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

February 25, 2026 updated by: Musa Zengin, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

The Effects of Body Mass Index on Erector Spina Plane Block Analgesia Treatment in Lumbar Disc Herniation Surgery

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Ankara
      • Yenimahalle, Ankara, Turkey (Türkiye), 06170
        • Ankara Etlik City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
Procedure: Erector spinae plane block
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.
Procedure: Erector spinae plane block
Erector spinae plane block will be applied to the patients under real-time ultrasound guidance.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Scores
Time Frame: 1st hour after surgery.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intraoperative remifentanil consumption
Time Frame: During the intraoperative period
The amount of remifentanil that patients need to maintain anesthesia during the intraoperative period will be recorded.
During the intraoperative period
Pain Scores
Time Frame: 2nd hour after surgery.
Pain will be assessed at the 2nd-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
2nd hour after surgery.
Pain Scores
Time Frame: 6th hour after surgery.
Pain will be assessed at the 6th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
6th hour after surgery.
Pain Scores
Time Frame: 12th hour after surgery.
Pain will be assessed at the 12th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
12th hour after surgery.
Pain Scores
Time Frame: 24th hour after surgery.
Pain will be assessed at the 24th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
24th hour after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AEŞH-BADEK-2024-035

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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