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We add either Dexamethasone or Ketamine,with Bupivacaine during spinal anaesthesia and we observe the duration of pain free period after surgery with both added drug and will decide which one give more pain free period after surgery.

Comparison of duration of analgesia after adding intrathecal dexamethasone or ketamine as an adjuvant to bupivacaine in spinal anaesthesia for lower limb orthopaedic surgery.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/05/042633
Enrollment
64
Registered
2022-05-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: S820- Fracture of patella Health Condition 2: S821- Fracture of upper end of tibia Health Condition 3: S822- Fracture of shaft of tibia Health Condition 4: S823- Fracture of lower end of tibia Health Condition 5: S824- Fracture of shaft of fibula Health Condition 6: S825- Fracture of medial malleolus Health Condition 7: S826- Fracture of lateral malleolus Health Condition 8: S829- Unspecified fracture of lower leg

Interventions

Intervention1: Spinal anaesthesia: Spinal anaesthesia will be given with either 0.5%bupivacaine heavy+ 4mg Dexamethasone or 0.5% bupivacaine heavy+Ketamine25mg Control Intervention1: Bupivacaine,Ketam

Sponsors

Principal investigator Dr Sonik Shah
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria : 1 Age 18-60 years 2 Lower limb Orthopedic surgery 3 ASA physical status 1 or 2 4 Scheduled for planned Surgery on tibia 5 Patients who could understand and rate their pain on VAS scale (0-10) able to provide written consent

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1 Patientâ??s refusal 2 Emergency surgery 3 Pediatric patient 4 History of Anaphylaxis or Allergy to Local anesthetics 5 History of Bleeding Disorders 6 History of Drug abuse 7 Spine deformity 8 Neurological and cardiac disease 9 Infection at site of Spinal Anesthesia 10 Inability to provide informed consent

Design outcomes

Primary

MeasureTime frame
Patient will be asked for pain and motor recovery every hourly in post operative period in recovery room or in ward, Neurological recovery will also be assessed using Modified Bromage Scale 1 hourly, On patientâ??s request/VAS 4 and Modified Bromage Scale Grade 5, Rescue analgesia of 50 mg Tramadol in 100 ml NS over 20 min to be given.Timepoint: Patient will be asked for pain and motor recovery every hourly in post operative period in recovery room or in ward, Neurological recovery will also be assessed using Modified Bromage Scale 1 hourly, On patientâ??s request/VAS 4 and Modified Bromage Scale Grade 5, Rescue analgesia of 50 mg Tramadol in 100 ml NS over 20 min to be given.—

Secondary

MeasureTime frame
nausea Vomiting Hypotension SedationTimepoint: One hourly—

Countries

India

Contacts

Public ContactDr Sonik G Shah

Dr. N. D. Desai Faculty of Medical Science and Research

drsonik@gmail.com9979788588

Outcome results

None listed

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