Erector Spinae Plane Block Analgesia for Lumbar Spine Fusion Surgery

Sponsor

Benha University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04749095

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Drug: Erector spinae plane block Drug: sham subcutaneous infiltration	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

Can Bilateral Erector Spinae Plane Block Minimize Perioprative Opioid Consumption and Provide Satisfactory Analgesia for Lumbar Spine Fusion Surgery? A Randomized Controlled Study

Anticipated Study Start Date :

May 1, 2021

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Erector block	Drug: Erector spinae plane block bilateral ESP block will be injected with 20 ml of 0.25% bupivacaine
Active Comparator: sham block	Drug: sham subcutaneous infiltration bilateral ESP block will be injected with 20 ml of normal saline

Arm

Intervention/Treatment

Active Comparator: Erector block

Drug: Erector spinae plane block

bilateral ESP block will be injected with 20 ml of 0.25% bupivacaine

Active Comparator: sham block

Drug: sham subcutaneous infiltration

bilateral ESP block will be injected with 20 ml of normal saline

Outcome Measures

Primary Outcome Measures

Analgesia [Up to 24 hours after surgery]
Numerical rating scale of pain every 6 hours

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Benha University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Baher Said Elshahat Mohamed Abdelhady, Principal Investigator, Benha University

ClinicalTrials.gov Identifier:

NCT04749095

Other Study ID Numbers:

erector spinae plane block

First Posted:

Feb 11, 2021

Last Update Posted:

Feb 11, 2021

Last Verified:

Feb 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Feb 11, 2021