTERECTOMY - A DOSE RANGING STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/000402
Enrollment
60
Registered
2010-04-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Prevention of Post operative pain in patients undergoing total abdominal hysterectomy

Interventions

Intervention1: Pregabalin: Pregabalin capsule (150 mg) and pregabalin capsule (300mg), two hours before the anesthetic induction Control Intervention1: Placebo: Two placebo capsule, two hours before

Sponsors

Depatment of Anaesthesiology All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for TAH 2. Age-18 to 65 years 3. Ability to operate a patient controlled analgesia (PCA) pump after pre surgery instructions

Exclusion criteria

Exclusion criteria: 1. Obesity > 130 % of ideal body weight, 2. History of chronic pain, 3. Regular medications with analgesic, 4. Analgesic use within 24 hours of surgery, 5. Drug or Alcohol abuse, 6. Psychiatric disorders, 7. Cardiovascular, renal or hepatic disease, 8. Known hypersensitivity to the pregabalin

Design outcomes

Primary

MeasureTime frame
1. Anxiolysis 2. Post operative analgesia 3. Opioid sparing effect Timepoint: First 24 hrs in the postoperative period—

Secondary

MeasureTime frame
1.Reduction in Opioid related adverse effects such as: Respiratory Depression;Nausea and Vomiting;Pruritis;Sedation 2.Patient Satisfaction Timepoint: First 24 hrs in the postoperative period—

Countries

India

Contacts

Public ContactRahul Kumar Anand

Dept. of Anaesthesiology,All India Institute of Medical Sciences,Ansari Nagar ,New Delhi -110029

rahulanand00@gmail.com09013082271

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026