To compare the effect of two different drugs added to local anaesthetic drug given for spinal anaesthesia in patients undergoing orthopedic lower limb surgeries

Phase 1

Not yet recruiting

• Conditions: Injuries to the knee and lower leg, (2) ICD-10 Condition: S90-S99||Injuries to the ankle and foot, (3) ICD-10 Condition: S70-S79||Injuries to the hip and thigh,

• Registration Number: CTRI/2021/09/036529
• Lead Sponsor: Dr Shraddha Patil

Brief Summary

A double blind randomized control study conducted to compare intrathecal dexmedetomidine and fentanyl as adjuvant to hyperbaric bupivacaine in orthopedic lower limb surgeries done under spinal anesthesia.

64 patients divided into 2 groups with 32 each, first group( group D) will receive 5mcg dexmedetomidine added to 2.5ml of 0.5% hyperbaric bupivacaine and next group( group F) will receive 25mcg fentanyl added to 2.5 ml of 0.5% hyperbaric bupivacaine intrathecally.

Both sensory and motor status of patient will be assessed immediately after spinal injection, then every 2 minutes until reaching highest sensory level and Bromage scale 3. Then assessed every 10 minute till 2 segment sensory regression is seen. Then assessed every 20 minutes till sensory regression to S1 and Bromage 0.

Severity of pain 2 and 4 hours after surgery will be measured by numeric rating scale(NRS).

Time for 2 segment regression is more in group D than in group F patients

We are also expecting longer duration sensory and motor blockade and longer post operative analgesia in group D patients

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-09-14
• Study Start: 2021-09-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Patients belonging to ASA physical status 1 and 2 Patients giving informed valid written consent Patients undergoing elective orthopedic lower limb surgeries under spinal anaesthesia.

Exclusion Criteria

Patients posted for emergency surgeries Patients having uncontrolled hypertension or diabetes mellitus Patients with renal or hepatic failure, cardiac block or dysrhythmia, coagulopathies, neurologic disorders Patients having hypersensitivity to any of the study groups Patients with known contraindications to spinal anaesthesia.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare time of two segment regression from highest sensory level(min) with Dexmedetomidine and Fentanyl as adjuvant to Hyperbaric Bupivacaine intrathecally in orthopedic lower limb surgeries	after injecting drug sensory and motor status assessed every 2min till it reaches highest sensory level and bromage 3, then every 10min till 2segment regression, then every 20min till it regresses to S1 sensory level and bromage 0

Secondary Outcome Measures

Name	Time	Method
to compare characteristics of block between 2 groups in view of	1.time from injection to highest sensory level

Trial Locations

Locations (1)

Karnataka Institute of Medical Sciences, Hubballi; 🇮🇳 Dharwad, KARNATAKA, India

Karnataka Institute of Medical Sciences, Hubballi

🇮🇳Dharwad, KARNATAKA, India

Dr Shraddha Patil

Principal investigator

9480779235

shraddha.p77@gmail.com