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Clinical Trials/NCT06728488
NCT06728488Active, not recruitingNot Applicable

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

Kocaeli University1 site in 1 country40 target enrollmentStarted: January 17, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
40
Locations
1
Primary Endpoint
vNRS Verbal Numerical Rating Scale

Study Overview

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.

Detailed Description

Patients with chronic hip pain will be divided into two groups, and after providing the necessary information, informed consent forms will be obtained for inclusion in the study from both groups. The 'Verbal Numerical Rating Scale (vNRS)' will be assessed before the procedure. Patients to undergo PENG block and PENG block with pulse radiofrequency ablation will be monitored prior to the procedure. After the procedure, they will be monitored for 3 hours under observation. At the third hour after the procedure, before leaving the operating room, and at the 1st and 3rd months, patients will be contacted by phone, and the 'Verbal Numerical Rating Scale (vNRS)' will be evaluated. This will allow the comparison of the effects of PENG block and PENG block with pulse radiofrequency ablation on pain management in chronic hip pain.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

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.

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •Patients with allergies to the medications used, severe cardiac, renal, pulmonary, liver, and endocrine diseases, patients with uncontrolled blood sugar levels (diabetes mellitus), patients who have used anticoagulant medications in the last five days, patients with bleeding or clotting disorders, those with implanted medical devices such as pacemakers and defibrillators, patients with infections at the procedure site, patients with psychiatric disorders or communication difficulties, patients with missing data, and patients who do not wish to undergo regional block are defined as exclusion criteria.

Arms & Interventions

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.

Intervention: PENG Block (Other)

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.

Intervention: PENG block and pulse radiofrequency ablation (Other)

Outcomes

Primary Outcomes

vNRS Verbal Numerical Rating Scale

Time Frame: 3 months

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Berkay BALCI

Research Assistant Doctor

Kocaeli University

Study Sites (1)

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