Effect of ESPB on Intraoperative Remifentanil Consumption

Effect of ESPB on Intraoperative Remifentanil Consumption in Lumbar Spine Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Erector Spinae Plane Block; Lumbar Spine Surgery; Remifentanil Consumption
• Intervention / Treatment: Drug: Preoperative Erector Spinae Plane Block; Drug: Postoperative Erector Spinae Plane Block

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Musa Zengin, Associate Professor; Phone Number: 00905307716235; Email: musazengin@gmail.com
• Study Contact Backup: Name: Ahmet Atasoy, MD; Phone Number: 00905051466084; Email: ahmetatasoy698@gmail.com

Study Locations

• Turkey
  • Ankara
    • Yenimahalle, Ankara, Turkey, 06170
      • Recruiting
      • Ankara Etlik City Hospital
      • Contact: Musa Zengin, Associate Professor; Phone Number: 00905307716235; Email: musazengin@gmail.com
      • Contact: Deniz Çolak, MD; Phone Number: 00905386519710; Email: doctordenizcolak@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Preoperative Erector Spinae Plane Block; In the preoperative period, under general anesthesia, after the linear ultrasound (US) probe will be placed 2-3 cm lateral to the L3 spinous process, 15 ml of 0.25% bupivacaine will be injected into the interfacial space below the erector spinae muscle, above the transverse process. The same ESPB procedure was performed on the other side. In total, 40 ml of 0.25% bupivacaine was administered.	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.
Active Comparator: Postoperative Erector Spinae Plane Block; In the postoperative period, under general anesthesia, after the linear ultrasound (US) probe will be placed 2-3 cm lateral to the L3 spinous process, 15 ml of 0.25% bupivacaine will be injected into the interfacial space below the erector spinae muscle, above the transverse process. The same ESPB procedure was performed on the other side. In total, 40 ml of 0.25% bupivacaine was administered.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2024
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: February 26, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: AEŞH-EK1-2023-797

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No