Ultrasound Guided Erector Spinae Plane Block Versus Retro... | NCT05705739

Studies
Ultrasound Guided Erector Spinae Plane Block Versus Retrolaminar Plane Block

NCT05705739

Sponsor

Minia University

Status

Completed

Last Update Posted

Oct 13, 2023Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Post Operative Pain
Analgesia

Interventions

retrolaminar block
ESPB

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

Oct 2023

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

Feb 10, 2023Actual

Primary Completion Date

Jul 1, 2023Actual

Completion Date

Aug 1, 2023Actual

First Submitted Date

Jan 20, 2023

First Submission Date that Met QC Criteria

Jan 20, 2023

First Posted Date

Jan 31, 2023Actual

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

Oct 12, 2023

Last Update Posted Date

Oct 13, 2023Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Retrolaminar block (RLB) and erector spinae plane block (ESPB) are alternative approaches to paravertebral block (PVB) and are advantageous in that they are easier and safer techniques compared with the traditional PVB. These blocks are considered to be compartment blocks or interfascial plane blocks. In these approaches, local anesthetics are assumed to penetrate the superior costotransverse ligament and reach the paravertebral space, although the needle tip is not advanced into the paravertebral space.

the study aim to evaluate and compare the analgesic efficacy of retrolaminar plane block and erector spinae plane block.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Retrolaminar plane block	Experimental		Procedure: retrolaminar block
ESPB	Experimental		Procedure: ESPB

Interventions

Name	Type	Description	Arm Group Labels	Other Names
retrolaminar block	Procedure	curved probe will be placed 1-1.5 cm lateral to the target spinous process after identification of the lamina, the needle will be advanced caudally until it contacts the lamina

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual analogue pain scale	score from 0-10 (0 mean no pain and 10 the worst pain )	24 hour

Secondary Outcomes

Measure	Description	Time Frame
Time of first post operative analgesic request.	time to demand rescue analgesia	24 hour
Total analgesic consumption	total fentanyl consumption during the first day postoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age18-60.
Both genders.
hepatobiliary surgery.
ASA I-III.

Exclusion Criteria:

Drug allergy.
Morbid obesity (BMI >40 kg/m2).
Psychiatric disorder.
Opiod dependence.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

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
Minia University		Minya	Minya Governorate	61511	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D000377	Agnosia

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided