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NCT Number: NCT06257953

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erector Spinae Plane Block

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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.

Sponsors and collaborators

Lead sponsor

Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 14, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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