Erector Spinae Plane Block in Spine Surgeries

Lumbar Disc Disease Clinical Trial

— ESB  

Official title:

Bilateral Ultrasound Guided Erector Spinae Plane Block for Postoperative Pain Management in Lumbar Spine Surgery ( a Controlled Study Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05247021
• Other study ID #: ainshmas university
• Status: Recruiting
• Phase: Phase 4
• Start date: January 22, 2021
• Est. completion date: June 2022

Study information

• Verified date: December 2021
• Source: Ain Shams University
• Contact: amgad A hamdi, MSc
• Phone: 01002400389
• Email: amgadhamdi[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: June 2022
• Est. primary completion date: April 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lumbar Disc Disease

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the postoperative 24 hours morphine consumption	the analgesic effect of erector spine block will be assessed postoperative by numeric rating scale (NRS), if NRS is more than 3 the patient will receive a rescue dose of 5 milligrams of morphine	24 hours postoperative
Secondary	Mean Blood pressure in mmHg	Measure mean blood pressure of patients postoperative every 4 hours	24 hours postoperative
Secondary	Heart rate	Measure heart of the patients postoperative every 4 hours	24 hours postoperative
Secondary	Patient satisfaction	Measure patient satisfaction by asking the patient if he is satisfied or not " yes or no"	24 hours postoperative
Secondary	First time of mobilization to a chair	Measure the time to first mobilization to a chair in minutes	24 hours postoperative