Hyperbaric Levobupivacaine for Spinal Anaesthesia

April 3, 2017 updated by: özgür yağan, T.C. ORDU ÜNİVERSİTESİ

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ordu, Turkey, 52100
        • Anestesia and Reanimation Dept.; Ordu University Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: levobupivacaine I
group that was administered levobupivacaine plus 60mg dextrose
Drug: levobupivacaine
levobupivacaine plus 60 mg dextrose
Drug: levobupivacaine
levobupivacaine plus 80 mg dextrose
Drug: levobupivacaine
levobupivacaine plus 100 mg dextrose
Experimental: levobupivacaine II
group that was administered levobupivacaine plus 80 mg dextrose
Drug: levobupivacaine
levobupivacaine plus 60 mg dextrose
Drug: levobupivacaine
levobupivacaine plus 80 mg dextrose
Drug: levobupivacaine
levobupivacaine plus 100 mg dextrose
Experimental: levobupivacaine III
group that was administered levobupivacaine plus 100 mg dextrose
Drug: levobupivacaine
levobupivacaine plus 60 mg dextrose
Drug: levobupivacaine
levobupivacaine plus 80 mg dextrose
Drug: levobupivacaine
levobupivacaine plus 100 mg dextrose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
degree of motor blockade
Time Frame: until dissolve of motor blockade
until dissolve of motor blockade

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

T.C. ORDU ÜNİVERSİTESİ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

September 5, 2013

First Submitted That Met QC Criteria

September 5, 2013

First Posted (Estimate)

September 10, 2013

Study Record Updates

Last Update Posted (Actual)

April 5, 2017

Last Update Submitted That Met QC Criteria

April 3, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • odu52

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on levobupivacaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe