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Clinical Trials/NCT06567964
NCT06567964
Completed
Not Applicable

Comparative Efficacy of Ultrasound-guided Erector Spinae Plane Block Versus Wound Infiltration for Postoperative Analgesia in Instrumented Lumbar Spinal Surgeries

Saglik Bilimleri Universitesi1 site in 1 country80 target enrollmentMay 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lumbar Spinal Stenosis
Sponsor
Saglik Bilimleri Universitesi
Enrollment
80
Locations
1
Primary Endpoint
Postoperative pain intensity
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study aimed to compare the efficacy of ultrasound-guided erector spinae plane block (ESPB) with that of wound infiltration (WI) for postoperative analgesia in lumbar spinal surgeries involving instrumentation.

Detailed Description

In this randomized controlled trial, 80 patients were divided into two groups: ESPB (n=40) and WI (n=40). Postoperative pain intensity was assessed using the Visual Analog Scale (VAS) at multiple time points within 24 hours. Additionally, opioid consumption, time to first rescue analgesia, incidence of postoperative nausea and vomiting (PONV), and patient satisfaction were evaluated.

Registry
clinicaltrials.gov
Start Date
May 1, 2023
End Date
June 30, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

YÜCEL YÜCE

Associate Professor

Saglik Bilimleri Universitesi

Eligibility Criteria

Inclusion Criteria

  • Elective lumbar spine surgery involving instrumentation
  • ASA physical status I-III
  • Ability to provide informed consent

Exclusion Criteria

  • Known allergies to local anesthetics
  • Coagulopathy or anticoagulant therapy
  • Infection at the injection site
  • Preexisting neurological disorders affecting sensory perception
  • Pregnancy
  • Inability to understand the visual analog scale (VAS) for pain assessment

Outcomes

Primary Outcomes

Postoperative pain intensity

Time Frame: 1., 6., 12., 24., and 48. hours postoperatively

The pain intensity was assessed via the visual analog scale (VAS).The VAS is a 10 cm scale ranging from 0 (no pain) to 10 (worst imaginable pain).

Secondary Outcomes

  • Time to first request for rescue analgesia(Noted in hours in the first 48 hours postoperatively)
  • Total Opioid Consumption(In the first 48 hours postoperatively)
  • Incidence of Side Effects(Recorded as binary outcomes (present/absent) in the first 48 hours postoperatively)
  • Patient Satisfaction with Pain Management(At 48 hours postoperatively)

Study Sites (1)

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