Comparison between two adjuvants used in Spinal Anaesthesia in patients undergoing lower limb orthopaedic surgeries

Phase 4

• Conditions: Health Condition 1: O- Medical and Surgical

• Registration Number: CTRI/2024/02/062984
• Lead Sponsor: College of Medicine and Sagore Dutta Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. patients undergoing elective lower limb orthopaedic surgeries under spinal anaesthesia

2. patients who have given written informed consent to participate in the study

3. ASA grade 1 and 2

Exclusion Criteria

1. Patient with any contraindication to spinal anaesthesia

2. Patients with known allergies to the drugs used

3. Infection at the site of injection

4. Coagulopathy, any coagulopathy disorder or patients on anti-coagulants

5. Pre-existing neurological disease, psychological trouble, endocrinal disease

6. Morbid obesity

7. failure of spinal blockade

8.Patients with previous spinal surgery, kyphoscoliosis or any spinal deformity

9.Pregnancy

10. Patient undergone any other clinical trial within 03 months

11.Patients having hypersensitivity to the drugs used in study

12. History of any any neurological disease like GB Syndrome, subacute combined degeneration of spinal cord

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the depth of analgesia between the two groups of adjuvant drugs given in spinal anaesthesia (using Visual Analogue Scale score for pain) with intrathecal Bupivacaine 0.5% plus DEXMEDETOMIDINE vs. intrathecal Bupivacaine 0.5% plus DEXAMETHASONE in post-operative period in elective lower limb orthopaedic surgery.Timepoint: visual analogue scale score for pain will be used to measure pain postoperatively every 15 minute interval for first 240 minutes then every hourly for next 480 minutes

Secondary Outcome Measures

Name	Time	Method
to compare side effects between the two groups of adjuvant drugs in spinal anaesthesia with injection hyperbaric Bupivacaine with Dexamethasone versus Injection <br/ ><br> hyperbaric Bupivacaine with injection Dexmedetomidine in patients undergoing lower limb orthopaedic surgeriesTimepoint: monitoring for side effects will be done post operatively every 15 minutes for first 240 minutes & then every hourly for next 480 minutes