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Anesthesia for Percutaneous Kyphoplasty

NCT07091513 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-07-31

No results posted yet for this study

Summary

The aim of this study was to compare ESP with conventional local infiltration anesthesia (CLIA) and extrapedicular infiltration anesthesia (EPIA) with respect to analgesic efficacy in patients underwent elective PKP for VCF. A total of 90 ASA I-III patients were randomly assigned into three groups: group CLIA (n=30), group EPIA (n=30), and group ESP (n=30). The same amount of local anesthetic mixture (6 ml lidocaine 1% and 14 ml bupivacaine 0.5%) was used for regional anesthetic techniques in all groups. Fentanyl 0.1 mcg/kg and midazolam 0.1 mg/kg were intravenously (IV) given before prone positioning. Pain was evaluated using Visual Analogue Score (VAS) and sedation level using Ramsay Sedation Scale (RSS) during the procedure. Primary outcome measure were VAS and RSS scores. Secondary outcome measures were hemodynamic changes and additional analgesic and sedative consumptions

Conditions

  • Vertebral Compression Fracture
  • Kyphoplasty

Interventions

PROCEDURE

group ESP

. In the ESP group, a high frequency linear transducer (HFL50XP, SonoSite Inc., Bothell, WA, USA ) was located vertically approximately 3 cm lateral to the projection point with identification of the spinous process, lamina, transverse process, and the erector spinae muscle. The skin and subcutaneous tissues were infiltrated using 5 mL of 1% Lidocaine Hydrochloride. A 22-G peripheral nerve block needle (50 mm) (SonoTAP, Pajunk, Geisingen, Germany) was inserted in-plane from caudal to cranial between the fascia of the erector spinae muscle and the transverse process under the ultrasound guidance. After hydro-localization using 1 ml of with normal saline, this plane was opened. The same 20 mL mixture of LA was injected after negative aspiration of blood.

Sponsors & Collaborators

  • Gulhane School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-26
Primary Completion
2024-12-01
Completion
2025-03-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07091513 on ClinicalTrials.gov