A Block Method for Pain After Back Surgery

Kutahya City Hospital

Status: Completed

Conditions: Postoperative Pain; Randomised Clinical Trial; Nerve Block

Treatments: Procedure: ESP block group

Study type: Interventional

Funder types: Other

Identifiers

NCT07346599

448

Details and patient eligibility

About

The purpose of this clinical trial is to evaluate whether bilateral lumbar erector spinae plane (ESP) block can reduce postoperative pain in adult patients undergoing lumbar spine surgery. The study also assesses the safety of this method and its effects on the recovery process. The main questions it aims to answer are:

Do patients who receive the ESP block experience less postoperative pain? Do these patients require fewer opioid (morphine-derived) analgesics? Does the first analgesic requirement occur later? Do patients mobilize earlier (stand/walk sooner)? Does the ESP block affect hemodynamic stability during and after surgery? Researchers will compare the ESP block group with the standard analgesia group to determine whether these effects occur.

Participants:

Patients in this study will be asked to:

Be randomly assigned to one of two groups before lumbar spine surgery Receive either a bilateral ESP block or standard analgesic therapy

Undergo postoperative follow-up including:

measurement of pain scores, recording of analgesic consumption, assessment of time to first analgesic requirement, monitoring of mobilization time, valuation of possible side effects

Full description

This randomized controlled study was designed to evaluate the effect of bilateral lumbar erector spinae plane (ESP) block on postoperative analgesia in patients undergoing lumbar spine surgery. A total of 102 patients scheduled for lumbar spine surgery were enrolled in the study and randomly assigned into two groups. One group received a bilateral ESP block at the L2-L4 levels using 20 mL of 0.25% bupivacaine on each side, while the control group received standard postoperative analgesia.

Postoperative pain assessment, opioid consumption, time to first analgesic request, mobilization time, intraoperative hemodynamic parameters, and the occurrence of adverse events were prospectively recorded according to a predefined follow-up protocol. The study was conducted using a prospective, randomized design to assess the efficacy and safety of bilateral lumbar ESP block for postoperative pain management in lumbar spine surgery.

Enrollment: 102 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients aged 18 and over, 80 and under
• American Society of Anesthesiologists Patient Classification Score (ASA) between I and Ⅲ
• Patients who can cooperate and give consent
• No chronic analgesic or opioid use
• No mental or psychiatric disorders
• No alcohol or illicit drug use
• Patients scheduled for elective spinal surgery

Exclusion criteria

• -Patients who withdrew from participation at any time during the study
• Foreign nationals who could not be contacted
• Patients under 18 and over 80
• Patients with an ASA score of Ⅳ or higher
• Patients scheduled for emergency surgery
• Pregnant women and breastfeeding mothers
• Bleeding diathesis
• Drug allergy
• Anticoagulant use
• Local/systemic infection
• Serious arrhythmia

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 2 patient groups

ESP BLOCK,

Active Comparator group

Treatment:

Procedure: ESP block group

CONTROL GROUP

No Intervention group