Hyperbaric Levobupivacaine for Spinal Anaesthesia
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- degree of motor blockade
Study Overview
Brief Summary
Spinal anaesthesia also called spinal block or sub-arachnoid block (SAB), is a form of regional anaesthesia involving injection of a local anaesthetic into the subarachnoid space, generally through a fine needle.
There is no generic hyperbaric form of levobupivacaine currently available so we aimed in this study that to find the appropriate concentration of the levobupivacaine which achieves unilateral spinal anesthesia. The potential benefits of this type of anesthesia are less motor blockade and urinary retention, decrease in hospital stay. Therefore, it seems to be suitable for outpatient anesthesia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Approval to participate in the study and spinal anesthesia
- •American society of anesthesia (ASA) I,II physical status
- •Scheduled for lower extremity surgery
Exclusion Criteria
- •Refuse to participate in the study
- •American society of anesthesia (ASA)III, IV physical status
- •Hypersensitivity to local anesthetics
- •Emergency surgery
- •Chronic pain treatment
- •Peripheral neuropathy
- •Severe systemic disease
Arms & Interventions
levobupivacaine I
group that was administered levobupivacaine plus 60mg dextrose
Intervention: levobupivacaine (Drug)
levobupivacaine II
group that was administered levobupivacaine plus 80 mg dextrose
Intervention: levobupivacaine (Drug)
levobupivacaine III
group that was administered levobupivacaine plus 100 mg dextrose
Intervention: levobupivacaine (Drug)
Outcomes
Primary Outcomes
degree of motor blockade
Time Frame: until dissolve of motor blockade
Secondary Outcomes
No secondary outcomes reported
Investigators
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