Spinal Anaesthesia comparison with hyperbaric drug in lower limb surgeries

Phase 4

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2023/09/057689

Lead Sponsor: Rajarajeswari medical college and hospital

Brief Summary: Spinal Anaesthesia  is a safe and effective form of anaesthesia widely used in anaesthetic practise as an alternative to general anaesthesia in surgeries that involve lower extremities and infraumbilical region. It provides good anaesthesia,analgesia,motor,sensory blockade but bradycardia and hypotension are its most common side effects. Local anaesthetic bupivacaine is the most commonly used agent at present but it has high cardiac and central nervous system toxicity compared to other agents.1

**Levobupivacaine** which is an S (-)- enantiomer of  bupivacaine is long acting local anesthetic which has with high potency.1 It has less cardiotoxic and central nervous system effects in comparison with both R(+) bupivacaine and bupivacaine. Several studies have been conducted to compare Bupivacaine and Levobupivacaine in various forms and it has been shown that Levobupivacaine has efficacy similar to Bupivacaine  with higher safety profile.2,3

**Ropivacaine**an amino amide local anaesthetic ,is the S-Enantiomer of a bupivacaine, which has low  cardiac toxicity as well as CNS toxicity.It has been found to be less potent than Bupivacaine and Levobupivacaine.1

**Buprenorphine** is an agonist-antagonist opioid which acts as an antagonist at kappa receptor and partial agonist at Âµ receptor. It has been studied as adjuvant in spinal anesthesia.Opioid adjuvants in spinal anesthesia has been shown to enhance to quality of anesthesia and analgesia.4

**Need for study**-After extensive search of literature we found that not many studies has been done in comparing in equipotent doses of levobupivacaine and ropivacaine in spinal anesthesia,hence we are doing this study to compare the same, more over due to better safety profile levobupivacaine has good prospects in replacing in bupivacaine as a drug of choice for spinal anesthesia.1

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

ASA I and II patients of either sex undergoing elective lower limb surgeries.2.Patients aged between 20 to 60 years.

Exclusion Criteria

Patients with bradycardia.(HR less than 50) 2.
Patients with known hypersensitivity to local anaesthetic drugs.
Pregnant and lactating women 4.Contraindication to spinal anesthesia (Patient refusal, Coagulopathy, Local infection) 5.
Patients diagnosed to have neurological diseases and Musculoskeletal diseases 6.
Patients with previous spine surgeries and spine abnormalities.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare onset of sensory blockade between intrathecal 0.5%(H) Levobupivacaine with Buprenorphine and 0.75%(H) Ropivacaine with Buprenorphine in Lower limb surgeries	After giving spinal anesthesia

Secondary Outcome Measures

Name	Time	Method
To compare side effects between intrathecal 0.5%(H) Levobupivacaine with Buprenorphine & 0.75%(H) Ropivacaine with Buprenorphine in Lower limb surgeries	After giving spinal anesthesia
To compare onset of motor blockade between intrathecal 0.5%(H) Levobupivacaine with Buprenorphine & 0.75%(H) Ropivacaine with Buprenorphine in Lower limb surgeries	After giving spinal anaesthesia
To compare hemodynamic changes between intrathecal 0.5%(H) Levobupivacaine with Buprenorphine & 0.75%(H) Ropivacaine with Buprenorphine in Lower limb surgeries	During & after surgery
To compare duration of sensory blockade between intrathecal 0.5% (H) Levobupivacaine with buprenorphine & 0.75% (H) Ropivacaine with buprenorphine in lower limb surgeries	During surgery
To compare duration of analgesia between intrathecal 0.5% (H) levobupivacaine with buprenorphine & 0.75% (H) ropivacaine with buprenorphine in lower limb surgeries	During & after surgery

Trial Locations

Locations (1): Rajarajeswari medical college and hospital
🇮🇳
Bangalore, KARNATAKA, India
Rajarajeswari medical college and hospital
🇮🇳Bangalore, KARNATAKA, India
Dr NAVANEETHAN N K
Principal investigator
9444960258
navaneethan.karthikeyan@gmail.com