Erector Spinae Block Versus Local Field Block in Lumbar Spine Surgeries

NCT05570565 | Unknown

• 1 other identifier: N-40-2022
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Major lumbar spine surgeries are associated with significant postoperative pain that may last for days,So In this study, we intend to evaluate if preventive analgesia with a single injection dose of ultrasound guided bilateral erector spinae is a safe and better method of peri-operative analgesia for lumbar spine surgeries than preincisional local field block.

Conditions

Postoperative Pain

Keywords

postoperative pain; Erector spinae plane block; lumbar spine surgery

Outcome Measures

Primary Outcomes (1)

• duration of postoperative analgesia

  Time to first analgesic request

  24 hours

Secondary Outcomes (5)

• cumulative 24 hour opioid consumption

  24 hours

• pain assessment using VAS score at 15minutes, 30 minutes,1,2,4,8,12,24 hours postoperative

  24 hours

• presence of any complications

  evey 10 minutes intraoperative till end of surgery (up to 2 hours)

• patient satisfaction with anesthesia

  24 hours

• surgeon satisfaction for surgical field accessibility

  2 hours

Study Arms (2)

Erector spinae plane group

EXPERIMENTAL

The patient will be in the prone position, after skin sterilization, ESP block will be performed at the level of L3. a curvilinear ultrasound transducer will be placed sagittal 3 cm lateral to L3 spinous process where a hyperechoic shadow of the transverse process (TP) and erector spinae will be defined. A 22-gauge spinal needle will be inserted in cranial to caudal direction toward TP in plane to the ultrasound transducer until the needle touches the TP crossing the whole muscles. The location of the needle tip will be confirmed by visible normal saline solution separating erector spinae muscle off the bony shadow of the TP on ultrasound imaging. After confirming the needle site, 20 mL of local anesthestic mixture of 0.25% bupivacaine and 1%lidocaine adrenaline (1;200000) will be injected. The procedure will be repeated following the same steps on the other side. The surgical intervention will be then allowed 20 minutes after finishing the block procedure

Procedure: Erector spinae plane block

local field block

ACTIVE COMPARATOR

For the preincisional local field block, a 23-gauge needle is used to infiltrate 20mL of local anesthestic mixture of 0.25% bupivacaine and 1%lidocaine adrenaline (1;200000) will be injected in the subcutaneous space and in the paravertebral muscles on each side of the spinous processes of the presumed surgical approach.

Procedure: local field block

Interventions

Erector spinae plane block PROCEDURE

ultrasound guided injection of local anesthestics drugs (mixture of lidocaine and bupivacaine) in the Erector spinae plane which lies between the Erector spinae muscle and lumbar transverse process

Erector spinae plane group

local field block PROCEDURE

infiltration of local anesthestic drugs( mixture of lidocaine and bupivacaine) in the surgical field before surgical incision

local field block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18-65 years old.
• Patients undergoing Lumbar spine surgery (L1-L5).
• American society of anesthesiologists classification (ASA) I and II.
• BMI \< 35
• Duration of surgery less than 3 hours

You may not qualify if:

• Patient's refusal.
• Bleeding disorders (platelets count \< 150,000; INR \>1.5; PC\< 60%) and coagulopathies.
• Skin lesion, wounds or infection at the injection site.
• Known allergy to local anesthetic drugs.
• Chronic opioid users.
• Patients with pre-operative opioid consumption.
• Patients on long term therapy of Corticosteroids

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university hospitals

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Abdelmoneim A Abdelmoneim, lecturer

  Anesthesia department , cairo university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdelmoneim A Abdelmoneim, lecturer

CONTACT

01004392046; abdelmoneim_adel@kasralainy.edu.eg

mohamed A Elshazly, lecturer

CONTACT

01016109777; DR.mohamed.elshazly8686@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 6, 2022
• Study Start: November 10, 2023
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)