Efficacy of Surgical Injection Lumbar Erector Spinae Plane Block

Not Applicable

Completed

• Conditions: Lumbar Spine Instability; Lumbar Spine Degeneration; Lumbar Spinal Stenosis
• Interventions: Drug: Surgical ESPB; Drug: US guided ESPB

• Registration Number: NCT05630404
• Lead Sponsor: Bursa City Hospital

Brief Summary

Lumbar spinal surgery is one of the operations performed for the treatment of leg and back pain. Severe pain may occur at postoperative period in patients following lumbar fusion surgery.

The ultrasound(US) guided erector spina plan block (ESPB) is injected with a local anesthetic into the deep fascia of the erector spinae. Visualization of sonoanatomy with US is simple and the spread of local anesthetic solution can be seen easily the deep fascia of the erector spinae. In the literature, it has been reported that ESPB provides effective analgesia after lumbar spine surgery. The surgical team visualizes the transverse processes and erector spina muscle during surgery.

The aim of this study is to compare US-guided ESPB and surgical infiltrative ESPB for postoperative analgesia management after lumbar spinal fusion surgery.

Detailed Description

Lumbar spinal surgery is one of the operations performed for the treatment of leg and back pain. Severe pain may occur at postoperative period in patients following lumbar fusion surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay, thus complications due to hospitalization such as infection and thromboembolism may be reduced.

Parenteral opioids are generally preferred in the management of acute postoperative pain. However opioids have undesired adverse events such as nausea, vomiting, itching, sedation and respiratory depression (opioid-related adverse events). Regional anesthesia techniques may be preferred as the use of ultrasound (US) increases in daily anesthesia practice.

The ultrasound(US) guided erector spina plan block (ESPB) is injected with a local anesthetic into the deep fascia of the erector spinae. Visualization of sonoanatomy with US is simple and the spread of local anesthetic solution can be seen easily the deep fascia of the erector spinae. In the literature, it has been reported that ESPB provides effective analgesia after lumbar spine surgery. The surgical team visualizes the transverse processes and erector spina muscle during surgery. The erector spina plane block can be performed by administering local anesthetic solution between the transverse process and the erector spina muscle.

The aim of this study is to compare US-guided ESPB and surgical infiltrative ESPB for postoperative analgesia management after lumbar spinal fusion surgery. The primary aim is to compare perioperative and postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting).

Study Timeline

• Study First Submitted: 2022-11-01
• Study Start: 2022-11-28
• Study First Submitted QC: 2022-11-28
• Study First Posted: 2022-11-29
• Primary Completion: 2023-08-15
• Status Verified: 2023-09
• Study Completion: 2023-09-15
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• American Society of Anesthesiologists (ASA) classification I-II
• 2 or 3 levels of posterior lumbar spinal fusion surgery under general anesthesia

Exclusion Criteria

• history of bleeding diathesis
• receiving anticoagulant treatment
• known local anesthetics and opioid allergy
• infection of the skin at the site of the needle puncture
• pregnancy or lactation
• patients who do not accept the procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group IE= Surgical Injection ESPB	Surgical ESPB	Patients will be administered tenoxicam 20 mg IV every 12 hours in the postoperative period. A patient controlled device prepared with 5 mg/ ml tramadol will be attached to all patients with a protocol included 10 mg bolus without infusion dose, 20 min lockout time and 4 hour limit.Tenoxicam 20 mg and a dose of 100 mg tramadol intravenously will be performed to all patients 30 min before the end of the surgery for postoperative analgesia.
Group UE= US guided ESPB	US guided ESPB	Patients will be administered tenoxicam 20 mg IV every 12 hours in the postoperative period. A patient controlled device prepared with 5 mg/ ml tramadol will be attached to all patients with a protocol included 10 mg bolus without infusion dose, 20 min lockout time and 4 hour limit.Tenoxicam 20 mg and a dose of 100 mg tramadol intravenously will be performed to all patients 30 min before the end of the surgery for postoperative analgesia.Tenoxicam 20 mg and a dose of 100 mg tramadol intravenously will be performed to all patients 30 min before the end of the surgery for postoperative analgesia.

Primary Outcome Measures

Name	Time	Method
Postoperative opioid consumption	Change from Baseline Opioid Consumption for Postoperative 24 hours.	Postoperative opioid consumption will be evaluated at postoperative 24 h period

Secondary Outcome Measures

Name	Time	Method
Visual analogue scores (VAS)	postoperative 1, 2, 4, 8, 16 and 24 hours	VAS score (0 = no pain, 10 = the most severe pain felt)

Trial Locations

Locations (1)

Mursel Ekinci; 🇹🇷 Bursa, Turkey