Hyperbaric Levobupivacaine for Spinal Anaesthesia | NCT01938755

Studies
Hyperbaric Levobupivacaine for Spinal Anaesthesia

NCT01938755

Sponsor

Ordu University

Status

Completed

Last Update Posted

Apr 5, 2017Actual

Enrollment

73Actual

Phase

Phase 4

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

levobupivacaine
levobupivacaine
levobupivacaine

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Sep 5, 2013

First Submission Date that Met QC Criteria

Sep 5, 2013

First Posted Date

Sep 10, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2017

Last Update Posted Date

Apr 5, 2017Actual

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

73Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
levobupivacaine	Drug	levobupivacaine plus 60 mg dextrose	levobupivacaine I

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
degree of motor blockade		until dissolve of motor blockade

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Anestesia and Reanimation Dept.; Ordu University Education and Research Hospital		Ordu	Ordu	52100	Turkey (Türkiye)

Intervention Browse Module

MeSH Terms

ID	Term
D000077554	Levobupivacaine

Ancestor Terms

ID	Term
D002045	Bupivacaine
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided