Comparison of the Analgesic Efficacy and Duration of Analgesic Effect of Pericapsular Nerve Group Block Block Application With PENG Block and Pulse Radiofrequency Ablation in Chronic Hip Pain

July 4, 2025 updated by: Berkay BALCI, Kocaeli University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Izmit
      • Kocaeli, Izmit, Turkey, 41000
        • Kocaeli University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PENG block
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
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.
Experimental: PENG block and pulse radiofrequency ablation
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kocaeli University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Scientific Research Projects Coordination Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 17, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AIBU-MED-BB-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Dietary Supplements

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