Hip OsteoarthritisNCT07255768
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 study testing 15 ml Bupivacaine Hcl 0.25% injection and 20 mL bupivacaine 0.25% injection in people with Hip Osteoarthritis and Osteonecrosis of the Femoral Head, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hip Osteoarthritis, Osteonecrosis of the Femoral Head, Avascular Necrosis of Femur Head
- What is being tested?
- 15 ml Bupivacaine Hcl 0.25% injection and 20 mL bupivacaine 0.25% injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation in the study
- Age between 18 and 80 years
- ASA physical status I, II, or III
- Male or female patients
Who cannot join
- 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
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- Pregnancy
- Chronic opioid use at home
- History of spinal surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Hip Osteoarthritis, Osteonecrosis of the Femoral Head, Avascular Necrosis of Femur Head, Dysplasia of Hip Joint, Hip Surgeries
- Being tested
- 15 ml Bupivacaine Hcl 0.25% injection, 20 mL bupivacaine 0.25% injection
- Medical subject headings
- Osteoarthritis, Hip, Legg-Calve-Perthes Disease, Femur Head Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15 ml Bupivacaine Hcl 0.25% injectionDrug
For PENG Block, 15 mL of 0.25% bupivacaine will be administered.
20 mL bupivacaine 0.25% injectionDrug
After performing PENG; 10 mL of 0.25% bupivacaine will be administered for each superior cluneal nerve block and superior gluteal nerve block
| Study group | Role | What they receive |
|---|---|---|
| Application of PENG Block | Active comparator | 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. Receives: Drug: 15 ml Bupivacaine Hcl 0.25% injection; Drug: 20 mL bupivacaine 0.25% injection |
| Application of PENG Block together with Superior Cluneal and Superior Gluteal Nerve Blocks | Active comparator | 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. Receives: Drug: 20 mL bupivacaine 0.25% injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
QoR-15 (Quality of Recovery-15) questionnaire
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.
Measured: 24th and 48th postoperative hour
Secondary outcomes (4)
Quadriceps Motor Block Assessment
Motor block will be assessed using the following 3-point scale:
0 = Normal strength (dorsiflexion against gravity and resistance)
- = Paresis (dorsiflexion against gravity only, not against resistance)
- = Paralysis (dorsiflexion not possible)
Measured: It will be assessed at the 4th, 8th, 12th, and 24th postoperative hours.
Motor Block Assessment at the Tibialis Anterior Muscle for the Sciatic Nerve
Motor block will be assessed using the following 3-point scale:
0 = Normal strength (dorsiflexion against gravity and resistance)
- = Paresis (dorsiflexion against gravity only, not against resistance)
- = Paralysis (dorsiflexion not possible)
Measured: It will be assessed at the 4th, 8th, 12th, and 24th postoperative hours.
Fentanyl consumption
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.
Measured: The first 24 postoperative hours
VAS pain scores
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.
Measured: The first 24 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start1 Sep 2025
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Murat Yayik, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255768
- Sponsor's protocol ID
- PENGHip
- Status last verified
- Dec 2025
- First submitted
- 16 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07255768
- Acronym / sponsor ID
- PENGHip
- Conditions
- Hip Osteoarthritis, Osteonecrosis of the Femoral Head, Avascular Necrosis of Femur Head, Dysplasia of Hip Joint, Hip Surgeries
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 1 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Application of PENG Block | Active comparator | Drug: 15 ml Bupivacaine Hcl 0.25% injection, Drug: 20 mL bupivacaine 0.25% injectionPatients 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. |
| Application of PENG Block together with Superior Cluneal and Superior Gluteal Nerve Blocks | Active comparator | Drug: 20 mL bupivacaine 0.25% injectionAll 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntary participation in the study
- Age between 18 and 80 years
- ASA physical status I, II, or III
- Male or female patients
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 15 ml Bupivacaine Hcl 0.25% injectionFor PENG Block, 15 mL of 0.25% bupivacaine will be administered. | Drug | Application of PENG Block |
| 20 mL bupivacaine 0.25% injectionAfter performing PENG; 10 mL of 0.25% bupivacaine will be administered for each superior cluneal nerve block and superior gluteal nerve block | Drug | Application of PENG Block, Application of PENG Block together with Superior Cluneal and Superior Gluteal Nerve Blocks |
Primary outcome
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.
4 secondary outcomes
Quadriceps Motor Block Assessment
Time frame: It will be assessed at the 4th, 8th, 12th, and 24th postoperative hours.
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.
Fentanyl consumption
Time frame: The first 24 postoperative hours
VAS pain scores
Time frame: The first 24 postoperative hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 15 ml Bupivacaine Hcl 0.25% injection and 20 mL bupivacaine 0.25% injection in people with Hip Osteoarthritis and Osteonecrosis of the Femoral Head, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QoR-15 (Quality of Recovery-15) questionnaire (time frame: 24th and 48th postoperative hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.