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Completed

NCT Number: NCT07346599

A Block Method for Pain After Back Surgery

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Afyonkarahisar Health Sciences University Hospital

Afyonkarahisar, Merkez, 03000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ESP block group

Procedure

BILATERAL TWO-LEVEL ESP BLOCK WAS APPLIED TO PATIENTS UNDERGOING LUMBAR SPINAL SURGERY.

Primary outcomes

  1. VAS values of patients in the first 24 hours postoperatively

    Time frame: The first 24 hours postoperatively

    Zero indicates no pain, and 10 indicates the worst possible pain

Sponsors and collaborators

Lead sponsor

Kutahya City Hospital

Other

Registry information

Official study title

The Effect of Bilateral Lumbar Erector Spinae Plane Block on Postoperative Analgesia in Lumbar Spinal Surgery

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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