Erector Spinae Plane Block Analgesia for Lumbar Spine Fus... | NCT04749095

Studies
Erector Spinae Plane Block Analgesia for Lumbar Spine Fusion Surgery

NCT04749095

Sponsor

Benha University

Status

Unknown status

Last Update Posted

Feb 11, 2021Actual

Enrollment

45Estimated

Phase

Not Applicable

Conditions

Pain, Postoperative

Interventions

Erector spinae plane block
sham subcutaneous infiltration

Countries

Not provided

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

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2021Estimated

Primary Completion Date

Aug 2021Estimated

Completion Date

Sep 2021Estimated

First Submitted Date

Feb 5, 2021

First Submission Date that Met QC Criteria

Feb 9, 2021

First Posted Date

Feb 11, 2021Actual

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

Feb 9, 2021

Last Update Posted Date

Feb 11, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Baher Said Elshahat Mohamed Abdelhady, Principal Investigator, Benha UniversityPrincipal Investigator

Lead Sponsor

Benha 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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study was to investigate the effect of a bilateral ultrasound guided erector spinae plane block on the pain scores and opoid utiliziation in fusion surgery of the lumbar spine.

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

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Erector block	Active Comparator		Drug: Erector spinae plane block
sham block	Active Comparator		Drug: sham subcutaneous infiltration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Erector spinae plane block	Drug	bilateral ESP block will be injected with 20 ml of 0.25% bupivacaine	Erector block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Analgesia	Numerical rating scale of pain every 6 hours	Up to 24 hours after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society of Anesthesiologists class I-III adult patients
BMI less than or equal 35 kg/m2

Exclusion Criteria:

Patient refusal
unable to give consent
age < 18 or > 65
BMI more than 35 kg/m2
known allergy to the study medication
coagulopathies or on anticoagulant medications
hepatic insufficiency
renal insufficiency
chronic opioid use

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

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