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Clinical Trials/NCT01938755
NCT01938755
Completed
Phase 4

Hyperbaric Levobupivacaine for Spinal Anaesthesia

T.C. ORDU ÜNİVERSİTESİ1 site in 1 country73 target enrollmentJune 2013
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ConditionsThis Study Was Focused on Selective Spinal Anesthesia for Lower Extremity Surgery in Order to Achieve Early Mobilization and to Shorten Hospital Stay
Interventionslevobupivacaine
Drugslevobupivacaine

Overview

Phase
Phase 4
Intervention
levobupivacaine
Conditions
This Study Was Focused on Selective Spinal Anesthesia for Lower Extremity Surgery in Order to Achieve Early Mobilization and to Shorten Hospital Stay
Sponsor
T.C. ORDU ÜNİVERSİTESİ
Enrollment
73
Locations
1
Primary Endpoint
degree of motor blockade
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
January 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
T.C. ORDU ÜNİVERSİTESİ
Responsible Party
Principal Investigator
Principal Investigator

özgür yağan

Özgür Yağan

T.C. ORDU ÜNİVERSİTESİ

Eligibility Criteria

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

levobupivacaine II

group that was administered levobupivacaine plus 80 mg dextrose

Intervention: levobupivacaine

levobupivacaine III

group that was administered levobupivacaine plus 100 mg dextrose

Intervention: levobupivacaine

Outcomes

Primary Outcomes

degree of motor blockade

Time Frame: until dissolve of motor blockade

Study Sites (1)

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