Efficacy of Surgical Injection Lumbar Erector Spinae Plane Block

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-28

Study Completion Date

2023-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sacral Erector Spinae Plane Block(ESPB) in Lumbar Discectomy

NCT06028100

Pain Management

COMPLETED NA

Erector Spinae Plane Block in Spine Surgeries

NCT05247021

Lumbar Disc Disease

UNKNOWN PHASE4

Effectiveness of Bilateral Ultrasound-Guided Erector Spinae Plane Block

NCT04110210

Erector Spinae Plane Block

COMPLETED EARLY_PHASE1

Intraoperative Placement of Superficial Erector Spinae Plane Block; A New Approach in Spine Surgery

NCT05244031

Postoperative Pain Spine Deformity Spine Injury +2 more

COMPLETED NA

Erector Spina Plane Block for Multilevel Major Spinal Surgery

NCT05983393

Pain Post Operative Pain

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lumbar Spine Instability Lumbar Spinal Stenosis Lumbar Spine Degeneration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

The patient, investigators and the pain nurse who performs postoperative pain evaluation will not know the group.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group IE= Surgical Injection 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 Type ACTIVE_COMPARATOR

Surgical ESPB

Intervention Type 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.

Group UE= 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.

Group Type ACTIVE_COMPARATOR

US guided ESPB

Intervention Type 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.

Group C = Control group

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Surgical ESPB

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.

Intervention Type DRUG

US guided ESPB

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No