Role of pregabalin versus duloxetine on pain requirement after lower limb surgery for trauma patients

Effect of pregabalin versus duloxetine on analgesic requirement following lower limb trauma surgeries: a randomized, clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/02/017660

Enrollment

Registered

2019-02-14

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: O- Medical and Surgical

Interventions

Intervention1: Group I: 30 patients will be given 150 mg pregabalin 2 h prior to surgery and once a day for two days after the surgery. Control Intervention1: Group II: 30 patients will be given 60 mg

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Time to first recue analgesiaTimepoint: Time When patient takes first recue analgesia	—

Secondary

Measure	Time frame
1. Total cumulative rescue analgesia 2. VAS at rest and VAS on movement 3. Patient demographics and socioeconomic status 4. Haemodynamics. 5. Anxiety and depression score 6. Nausea and vomiting scale 7. Ramsay sedation score 8. Patient satisfaction score 9.VNRS at rest VNRS on movement Timepoint: 1.At 72 hrs 2.preoperative, postoperative period, at 4, 8, 12, 24, 48 and 72 h 3.before surgery 4. preoperatively, in postoperative period, at 4, 8, 12, 24, 48 and 72 h 5.preoperative visit and at 72 h postoperatively in ward 6.postoperative period, at 4, 8, 12, 24, 48 and 72h postoperatively in ward 7.preoperatively,immediate postoperative period, at 4, 8, 12, 24, 48 and 72h postoperatively in ward. 8.72 h postoperatively and postoperative 3 months 9, postoperative 3 months	—

Measure

Time frame

1. Total cumulative rescue analgesia 2. VAS at rest and VAS on movement 3. Patient demographics and socioeconomic status 4. Haemodynamics. 5. Anxiety and depression score 6. Nausea and vomiting scale 7. Ramsay sedation score 8. Patient satisfaction score 9.VNRS at rest VNRS on movement Timepoint: 1.At 72 hrs 2.preoperative, postoperative period, at 4, 8, 12, 24, 48 and 72 h 3.before surgery 4. preoperatively, in postoperative period, at 4, 8, 12, 24, 48 and 72 h 5.preoperative visit and at 72 h postoperatively in ward 6.postoperative period, at 4, 8, 12, 24, 48 and 72h postoperatively in ward 7.preoperatively,immediate postoperative period, at 4, 8, 12, 24, 48 and 72h postoperatively in ward. 8.72 h postoperatively and postoperative 3 months 9, postoperative 3 months

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Countries

India

Contacts

Public ContactVanita Ahuja

Government Medical College and Hospital

alishachachra20@yahoo.co.in9855203232

Outcome results

None listed

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