NCT01938755

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

7 months

First QC Date

September 5, 2013

Last Update Submit

April 3, 2017

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • degree of motor blockade

    until dissolve of motor blockade

Study Arms (3)

levobupivacaine I

EXPERIMENTAL

group that was administered levobupivacaine plus 60mg dextrose

Drug: levobupivacaine

levobupivacaine II

EXPERIMENTAL

group that was administered levobupivacaine plus 80 mg dextrose

Drug: levobupivacaine

levobupivacaine III

EXPERIMENTAL

group that was administered levobupivacaine plus 100 mg dextrose

Drug: levobupivacaine

Interventions

levobupivacaineDRUG

levobupivacaine plus 60 mg dextrose

levobupivacaine I

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Approval to participate in the study and spinal anesthesia
  • American society of anesthesia (ASA) I,II physical status
  • Scheduled for lower extremity surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anestesia and Reanimation Dept.; Ordu University Education and Research Hospital

Ordu, Ordu, 52100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Levobupivacaine

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Özgür Yağan

Study Record Dates

First Submitted

September 5, 2013

First Posted

September 10, 2013

Study Start

June 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

April 5, 2017

Record last verified: 2017-04

Locations

TU(1)