Role of pregabalin versus duloxetine on pain requirement after lower limb surgery for trauma patients
Phase 4
Completed
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2019/02/017660
- Lead Sponsor
- Government Medical College and Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
American Society of Anesthesiologists (ASA) physical status I and II
Surgery of unilateral tibia or femur following trauma less than one month
Exclusion Criteria
1. Patients having head injury and/or polytrauma including bilateral fractures.
2. Patients having coagulopathy.
3. Patients with Patient Health questionnaire-9 (PHQ-9) and Generalised Anxiety Disorder-7
(GAD-7) > 4.
4. Patients taking medications for chronic pain.
5. Patients with contraindications to pregabalin, duloxetine and diclofenac.
6. Pregnant and lactating women.
7. Patients not able to understand VAS.
8. Patients having history of substance abuse.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to first recue analgesiaTimepoint: Time When patient takes first recue analgesia
- Secondary Outcome Measures
Name Time Method 1. Total cumulative rescue analgesia <br/ ><br>2. VAS at rest and VAS on movement <br/ ><br>3. Patient demographics and socioeconomic status <br/ ><br>4. Haemodynamics. <br/ ><br> 5. Anxiety and depression score <br/ ><br>6. Nausea and vomiting scale <br/ ><br>7. Ramsay sedation score <br/ ><br>8. Patient satisfaction score <br/ ><br>9.VNRS at rest <br/ ><br>VNRS on movement <br/ ><br>Timepoint: 1.At 72 hrs <br/ ><br>2.preoperative, postoperative <br/ ><br>period, at 4, 8, 12, 24, 48 and 72 h <br/ ><br>3.before surgery <br/ ><br>4. preoperatively, in postoperative period, at 4, 8, 12, 24, 48 and 72 h <br/ ><br>5.preoperative visit and at 72 h postoperatively in ward <br/ ><br>6.postoperative period, at <br/ ><br>4, 8, 12, 24, 48 and 72h postoperatively in ward <br/ ><br>7.preoperatively,immediate postoperative period, at 4, 8, <br/ ><br>12, 24, 48 and 72h postoperatively in ward. <br/ ><br>8.72 h postoperatively and postoperative 3 months <br/ ><br>9, postoperative 3 months <br/ ><br>