COMPARING THE EFFECTS OF TWO LOCAL ANAESTHESIA DRUGS FOR SPINAL ANESTHESIA

Not yet recruiting

Conditions: Medical and Surgical, (2) ICD-10 Condition: S828||Other fractures of lower leg,

Registration Number: CTRI/2022/12/048169

Lead Sponsor: M S RAMAIAH MEDICAL COLLEGE

Brief Summary: Subarachnoid block is a popular mode of anaesthesia for lower abdominal as well as lower limb surgeries. It is not associated with disadvantages of general anaesthesia like airway manipulation, usage of multiple drugs, additional supplementary analgesics, postoperative nausea and vomiting. Local anaesthetic drugs such Bupivacaine, Levobupivacaine and Ropivacaine are commonly used for spinal anaesthesia, with Bupivacaine being most common. The advantages being, early onset and prolonged duration of sensory blockade.

Ropivacaine, a newer amide local anaesthetic has many similar properties with Bupivacaine, but with lesser incidence of cardiovascular and central nervous system toxicity. Ropivacaine also has a faster recovery from motor block. Adding adjuvants like Morphine, Fentanyl, Dexmedetomidine to the local anaesthetic increases the duration of action, increases the density of block, decreases the dose requirement thereby also reducing the risk of complications. Fentanyl and Morphine are known to cause side effects like nausea, vomiting and pruritus.

Intrathecal Dexmedetomidine, an alpha 2 receptor agonist as an adjuvant had favourable outcomes. Addition of Dexmedetomidine to Ropivacaine and Bupivacaine for spinal

anaesthesia in parturients has shown to hasten the onset of sensory and motor block, prolong the time of sensory block, improve muscle relaxation, improve intraoperative somatovisceral sensory block characteristics and postoperative analgesia, decrease shivering, with minimal hemodynamic and other side effects.

There is paucity of literature comparing the effect of Dexmedetomidine as an adjuvant to Bupivacaine and Ropivacaine on block characteristics. Hence, the present study has been designed to compare the effects of Dexmedetomidine as an adjuvant with 0.5% hyperbaric Bupivacaine and 0.75% hyperbaric Ropivacaine on onset, duration and recovery from sensory and motor blockade in spinal anaesthesia and also on hemodynamic effect.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

Elective lower limb Orthopedic surgeries.
American Society of Anesthesiologists Physical Status 1 and 2.

Exclusion Criteria

Patients refusal to participate in the study.
Contraindications to Spinal Anaesthesia.
Pregnant women and lactating mothers.
Patient allergic to Opiods and Local Anaesthetic drugs.
Patient height <150cms.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the effect on onset and duration of sensory block and onset and duration of motor block.	The block will be assessed at 1 minute interval for the first 10 minutes, every 5 minutes in the first hour, every 10 minutes till the regression of block.

Secondary Outcome Measures

Name	Time	Method
To compare the effect on hemodynamic changes in both the groups like hypotension, bradycardia and side effects such as nausea, vomiting, pruritius and shivering.	Hemodynamic parameters measured at every 2 minute intervals for the first 10

Trial Locations

Locations (1): M S RAMAIAH MEDICAL COLLEGE
🇮🇳
Bangalore, KARNATAKA, India
M S RAMAIAH MEDICAL COLLEGE
🇮🇳Bangalore, KARNATAKA, India
Dr Geetha C R
Principal investigator
9900482828
jaheedha@gmail.com