Study to see if a pain relief medicine can also improve sleep after surgery for leg fractures.

Effect of Gabapentin on sleep quality and post operative pain relief in patients undergoing lower limb trauma surgery - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/092240

Enrollment

120

Registered

2025-08-04

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

Health Condition 1: M249- Joint derangement, unspecified

Interventions

Intervention1: Gabapentin: Patients will be given 300mg Gabapentin 2 hours before surgery and 300mg at 12 hours after surgery Control Intervention1: Placebo: Patients will be given placebo drug 2 hour

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 18-65 years 2.American Society of Anaesthesiologists (ASA) physical status I and II 3.Lower limb surgery following trauma less than three months 4.Duration of surgery less than equal to 4 hours

Exclusion criteria

Exclusion criteria: 1. Patients having head injury and/or polytrauma 2. Contraindications to spinal anaesthesia 3. Contraindications to Gabapentin 4. Pregnant and lactating women 5. Patients not able to understand VAS or PSQI scale 6. Patients having history of substance abuse 7. Patients with preexisting sleep disorders 8. Patients already on Gabapentin

Design outcomes

Primary

Measure	Time frame
Sleep quality using PSQI sleep score Timepoint: 48 hours after surgery in ward	—

Secondary

Measure	Time frame
1. Sleep quality using PSQI sleep score 2.Postoperative pain relief using VAS score 3. Haemodynamics 4. Ramsay sedation score 5. Total cumulative rescue analgesia (Diclofenac) consumed 6. Total cumulative rescue analgesia(tramadol) consumedTimepoint: 1.Preoperative ,24 hours after surgery 2.Preop, PACU, 4,8,12,24 and 48 hours 3. Preop, PACU, 4,8,12,24 and 48 h 4. Preop,PACU, 4,8,12,24 and 48 h 5. Preop, PACU, 4,8,12,24 and 48 h 6. Preop PACU, 4,8,12,24 and 48 h	—

Measure

Time frame

1. Sleep quality using PSQI sleep score 2.Postoperative pain relief using VAS score 3. Haemodynamics 4. Ramsay sedation score 5. Total cumulative rescue analgesia (Diclofenac) consumed 6. Total cumulative rescue analgesia(tramadol) consumedTimepoint: 1.Preoperative ,24 hours after surgery 2.Preop, PACU, 4,8,12,24 and 48 hours 3. Preop, PACU, 4,8,12,24 and 48 h 4. Preop,PACU, 4,8,12,24 and 48 h 5. Preop, PACU, 4,8,12,24 and 48 h 6. Preop PACU, 4,8,12,24 and 48 h

—

Countries

India

Contacts

Public ContactRiya Ahuja

Government Medical College and Hospital Chandigarh , Sector 32-B

vanitaahujameetings2020@gmail.con9646121649

Outcome results

None listed

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