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

NCT06257953 | Completed

• 1 other identifier: AEŞH-BADEK-2024-035
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pain Scores

  Pain will be assessed at the first-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at the 1st hour after surgery.

  1st hour after surgery.

Secondary Outcomes (5)

• Pain Scores

  2nd hour after surgery.

• Pain Scores

  6th hour after surgery.

• Pain Scores

  12th hour after surgery.

• Pain Scores

  24th hour after surgery.

• Intraoperative remifentanil consumption

  During the intraoperative period

Study Arms (3)

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.

Procedure: Erector spinae plane block

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.

Procedure: Erector spinae plane block

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.

Procedure: Erector spinae plane block

Interventions

Erector spinae plane block PROCEDURE

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

Patients with a BMI of 18-24.9 kg/m2; Patients with a BMI of 25-29.9 kg/m2; Patients with a BMI of 30-40 kg/m2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This prospective study includes adult patients aged 18 to 65 years with ASA physical status I-III who are scheduled to undergo elective LDH surgery under standardized general anesthesia and bilateral ESPB for postoperative analgesia at Ankara Etlik City Hospital. All participants meet predefined inclusion and exclusion criteria. Patients are categorized into three groups according to their preoperative BMI: 18-24.9 kg/m², 25-29.9 kg/m², and 30-40 kg/m². The study population represents consecutive eligible surgical patients during the study period. No experimental intervention beyond routine anesthetic and analgesic management is introduced; BMI serves as the exposure variable for comparative analysis of analgesic outcomes.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atatürk Chest Diseases and Chest Surgery Training and Research Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Yenimahalle, Ankara, 06170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Pain, Postoperative; Acute Pain; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal İnvestigator

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: January 10, 2024
• Primary Completion: June 10, 2024
• Study Completion: June 26, 2024
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

TU (1)