Evaluation of Thoracolumbar Interfascial Plane Block for... | NCT03285282

Studies
Evaluation of Thoracolumbar Interfascial Plane Block for Postoperative Analgesia After Herniated Lumbar Disc Surgery

NCT03285282

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Sep 18, 2017Actual

Enrollment

80Estimated

Phase

Early Phase 1

Conditions

Postoperative Analgesia After Disc Surgery

Interventions

Thoracolumber interfascial plane block

Countries

Egypt

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

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 8, 2017Actual

Primary Completion Date

Oct 2017Estimated

Completion Date

Nov 2017Estimated

First Submitted Date

Sep 14, 2017

First Submission Date that Met QC Criteria

Sep 14, 2017

First Posted Date

Sep 18, 2017Actual

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

Sep 14, 2017

Last Update Posted Date

Sep 18, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mona Ammar, Lecture of anesthesia,intensive care and pain management, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Several regional anesthesia have been shown to improve postoperative outcomes in many studies. The transversus abdominis plane (TAP) block provides anesthesia to the abdominal wall by introducing local anesthetic to the anterior rami of the spinal nerve roots. This work evaluates the analgesic effects gained after performing thoracolumbar interfacial plane block (analogous to the TAP block but intended for the back) which targets the sensory component of the dorsal rami of the thoracolumbar nerves in patients undergoing back surgeries.

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Active Comparator	Thoracolumber interfascial plane block	Procedure: Thoracolumber interfascial plane block
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thoracolumber interfascial plane block	Procedure	Thoracolumber interfascial plane block versus placebo	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual Analogue Score		24 hrs postoperative

Secondary Outcomes

Measure	Description	Time Frame
Total morphine consumption		24 hrs postoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with ASA 1 or 2 aged between 21years old up to 60 years old of both sex scheduled of back surgery

Exclusion Criteria:

Exclusion criteria will be patients refusal or inability to give an informed consent , history of relevant allergy to any of the drugs used in the procedure , previous lumbar spine surgery or back surgery with planed spinal fixation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mona Ammar, MD	Contact	01006236620		Mona_3mmar@Hotmail.com
Mohamed Taeimah, MD	Contact

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of medicine	Recruiting	Cairo		1234	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided