Anesthesia for Percutaneous Kyphoplasty

NCT07091513 | Completed

• 1 other identifier: 2022/156
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Kyphoplasty; Vertebral compression fracture; Erector spinae plane block; Local anesthesia

Outcome Measures

Primary Outcomes (1)

• VAS scores

  A VAS value of 0 was defined to identify the absence of pain and 10 was defined as maximum pain.

  Briefly, after explanation of the use of VAS, patients were told that they would be asked to complete the scale at baseline (immediately before surgical preparation) and on the 15th, 20th, 30th and 45th minutes of the surgical procedure.

Study Arms (3)

group CLIA

ACTIVE COMPARATOR

In the CLIA group, the anesthetic needle was angled 10 to 15 degrees with the sagittal plane and was directed towards the laminar periosteum at the pedular projection point in the lamina and a mixture of 1% Lidocaine hydrochloride (6 mL) and 0.5% bupivacaine (14 mL) was injected.

Procedure: group ESP

Group EPİA

ACTIVE COMPARATOR

In the EPIA group, the anesthetic needle was directed towards the lateral half of the pedicle along the lateral superior articular process and the upper border of the transverse process (angulation 5 to 10 degrees with the sagittal plane and 5 to 10 degrees with the coronal plane), followed by the injection of the same 20 mL mixture

Procedure: group ESP

group ESP

ACTIVE COMPARATOR

. 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.

Procedure: group ESP

Interventions

group ESP PROCEDURE

. 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.

Group EPİA; group CLIA; group ESP

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status class I-III patients
• years old
• Elective, single- level thoracal or lumbar vertebrae kyphoplasty for VCF

You may not qualify if:

• patient refusal
• pregnancy,
• history of previous lumbar surgery,
• coagulation disorders,
• anticoagulation medication
• abnormal coagulation tests,
• allergy to the local anesthetics and study drugs,
• cognitive disorder,
• chronic pain therapy
• multiple-level vertebrae fractures

Sponsors & Collaborators

• Gulhane School of Medicine: lead

Study Sites (1)

Gülhane Medical Faculty

Ankara, KEÇiören, 06010, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 29, 2025
• Study Start: January 26, 2023
• Primary Completion: December 1, 2024
• Study Completion: March 31, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

TU (1)