Skip to main content
OpenTrials
Completed

NCT Number: NCT05244031

Intraoperative Placement of Superficial Erector Spinae Plane Block; A New Approach in Spine Surgery

Major spine surgery causes severe postoperative pain. The primary objective of this randomized controlled study is to compare the effect of ultrasound (US)-guided superficial erector spinae plane (ESP) block on 48-hour postoperative cumulative opioid requirements with standard (opioid-based) analgesia.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Pain Back Injuries Fractures, Bone Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Spinal Fractures Spinal Injuries Spine Deformity Spine Fracture Spine Injury Spine Malformation Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Istanbul, Bakirkoy, 34147, Turkey (Türkiye)

About this study

46 patients (ASA I-II-III) between 18 and 65 years of age, who were to undergo spine surgery, were randomized and divided into two groups. (23 patients in each of the control and superficial ESP groups). Superficial ESP block was performed for SESP group and standard (opioid-based) analgesia performed in the control group. Postoperative analgesia was provided by intravenous morphine infusion using a patient-controlled analgesia device. Postoperative numeric rating scale values were the primary outcome measure. 24-hour total morphine consumption was secondary outcome measure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ages of 18-65
  • Patients who will undergo spine surgery (at least two level)
  • ASA I-II-III patients

Exclusion criteria

  • Clinically known local anesthetic allergy
  • Morbid obesity (body mass index>40 kg m2)
  • Clinically diagnosis of opioid, alcohol and substance dependence
  • Clinically diagnosis of psychiatric disease
  • Coagulopathy
  • Patients with ASA IV-V
  • Single level surgery

Treatment and study plan

superficial erector spina plane block

Procedure

The investigators performed superficial erector spina plane block to that patient group for postoperative analgesia

Standard (opioid-based) analgesia

Procedure

The investigators performed intravenous opioid infusion with PCA to that patient group for postoperative analgesia

Primary outcomes

  1. NRS scores of patients

    Time frame: 48 hours postoperatively

    NRS at 1, 6,12, 18, 24, 36, 48th hours

Secondary outcomes

  1. Postoperative 48-hours total morphine consumption

    Time frame: 48 hours postoperatively

    This will be measured only one time by pca device at the 48th hour after surgery.

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

Intraoperative Placement of Superficial Erector Spinae Plane Block in Spine Surgery; An Effective Approach at Enhanced Recovery After Spine Surgery

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2022
Registry last updated
Mar 3, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.