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Hyperbaric Levobupivacaine for Spinal Anaesthesia

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ClinicalTrials.gov Identifier: NCT01938755
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
özgür yağan, 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.


Condition or disease Intervention/treatment Phase
This Study Was Focused on Selective Spinal Anesthesia for Lower Extremity Surgery in Order to Achieve Early Mobilization and to Shorten Hospital Stay Drug: levobupivacaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : June 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Arm Intervention/treatment
Experimental: levobupivacaine I
group that was administered levobupivacaine plus 60mg dextrose
Drug: levobupivacaine
levobupivacaine plus 60 mg dextrose

Experimental: levobupivacaine II
group that was administered levobupivacaine plus 80 mg dextrose
Drug: levobupivacaine
levobupivacaine plus 80 mg dextrose

Experimental: levobupivacaine III
group that was administered levobupivacaine plus 100 mg dextrose
Drug: levobupivacaine
levobupivacaine plus 100 mg dextrose




Primary Outcome Measures :
  1. degree of motor blockade [ Time Frame: until dissolve of motor blockade ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938755


Locations
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Turkey
Anestesia and Reanimation Dept.; Ordu University Education and Research Hospital
Ordu, Turkey, 52100
Sponsors and Collaborators
T.C. ORDU ÜNİVERSİTESİ

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Responsible Party: özgür yağan, Özgür Yağan, T.C. ORDU ÜNİVERSİTESİ
ClinicalTrials.gov Identifier: NCT01938755     History of Changes
Other Study ID Numbers: odu52
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
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Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents