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

Not Applicable

Completed

• Conditions: Spine Injury; Postoperative Pain; Spine Deformity; Spine Fracture; Spine Malformation

• Registration Number: NCT05244031
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-05-10
• Status Verified: 2022-02
• Primary Completion: 2022-02-07
• Study Completion: 2022-02-07
• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-02-08
• Last Update Submitted: 2022-02-16
• Study First Posted: 2022-02-17
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
NRS scores of patients	48 hours postoperatively	NRS at 1, 6,12, 18, 24, 36, 48th hours

Secondary Outcome Measures

Name	Time	Method
Postoperative 48-hours total morphine consumption	48 hours postoperatively	This will be measured only one time by pca device at the 48th hour after surgery.

Trial Locations

Locations (1)

Bakirkoy Dr. Sadi Konuk Research and Training Hospital; 🇹🇷 Istanbul, Bakirkoy, Turkey