Hyperbaric Levobupivacaine for Spinal Anaesthesia

Phase 4

Completed

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

• Registration Number: NCT01938755
• Lead Sponsor: T.C. ORDU ÜNİVERSİTESİ

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-09-05
• Study First Submitted QC: 2013-09-05
• Study First Posted: 2013-09-10
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-03
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
levobupivacaine II	levobupivacaine	group that was administered levobupivacaine plus 80 mg dextrose
levobupivacaine I	levobupivacaine	group that was administered levobupivacaine plus 60mg dextrose
levobupivacaine III	levobupivacaine	group that was administered levobupivacaine plus 100 mg dextrose

Primary Outcome Measures

Name	Time	Method
degree of motor blockade	until dissolve of motor blockade

Trial Locations

Locations (1)

Anestesia and Reanimation Dept.; Ordu University Education and Research Hospital; 🇹🇷 Ordu, Turkey