NCT06728488

Brief Summary

Comparison of the analgesic efficacy and duration of analgesic effect of PENG block application with PENG block and pulse radiofrequency ablation in chronic hip pain.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 11, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

January 17, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

10 months

First QC Date

December 6, 2024

Last Update Submit

July 4, 2025

Conditions

Keywords

hip pain chronicRadiofrequency ablationPENG blockvNRS (Verbal Numerical Rating Scale)

Outcome Measures

Primary Outcomes (1)

  • vNRS Verbal Numerical Rating Scale

    Verbal Numerical Rating Scale.At the 3rd hour after the procedure, before the patients leave the operating room, and at the 1st and 3rd months, they will be contacted by phone, and the 'Verbal Numerical Rating Scale (vNRS)' will be evaluated.

    3 months

Study Arms (2)

PENG block

EXPERIMENTAL

The patients in the PENG block group will provide their consent. Standard monitoring will be applied. The patients will be positioned supine. After antiseptic procedures, 2 ml of 2% lidocaine will be infiltrated into the needle insertion site. The linear ultrasound probe will be placed in the transverse plane over the AIIS. The position of the ultrasound probe will be verified by visualizing the iliopectineal eminence, iliopsoas muscle and tendon, femoral artery, and pectineus muscle. Using a Stimuplex® A 100 mm 20 gauge needle (Braun Melsungen AG, Melsungen, Germany) with the in-plane technique, the needle will be inserted laterally to medially into the space between the psoas tendon and the pubic ramus. Negative aspiration will be performed to ensure no blood is aspirated, and then 20 ml of 0.25% bupivacaine and 8 mg of dexamethasone will be injected to perform the PENG block. After the procedure, the cannula will be removed, and the insertion site will be cleaned and dressed.

Other: PENG Block

PENG block and pulse radiofrequency ablation

EXPERIMENTAL

After obtaining consent, the patients in the PENG block and pulse radiofrequency ablation group will be brought into the operating room. Standard monitoring will be applied (ECG, SpO2, NIBP). The patients will be positioned supine. After performing the necessary aseptic and antiseptic procedures, 2 ml of 2% lidocaine will be infiltrated into the needle insertion site. The Boston Scientific unified echogenic 10cmx10mmx20G (0.9mm) radiofrequency cannula will be advanced until it makes contact with the superior ramus near the iliopectineal eminence. Pulse radiofrequency ablation will be performed with two cycles of 90 seconds each, and after each cycle, the needle will be moved 2 mm medially. After pulse radiofrequency ablation, 20 ml of 0.25% bupivacaine and 8 mg of dexamethasone will be applied. After the procedure, the cannula will be removed, and the insertion site will be cleaned and dressed.

Other: PENG block and pulse radiofrequency ablation

Interventions

The patients in the PENG block group will provide their consent. Standard monitoring will be applied. The patients will be positioned supine. After antiseptic procedures, 2 ml of 2% lidocaine will be infiltrated into the needle insertion site. The linear ultrasound probe will be placed in the transverse plane over the AIIS. The position of the ultrasound probe will be verified by visualizing the iliopectineal eminence, iliopsoas muscle and tendon, femoral artery, and pectineus muscle. Using a Stimuplex® A 100 mm 20 gauge needle (Braun Melsungen AG, Melsungen, Germany) with the in-plane technique, the needle will be inserted laterally to medially into the space between the psoas tendon and the pubic ramus. Negative aspiration will be performed to ensure no blood is aspirated, and then 20 ml of 0.25% bupivacaine and 8 mg of dexamethasone will be injected to perform the PENG block. After the procedure, the cannula will be removed, and the insertion site will be cleaned and dressed.

PENG block

After obtaining consent, the patients in the PENG block and pulse radiofrequency ablation group will be brought into the operating room. Standard monitoring will be applied (ECG, SpO2, NIBP). The patients will be positioned supine. After performing the necessary aseptic and antiseptic procedures, 2 ml of 2% lidocaine will be infiltrated into the needle insertion site. The Boston Scientific unified echogenic 10cmx10mmx20G (0.9mm) radiofrequency cannula will be advanced until it makes contact with the superior ramus near the iliopectineal eminence. Pulse radiofrequency ablation will be performed with two cycles of 90 seconds each, and after each cycle, the needle will be moved 2 mm medially. After pulse radiofrequency ablation, 20 ml of 0.25% bupivacaine and 8 mg of dexamethasone will be applied. After the procedure, the cannula will be removed, and the insertion site will be cleaned and dressed.

PENG block and pulse radiofrequency ablation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic hip pain Aged 18-80 ASA I-III patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, IZMIT, 41000, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Both surgical groups will be randomly assigned into groups using simple randomization through the -www.randomize.net- application, and a single-blind design will be implemented.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparison of the analgesic efficacy and duration of analgesic effect of PENG block application with PENG block and pulse radiofrequency ablation in chronic hip pain.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Doctor

Study Record Dates

First Submitted

December 6, 2024

First Posted

December 11, 2024

Study Start

January 17, 2025

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

July 9, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Locations