Comparison between hyperbaric levobupivacaine withbuprenorphine and hyperbaric ropivacaine with buprenorphinefor spinal anesthesia in patients undergoing lower limbsurgery: A prospective randomised study
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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
Ropivacainean 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 µ 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
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
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)
- •Patients with known hypersensitivity to local anaesthetic drugs.
- •Pregnant and lactating women 4.Contraindication to spinal anesthesia (Patient refusal, Coagulopathy, Local infection)
- •Patients diagnosed to have neurological diseases and Musculoskeletal diseases
- •Patients with previous spine surgeries and spine abnormalities.
Outcomes
Primary Outcomes
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
Time Frame: After giving spinal anesthesia
Secondary Outcomes
- 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)