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.
- Conditions
- Fracture of patella, (2) ICD-10 Condition: S821||Fracture of upper end of tibia, (3) ICD-10 Condition: S822||Fracture of shaft of tibia, (4) ICD-10 Condition: S823||Fracture of lower end of tibia, (5) ICD-10 Condition: S824||Fracture of shaft of fibula, (6) ICD-10 Condition: S825||Fracture of medial malleolus, (7) ICD-10 Condition: S826||Fracture of lateral malleolus, (8) ICD-10 Condition: S829||Unspecified fracture of lower leg,
- Registration Number
- CTRI/2022/05/042633
- Lead Sponsor
- Principal investigator Dr Sonik Shah
- Brief Summary
It is a prospective randomised single blinded control study performed in Operation room.
Intervention: At the time of performing Subarachnoid block, Spinal anaesthesia will be given with either 0.5% Bupivacaine heavy + 4mg Dexamethasone
or
0.5% Bupivacaine heavy + Ketamine 25 mg using standard spinal anaesthesia technique.
Aim:
Primary- To prolong analgesic effect after spinal anaesthesia after completion of surgery and to reduce requiremnt of post operative analgesia.
Secondary-To compare incidence of complications between two gruops.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 64
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: 1 Patient’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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 patient’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. 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 patient’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 Outcome Measures
Name Time Method nausea Vomiting Hypotension Sedation One hourly
Trial Locations
- Locations (1)
Dr N D Desai faculty of medical Science and Research
🇮🇳Kheda, GUJARAT, India
Dr N D Desai faculty of medical Science and Research🇮🇳Kheda, GUJARAT, IndiaDr Sonik ShahPrincipal investigator9979788588drsonik@gmail.com