Skip to main content
OpenTrials
Completed

NCT Number: NCT05630404

Efficacy of Surgical Injection Lumbar Erector Spinae Plane Block

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lumbar Spine Instability Bone Diseases Lumbar Spinal Stenosis Lumbar Spine Degeneration Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mursel Ekinci

Bursa, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical ESPB

Drug

In group IE, transverse processes will be palpated before sewing the surgical incision by the surgery team. The local anesthetic solution will be administered after the needle contacts the transverse process and its location is confirmed by negative aspiration. Once the needle tip will be placed within the interfacial plane and after careful aspiration to rule out intravascular needle placement, 5 mL of solution will be injected the proper injection site. Local anesthetic solution will be injected at 4 levels along the surgical incision line. A dose of 0.25% bupivacaine 20 mL will be injected in each side (total 40 mL).

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.

US guided ESPB

Drug

US guided ESP block will be performed. US probe will be placed longitudinally 2-3 cm lateral to the L3 transverse process. Erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle will be inserted cranio caudal direction and then for correction of the needle 2 ml saline will be enjected deep into the erector spina muscle fascia. Following confirmation of the correct position of the needle 20 ml %0.25 bupivacaine will be administered for block in each side (total 40 mL).

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 outcomes

  1. Postoperative opioid consumption

    Time frame: Change from Baseline Opioid Consumption for Postoperative 24 hours.

    Postoperative opioid consumption will be evaluated at postoperative 24 h period

Secondary outcomes

  1. Visual analogue scores (VAS)

    Time frame: postoperative 1, 2, 4, 8, 16 and 24 hours

    VAS score (0 = no pain, 10 = the most severe pain felt)

Sponsors and collaborators

Lead sponsor

Bursa City Hospital

Other Gov

Registry information

Official study title

Efficacy of Surgical Injection Lumbar Erector Spinae Plane Block for Pain Management Following Lumbar Spinal Fusion Surgery

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 29, 2022
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.