Hyperbaric Levobupivacaine for Spinal Anaesthesia

T.C. ORDU ÜNİVERSİTESİ

Status and phase: Completed; Phase 4

Conditions: This Study Was Focused on Selective Spinal Anesthesia for Lower Extremity Surgery in Order to Achieve Early Mobilization and to Shorten Hospital Stay

Treatments: Drug: levobupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01938755

odu52

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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73 participants in 3 patient groups

levobupivacaine I

Experimental group

Description:

group that was administered levobupivacaine plus 60mg dextrose

Treatment:

Drug: levobupivacaine

Drug: levobupivacaine

Drug: levobupivacaine

levobupivacaine II

Experimental group

Description:

group that was administered levobupivacaine plus 80 mg dextrose

Treatment:

Drug: levobupivacaine

Drug: levobupivacaine

Drug: levobupivacaine

levobupivacaine III

Experimental group

Description:

group that was administered levobupivacaine plus 100 mg dextrose

Treatment:

Drug: levobupivacaine

Drug: levobupivacaine

Drug: levobupivacaine