A Block Method for Pain After Back Surgery

NCT07346599 | Completed

• 1 other identifier: 448
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nerve Block; Postoperative Pain; Randomised Clinical Trial

Keywords

POSTOPERATİVE PAİN; ERECTOR SPİNA PLANE BLOCK; LUMBAR SPİNAL SURGERY

Outcome Measures

Primary Outcomes (1)

• VAS values of patients in the first 24 hours postoperatively

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

  The first 24 hours postoperatively

Study Arms (2)

ESP BLOCK,

ACTIVE COMPARATOR

Procedure: ESP block group

CONTROL GROUP

NO INTERVENTION

Interventions

ESP block group PROCEDURE

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

ESP BLOCK,

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kutahya City Hospital: lead

Study Sites (1)

Afyonkarahisar Health Sciences University Hospital

Afyonkarahisar, Merkez, 03000, Turkey (Türkiye)

Location

Related Publications (4)

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 BACKGROUND

• Goel VK, Chandramohan M, Murugan C, Shetty AP, Subramanian B, Kanna RM, Rajasekaran S. Clinical efficacy of ultrasound guided bilateral erector spinae block for single-level lumbar fusion surgery: a prospective, randomized, case-control study. Spine J. 2021 Nov;21(11):1873-1880. doi: 10.1016/j.spinee.2021.06.015. Epub 2021 Jun 23.

  PMID: 34171466 RESULT

• Tseng V, Xu JL. Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: Is There a Better Option? J Neurosurg Anesthesiol. 2021 Jan;33(1):92. doi: 10.1097/ANA.0000000000000631. No abstract available.

  PMID: 31343504 RESULT

• Liu H, Zhu J, Wen J, Fu Q. Ultrasound-guided erector spinae plane block for postoperative short-term outcomes in lumbar spine surgery: A meta-analysis and systematic review. Medicine (Baltimore). 2023 Feb 17;102(7):e32981. doi: 10.1097/MD.0000000000032981.

  PMID: 36800574 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• merve kaynak

  Kütahya City Hospital

  PRINCIPAL INVESTIGATOR

• Ali Kaynak

  Kütahya City Hospital

  STUDY CHAIR

• bilal a bezen

  Afyonkarahisar Health Sciences University Hospital

  STUDY CHAIR

• remziye sıvacı

  Afyonkarahisar Health Sciences University Hospital

  STUDY DIRECTOR

• elif d bakı

  Afyonkarahisar Health Sciences University Hospital

  STUDY CHAIR

• serhat yıldızhan

  Afyonkarahisar Health Sciences University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist doctor

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 16, 2026
• Study Start: September 27, 2021
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

TU (1)