Clinical trial NCT05630404: Efficacy of Surgical Injection Lumbar Erector Spinae Plane Block
Official title: Efficacy of Surgical Injection Lumbar Erector Spinae Plane Block for Pain Management Following Lumbar Spinal Fusion Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spine Instability
Lumbar Spinal Stenosis
Lumbar Spine Degeneration
Keywords: Lumbar spinal fusion surgery
Postoperative analgesia
Erector spina plan block
Lead sponsor: Bursa City Hospital
Sponsor class: OTHER_GOV
First posted: 2022-11-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are three models for this study. The first group is ultrasound guided erector spinae plane block group. The second one is surgical injection erector spinae plane block group. The third one is the no intervention control group.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative opioid consumption
timeFrame: Change from Baseline Opioid Consumption for Postoperative 24 hours.
Secondary outcomes:
measure: Visual analogue scores (VAS)
timeFrame: postoperative 1, 2, 4, 8, 16 and 24 hours
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Mursel Ekinci
Study officials:
References:
citation: 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.
citation: Yayik AM, Cesur S, Ozturk F, Ahiskalioglu A, Ay AN, Celik EC, Karaavci NC. Postoperative Analgesic Efficacy of the Ultrasound-Guided Erector Spinae Plane Block in Patients Undergoing Lumbar Spinal Decompression Surgery: A Randomized Controlled Study. World Neurosurg. 2019 Jun;126:e779-e785. doi: 10.1016/j.wneu.2019.02.149. Epub 2019 Mar 8.
citation: Finnerty DT, Buggy DJ. Efficacy of the erector spinae plane (ESP) block for quality of recovery in posterior thoraco-lumbar spinal decompression surgery: study protocol for a randomised controlled trial. Trials. 2021 Feb 17;22(1):150. doi: 10.1186/s13063-021-05101-2.