Effect of ESPB on Intraoperative Remifentanil Consumption

Erector Spinae Plane Block Clinical Trial

Official title:

Effect of ESPB on Intraoperative Remifentanil Consumption in Lumbar Spine Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06303557
• Other study ID #: AESH-EK1-2023-797
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2024
• Est. completion date: December 30, 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, regional anesthesia techniques have also been frequently applied to patients for pain relief. Erector spinae plane block (ESPB), is among the regional anesthesia techniques frequently used in lumbar spine surgery.

General anesthesia (GA) is the main method of anesthesia for lumbar spine surgery. However, GA can only inhibit the projection system of the cortical limbic system or hypothalamic cortex. GA cannot completely block the transmission of peripheral noxious stimulus to the central nervous system and cannot effectively inhibit the intraoperative stress response. With the addition of peripheral blocks such as ESPB, lower remifentanil consumption, and more stable hemodynamics are expected by providing preemptive analgesia in patients.

As a result of all these; it was aimed to compare the intraoperative remifentanil consumption of patients who underwent preoperative ESPB in patients who will undergo lumbar spine surgery resection under GA with those who underwent postoperative ESPB.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18 to 65 years old

• American Society of Anesthesiologists (ASA) physical status I-II-III

• Body mass index 18 to 40 kg/m2

• Elective lumbar disc herniation 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 lumbar disc herniation surgery

Related Conditions & MeSH terms

• Erector Spinae Plane Block
• Lumbar Spine Surgery

Intervention

Drug:
• Preoperative Erector Spinae Plane Block
Erector spinae plane block will be performed bilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, and when the patient is placed in the prone position.
• Postoperative Erector Spinae Plane Block
Erector spinae plane block will be performed unilaterally, under US guidance, after the surgical operation, under general anesthesia, and when the patient is placed in the prone position.

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	Mean arterial pressure	Mean arterial pressure values will be recorded before anesthesia, before surgical incision, after surgical incision at the 5th, 30th, 60th, 90th, 120th minutes, and after general anesthesia.	Perioperative period
Secondary	Heart rate	Heart rate values will be recorded before anesthesia, before surgical incision, after surgical incision at the 5th, 30th, 60th, 90th, 120th minutes, and after general anesthesia.	Perioperative period
Secondary	Pain scores	Pain will be assessed at 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.	First 24 hours after surgery