A Block Method for Pain After Back Surgery

January 7, 2026 updated by: MERVE KAYNAK, Kutahya City Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Merkez
      • Afyonkarahisar, Merkez, Turkey (Türkiye), 03000
        • Afyonkarahisar Health Sciences University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: CONTROL GROUP
Active Comparator: ESP BLOCK,
Procedure: ESP block group
BILATERAL TWO-LEVEL ESP BLOCK WAS APPLIED TO PATIENTS UNDERGOING LUMBAR SPINAL SURGERY.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The first 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kutahya City Hospital

Investigators

  • Principal Investigator: merve kaynak, Kutahya City Hospital
  • Study Chair: Ali Kaynak, Kutahya City Hospital
  • Study Chair: bilal a bezen, Afyonkarahisar Health Sciences University Hospital
  • Study Director: remziye sıvacı, Afyonkarahisar Health Sciences University Hospital
  • Study Chair: elif d bakı, Afyonkarahisar Health Sciences University Hospital
  • Study Chair: serhat yıldızhan, Afyonkarahisar Health Sciences University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2021

Primary Completion (Actual)

May 20, 2022

Study Completion (Actual)

May 20, 2022

Study Registration Dates

First Submitted

December 9, 2025

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 448

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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