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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06257953
• Other study ID #: AESH-BADEK-2024-035
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2024
• Est. completion date: July 10, 2024

Study information

• Verified date: May 2024
• Source: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
• Contact: Musa Zengin, Associate Professor
• Phone: 00905307716235
• Email: musazengin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: July 10, 2024
• Est. primary completion date: June 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Mass Index
• Erector Spinae Plane Block
• Hernia
• Intervertebral Disc Displacement
• Lumbar Disc Herniation
• Pain
• Pain Acute
• Pain Postoperative
• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
Turkey	Ankara Etlik City Hospital	Yenimahalle	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative remifentanil consumption	The amount of remifentanil that patients need to maintain anesthesia during the intraoperative period will be recorded.	During the intraoperative period
Secondary	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, 2nd, 6th, 12th, and 24th hours after surgery.	1st hour after surgery.
Secondary	Pain Scores	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.
Secondary	Pain Scores	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.
Secondary	Pain Scores	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.
Secondary	Pain Scores	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.