- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07255768
Comparison of the Efficacy of Pericapsular Nerve Group Block Alone Versus Pericapsular Nerve Group Block Combined With Superior Cluneal and Superior Gluteal Nerve Blocks in Patients Undergoing Hip Surgery
Comparison of the Efficacy of Pericapsular Nerve Group Block Alone Versus Pericapsular Nerve Group Block Combined With Superior Cluneal and Superior Gluteal Nerve Blocks in Patients Undergoing Hip Surgery: A Prospective Randomized Clinical Study
In the clinic, total hip arthroplasty is a frequently performed surgical procedure that often results in moderate to severe postoperative pain. Multimodal analgesia approaches are commonly preferred for managing this pain, and in recent years, nerve blocks targeting pelvic innervation have become increasingly prominent. Among these, the Pericapsular Nerve Group (PENG) block has gained attention for providing effective analgesia by targeting the nerves responsible for the anterior innervation of the hip capsule. However, when used alone, the PENG block may be insufficient for controlling posterior hip pain and may not provide complete analgesia.
In this context, adding blocks targeting the superior cluneal nerve and the superior gluteal nerve-both of which contribute to the sensory innervation of the posterior hip region-has been proposed to enhance the analgesic effect when combined with the PENG block. Superior cluneal and superior gluteal nerve blocks have recently been described in anatomical and clinical studies, and by affecting the structures contributing sensory input to the posterior hip capsule, they hold significant potential for improving pain management.
In this study, the investigators aimed to evaluate the contribution of superior cluneal and superior gluteal nerve blocks, when added to the PENG block, to perioperative analgesia in patients undergoing total hip arthroplasty. The investigators sought to comparatively investigate whether this combination offers superior outcomes compared with the PENG block alone. It was hypothesized that combined nerve blocks may provide similar or improved recovery scores, lower pain scores, reduced opioid consumption, and enhanced analgesic efficacy without affecting the degree of motor blockade.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Erzurum, Turkey (Türkiye)
- Ataturk University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Voluntary participation in the study
- Age between 18 and 80 years
- ASA physical status I, II, or III
- Male or female patients
Exclusion Criteria:
- Refusal to participate in the study
- Allergy to the medications to be used
- History of severe cardiac, renal, or hepatic disease
- Presence of neurological deficits or neuropathy
- History of anticoagulant use
- Previous surgery in the inguinal or suprainguinal region
- Pregnancy
- Chronic opioid use at home
- History of spinal surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Application of PENG Block
Patients will be brought to the operating room one hour before surgery, and no premedication will be administered prior to their arrival.
Before performing the PENG block, patients will be placed in the supine position.
The ultrasound probe will be positioned in the transverse plane medial and caudal to the anterior superior iliac spine, and the anterior inferior iliac spine, iliopubic eminence, and psoas tendon will be identified.
Using an in-plane technique, the needle will be advanced from lateral to medial and positioned between the psoas tendon and the periosteum.
After negative aspiration, 15 mL of 0.25% bupivacaine will be administered.
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For PENG Block, 15 mL of 0.25% bupivacaine will be administered.
After performing PENG; 10 mL of 0.25% bupivacaine will be administered for each superior cluneal nerve block and superior gluteal nerve block
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Active Comparator: Application of PENG Block together with Superior Cluneal and Superior Gluteal Nerve Blocks
All patients will receive a PENG block, and in addition: The superior cluneal nerve block will be performed at the level of the posterior iliac crest under ultrasound guidance, along the course of the nerve, using 10 mL of 0.25% bupivacaine. The superior gluteal nerve block will be administered in the lateral decubitus position under ultrasound guidance, with 10 mL of 0.25% bupivacaine injected between the gluteal muscles along the trajectory of the nerve. |
After performing PENG; 10 mL of 0.25% bupivacaine will be administered for each superior cluneal nerve block and superior gluteal nerve block
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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QoR-15 (Quality of Recovery-15) questionnaire
Time Frame: 24th and 48th postoperative hour
|
The primary outcome measure will be the QoR-15 (Quality of Recovery-15) questionnaire administered at the 24th postoperative hour.
QoR-15 is a validated 15-item short survey assessing patients' postoperative physical comfort, emotional state, level of independence, pain control, and overall well-being.
The total score obtained will be used to compare the overall quality of recovery between groups.
The same questionnaire will be repeated at the 48th postoperative hour.
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24th and 48th postoperative hour
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Quadriceps Motor Block Assessment
Time Frame: It will be assessed at the 4th, 8th, 12th, and 24th postoperative hours.
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Motor block will be assessed using the following 3-point scale: 0 = Normal strength (dorsiflexion against gravity and resistance)
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It will be assessed at the 4th, 8th, 12th, and 24th postoperative hours.
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Motor Block Assessment at the Tibialis Anterior Muscle for the Sciatic Nerve
Time Frame: It will be assessed at the 4th, 8th, 12th, and 24th postoperative hours.
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Motor block will be assessed using the following 3-point scale: 0 = Normal strength (dorsiflexion against gravity and resistance)
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It will be assessed at the 4th, 8th, 12th, and 24th postoperative hours.
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Fentanyl consumption
Time Frame: The first 24 postoperative hours
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Fentanyl consumption will be recorded via the PCA device during the postoperative intervals of 0-4, 4-8, and 8-24 hours.
Total opioid consumption will be calculated at the 24th postoperative hour.
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The first 24 postoperative hours
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VAS pain scores
Time Frame: The first 24 postoperative hours
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VAS pain scores will be assessed at the 1st, 2nd, 4th, 8th, 12th, and 24th postoperative hours, both at rest and during movement.
The region where the patient experiences the most intense pain will be recorded as either the anterior or posterior hip.
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The first 24 postoperative hours
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Bone Diseases
- Musculoskeletal Diseases
- Pathologic Processes
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Necrosis
- Osteoarthritis
- Osteonecrosis
- Pathological Conditions, Signs and Symptoms
- Osteoarthritis, Hip
- Legg-Calve-Perthes Disease
- Femur Head Necrosis
- Organic Chemicals
- Therapeutics
- Drug Administration Routes
- Drug Therapy
- Anilides
- Amides
- Aniline Compounds
- Amines
- Bupivacaine
- Injections
Other Study ID Numbers
- PENGHip
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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