Erector Spinae Plane Block in Spine Surgeries

NCT ID: NCT05247021

Last Updated: 2022-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-22

Study Completion Date

2022-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Aim of this study was to assess the efficacy of erector spinae plane block (ESB) for postoperative pain management in lumbar spine surgery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lumbar Disc Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

erector spinae block group (E)

patients will receive bilateral ultrasound guided erector spinae block before the lumbar spine surgery starts.(20ml of bupivacaine 0.25%) after receiving general anesthesia

Group Type EXPERIMENTAL

erector spinae block for group E

Intervention Type PROCEDURE

. The patient will be placed in the prone position. A high-frequency linear probe or a curved array probe, depending on the BMI of the patient, will be placed in longitudinal alignment, 2-3cm lateral to the vertebral column. The transverse processes of the vertebrae at the level of surgery, the erector spinae muscle, and the psoas muscle will be identified. A 5- or 8-cm 22-G ultrasound needle will be inserted with an in-plane technique in a cephalad-to-caudal direction until bone contact with the top of the transverse process is reached. After slight retraction of the needle, 20ml of bupivacaine 0.25% will be injected behind the erector spinae muscle. The same procedure will be repeated on the contralateral side.

control group (C)

patients will receive standard general anesthesia for lumbar spine surgery according to hospital protocol.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

erector spinae block for group E

. The patient will be placed in the prone position. A high-frequency linear probe or a curved array probe, depending on the BMI of the patient, will be placed in longitudinal alignment, 2-3cm lateral to the vertebral column. The transverse processes of the vertebrae at the level of surgery, the erector spinae muscle, and the psoas muscle will be identified. A 5- or 8-cm 22-G ultrasound needle will be inserted with an in-plane technique in a cephalad-to-caudal direction until bone contact with the top of the transverse process is reached. After slight retraction of the needle, 20ml of bupivacaine 0.25% will be injected behind the erector spinae muscle. The same procedure will be repeated on the contralateral side.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients American Society of Anesthesiologists physical status (ASA) I and II.
* Both sexes.
* Age between 20 to 60 years old.
* Scheduled for lumbar spine surgeries.

Exclusion Criteria

* Patients who received long acting opioids preoperatively.
* Patients with bleeding disorders and coagulopathy.
* Infection at the injection site.
* Allergy to local anesthetics.
* Patients with significant cognitive dysfunction.
* Patients with diabetic neuropathy.
* Patients with uncontrolled hypertension or diabetes.
* Patients with advanced cardiac, respiratory, hepatic or renal disease.
* Patients with viral hepatitis or HIV.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

ossama mansour, professor

Role: STUDY_CHAIR

faculty of medicine , ain shams university

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ain Shams University

Cairo, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

amgad A hamdi, MSc

Role: CONTACT

01002400389 ext. +2

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

amgad A hamdi, MSc

Role: primary

01002400389 ext. +2

amr g sayed, MD

Role: backup

01005013194 ext. +2

References

Explore related publications, articles, or registry entries linked to this study.

Singh S, Choudhary NK, Lalin D, Verma VK. Bilateral Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Randomized Control Trial. J Neurosurg Anesthesiol. 2020 Oct;32(4):330-334. doi: 10.1097/ANA.0000000000000603.

Reference Type BACKGROUND
PMID: 31033625 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ainshmas university

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.