NCT07514806

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

Estimation of Intraoperative Anaesthetic Drug Requirement in General Anaesthesia With or Without Erector Spinae Plane Block in Lumbar Spondylolisthesis Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Bangladesh Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is designed as a quasi-experimental trial to investigate the efficacy of the ultrasound-guided erector spinae plane (ESP) block in combination with general anesthesia for postoperative pain management in patients undergoing lumbar spondylolisthesis surgery. This clinical trial will recruit 50 adult patients scheduled for elective lumbar spine surgery, who are assigned to either the intervention or control group. Intervention Group (Group B): Patients will receive ultrasound-guided ESP block as an adjunct to standard general anesthesia. Control Group (Group A): Patients will receive general anesthesia without the erector spinae plane (ESP) block. The trial will evaluate pain control (measured by Visual Analogue Scale \[VAS\] scores), opioid consumption, and hemodynamic parameters (such as heart rate, blood pressure, and oxygen saturation). Additionally, postoperative recovery quality, the incidence of adverse events, and any potential complications associated with the erector spinae plane (ESP) block will be monitored and compared between groups. This trial also aims to assess whether the use of the erector spinae plane (ESP) block can reduce opioid consumption, improve hemodynamic stability, and enhance recovery quality in the postoperative period. The study will be conducted at Bangladesh Medical University (BMU), Dhaka, with all ethical considerations adhered to, and informed consent will be obtained from all participants before enrollment. Participants will be followed for 24 hours post-surgery, with monitoring at several time points to assess the primary and secondary outcomes. The results of this study are expected to provide valuable insights into the effectiveness of the erector spinae plane (ESP block) in improving surgical outcomes, reducing opioid use, and enhancing recovery after lumbar spine surgery.

Conditions

• Spondylolisthesis
• Analgesia, Postoperative
• ESPB

Interventions

Type	Name	Description
PROCEDURE	Control Group: General Anesthesia Without Erector Spinae Plane Block	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.
PROCEDURE	Intervention Group: General Anesthesia With Ultrasound-Guided Erector Spinae Plane Block	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.

Timeline

• Start date: 2024-06-01
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2026-04-07
• Last updated: 2026-04-09

Locations

1 site across 1 country: Bangladesh