Ultrasound-Guided Erector Spinae Plane Block for Postoperative Pain Control in Lumbar Spondylolisthesis Surgery

NCT07514806 | Completed DMC

• 1 other identifier: 4975
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to evaluate the effectiveness of ultrasound-guided erector spinae plane (ESP) block as an adjunct to general anesthesia for managing postoperative pain in patients undergoing lumbar spondylolisthesis surgery. The study will compare two groups: one receiving general anesthesia with ESP block (intervention group) and the other receiving general anesthesia alone (control group). The primary objective is to assess postoperative pain relief, opioid consumption, and hemodynamic stability. Secondary outcomes include adverse events and recovery quality. This trial will provide valuable insights into the efficacy of ESP block in improving recovery outcomes and reducing opioid use in spine surgery patients.

Conditions

Analgesia, Postoperative; ESPB; Spondylolisthesis

Keywords

anaesthetic drug requirement; lumber spondylolisthesis surgery; Erector Spinae Plane Block

Outcome Measures

Primary Outcomes (3)

• Intraoperative Opioid Requirements (Fentanyl in micrograms)

  The total amount of opioid (fentanyl in microgram) administered during surgery. The goal is to evaluate the opioid consumption required to maintain adequate analgesia during the procedure.

  Throughout the duration of surgery.

• Intraoperative Inhalational Anaesthetic (Isoflurane in ml/hour) Agent Requirements

  Description: The total consumption of inhalational anesthetic agents (Isoflurane in ml/hour) during the surgical procedure. This measure will help assess the inhalational anaesthetic requirement between groups.

  Throughout the duration of surgery

• Intraoperative Muscle Relaxant (vecuronium in mg) Requirements

  The total dose of muscle relaxant (vecuronium, in mg) is administered to maintain muscle relaxation during surgery. This will be compared between the two groups.

  Throughout the duration of surgery

Secondary Outcomes (4)

• Intraoperative heart rate (HR)

  Recorded at 15-minute intervals during the surgery

• Intraoperative Systolic Blood Pressure (mmHg)

  Recorded at 15-minute intervals during the surgery

• Intraoperative diastolic blood pressure (mmHg)

  Recorded at 15-minute intervals during the surgery

• Intraoperative Mean Arterial Pressure (mmHg)

  Recorded at 15-minute intervals during the surgery

Study Arms (2)

Control Group: General Anesthesia Without Erector Spinae Plane Block

ACTIVE COMPARATOR

Control Group: General Anesthesia Without Erector Spinae Plane Block In this group, patients will receive standard general anesthesia without the addition of an ultrasound-guided erector spinae plane (ESP) block. This arm will serve as the comparison group to assess the impact of the ESP block on postoperative pain and recovery outcomes.

Procedure: Control Group: General Anesthesia Without Erector Spinae Plane Block

Intervention Group: General Anesthesia With Ultrasound-Guided Erector Spinae Plane Block

EXPERIMENTAL

Intervention Group: General Anaesthesia With Ultrasound-Guided Erector Spinae Plane (ESP) Block In this group, patients will receive general anaesthesia in combination with an ultrasound-guided erector spinae plane block. The aim is to evaluate whether adding the ESP block improves postoperative pain control, reduces opioid consumption, and enhances hemodynamic stability during and after lumbar spondylolisthesis surgery.

Procedure: Intervention Group: General Anesthesia With Ultrasound-Guided Erector Spinae Plane Block

Interventions

Control Group: General Anesthesia Without Erector Spinae Plane Block PROCEDURE

Intervention Type: Drug - General Anesthesia Description: Patients will receive general anesthesia using standard anesthetic agents (e.g., propofol, fentanyl, and isoflurane) without the addition of a regional block. No erector spinae plane (ESP) block will be performed.

Control Group: General Anesthesia Without Erector Spinae Plane Block

Intervention Group: General Anesthesia With Ultrasound-Guided Erector Spinae Plane Block PROCEDURE

Description: Patients will receive general anesthesia in combination with an ultrasound-guided erector spinae plane (ESP) block. The ESP block will be performed at the L3-L5 vertebral level using a 22-gauge needle, with 20 mL of 0.25% bupivacaine and 5 mg dexamethasone administered bilaterally under sterile conditions.

Intervention Group: General Anesthesia With Ultrasound-Guided Erector Spinae Plane Block

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient undergoing lumbar spondylolisthesis surgery.
• Elective procedures.
• Age between 18 to 64 years.
• American Society of Anaesthesiologists (ASA) physical status 1 and 2.

You may not qualify if:

• Patient refusal.
• Body Mass Index (BMI) \>35 kg/m2
• Coagulopathy or bleeding disorders.
• Allergy to any of the study drugs.
• Substance abuse or dependence or previous history of opioid addiction.
• Patients with central nervous system disease, severe cardiovascular system disease, hepatic disease or renal disease.
• Local infection or inflammation at the site of block placement.

Sponsors & Collaborators

• Bangladesh Medical University: lead

Study Sites (1)

Bangladesh Medical University

Dhaka, 1000, Bangladesh

Location

Related Publications (52)

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Related Links

• Related Info

MeSH Terms

Conditions

Spondylolisthesis; Agnosia

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• AKM Akhtaruzzaman, MD

  Bangladesh Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 7, 2026
• Study Start: June 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)