The Effects of Body Mass Index on Erector Spinae Plane Block Analgesia

NCT ID: NCT06257953

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-10
• Study Completion Date: 2024-06-26

Brief Summary

In recent years, obesity has become one of the leading health problems worldwide. It is known that obesity can cause various diseases and negatively impact the quality of life. Therefore, many conditions believed to be affected by obesity and relevant to patients' quality of life have been scientifically investigated and continue to be researched. One of these conditions is postoperative pain, with studies in the literature indicating that postoperative pain levels increase in parallel with each unit increase in BMI.

The incidence of lumbar disc herniation (LDH) is on the rise and adversely affecting the quality of life. The primary surgical intervention for LDH is discectomy. In recent years, various less invasive techniques, such as microdiscectomy, have been described to improve both surgical and analgesic outcomes. However, even with microdiscectomy surgery, postoperative pain may occur, and its control should be well-managed. Inadequate pain control can lead to unwanted effects of postoperative pain. Regional analgesia techniques may be preferred for effective analgesic treatment after spinal surgery. Methods such as paravertebral block, erector spinae plane block (ESPB), thoracolumbar interfascial plane block are widely used for analgesia in spinal surgery. The effectiveness of these regional techniques may vary depending on various factors, one of which is BMI.

The hypothesis in this study is that as BMI increases, the level of pain in patients may also increase. As a result, this study aims to investigate the relationship between BMI and postoperative pain levels in patients undergoing standard LDH surgery, anesthesia, and analgesia.

Conditions

Pain; Pain Postoperative; Pain Acute; Erector Spinae Plane Block; Lumbar Disc Herniation; Body Mass Index

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Patients with a BMI of 18-24.9 kg/m2

Following the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the erector spinae muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 15 ml of 0.25% bupivacaine was injected into the area. Then the block process will be applied to the other side in the same way. A total of 30 ml of 15 ml 0.25% bupivacaine will be injected.

Group Type: ACTIVE_COMPARATOR

Erector spinae plane block

Intervention Type: PROCEDURE

Erector spinae plane block will be applied to the patients under real-time ultrasound guidance.

Patients with a BMI of 25-29.9 kg/m2

Following the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the erector spinae muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 15 ml of 0.25% bupivacaine was injected into the area. Then the block process will be applied to the other side in the same way. A total of 30 ml of 15 ml 0.25% bupivacaine will be injected.

Group Type: ACTIVE_COMPARATOR

Erector spinae plane block

Intervention Type: PROCEDURE

Erector spinae plane block will be applied to the patients under real-time ultrasound guidance.

Patients with a BMI of 30-40 kg/m2

Following the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the erector spinae muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 15 ml of 0.25% bupivacaine was injected into the area. Then the block process will be applied to the other side in the same way. A total of 30 ml of 15 ml 0.25% bupivacaine will be injected.

Group Type: ACTIVE_COMPARATOR

Erector spinae plane block

Intervention Type: PROCEDURE

Erector spinae plane block will be applied to the patients under real-time ultrasound guidance.

Interventions

Erector spinae plane block

Erector spinae plane block will be applied to the patients under real-time ultrasound guidance.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 18 to 65 years old
• ASA physical status I-II-III
• BMI 18 to 40 kg/m2
• Elective LDH surgery

Exclusion Criteria

• Patient refusing the procedure
• Patients who have previously undergone spinal surgery
• Chronic opioid or analgesic use
• Patients who will operate under emergency conditions
• Patients who will not undergo LDH surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Musa Zengin

Principal İnvestigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara Etlik City Hospital

Yenimahalle, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AEŞH-BADEK-2024-035

Identifier Type: -

Identifier Source: org_study_id