Hip Fracture SurgeriesNCT07003633
Preoperative Analgesia: The Effectiveness of the PENG Block in Patients With Hip Fractures
A study testing PENG block with 0.25% bupivacaine guided by ultrasound. in people with Hip Fracture Surgeries, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
The aim is to provide effective preoperative analgesia in patients undergoing surgical procedures due to hip fractures by administering a pericapsular nerve group (PENG) block under ultrasound guidance. Read more about this study
- Who is it for?
- Ages 45 to 95 years
- Conditions the study is for
- Hip Fracture Surgeries
- What is being tested?
- PENG block with 0.25% bupivacaine guided by ultrasound.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 1 Jun 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 45 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing hip farcture surgery
Who cannot join
- Chronic analgesics consumption
- Patients contraindicated for neuraxial anesthesia
- Alcohol and drug addiction
- Allergies to local anesthetics and opioids
- Patients who refuses to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sakarya Universtiy Training and Research Hospital
Sakarya
Alim Miniksar, M.D., +905069499002, alimminiksar@gmail.com
About this study
Official title: Preoperative Analgesia: The Effect of the Pericapsular Nerve Group (PENG) Block Administered Preoperatively in Patients With Hip Fractures on Preoperative Analgesic Efficacy, Early Postoperative Discharge, Mortality, and Morbidity.
The aim is to provide effective preoperative analgesia in patients undergoing surgical procedures due to hip fractures by administering a pericapsular nerve group (PENG) block under ultrasound guidance. This approach seeks to increase patient satisfaction, reduce analgesic requirements, enable earlier discharge, and decrease morbidity and mortality.
- Conditions
- Hip Fracture Surgeries
- Being tested
- PENG block with 0.25% bupivacaine guided by ultrasound.
- Keywords
- Analgesia, PENG block, Hip Fracture
- Medical subject headings
- Agnosia, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG block with 0.25% bupivacaine guided by ultrasound.Procedure or surgery
PENG (Pericapsular nerve block) is a peripheral nerve block which is performed for patients with hip fractures aimed to prevent preoperative and postoperative pain. It is performed under sterile conditions under ultrasound guideance.
| Study group | Role | What they receive |
|---|---|---|
| Group PENG | Experimental | Group PENG will involve the patients who will be performed PENG block 24 hours before surgery. Receives: Procedure: PENG block with 0.25% bupivacaine guided by ultrasound. |
| Group Control | No intervention | Group Control will involve the patients who will not be performed PENG block preoperatively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Pain Scores and Opioid Consumption
Preoperative pain of patients will be assessed with NRS (Numeric Raitng Scale) which ranges from 0 (no pain) to 10 (the most severe pain imaginable).
Measured: 24 hours preoperatively
Secondary outcomes (3)
Discharge Time
Measured: From surgery to discharge up to 30 days
Postoperative Mortality and Morbidity
Postoperative complications such as infections, embolism, chronic pain and survival status
Measured: 30 days after surgery
Opioid Consumption
Opioid consumption will be assessed with patient controlled analgesia (PCA) device which measures analgesic drug consumption. Fentanyl consumption unit will be micrograms.
Measured: 24 hours preoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Fracture SurgeriesStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alim Miniksar, MD, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003633
- Sponsor's protocol ID
- E-43012747-050.04-463726-205
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Analgesia: The Effect of the Pericapsular Nerve Group (PENG) Block Administered Preoperatively in Patients With Hip Fractures on Preoperative Analgesic Efficacy, Early Postoperative Discharge, Mortality, and Morbidity.
- ClinicalTrials.gov ID
- NCT07003633
- Acronym / sponsor ID
- E-43012747-050.04-463726-205
- Conditions
- Hip Fracture Surgeries
- Keywords
- Analgesia, PENG block, Hip Fracture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 4 Jun 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.
The aim is to provide effective preoperative analgesia in patients undergoing surgical procedures due to hip fractures by administering a pericapsular nerve group (PENG) block under ultrasound guidance. This approach seeks to increase patient satisfaction, reduce analgesic requirements, enable earlier discharge, and decrease morbidity and mortality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group PENG | Experimental | Procedure: PENG block with 0.25% bupivacaine guided by ultrasound.Group PENG will involve the patients who will be performed PENG block 24 hours before surgery. |
| Group Control | No intervention | –Group Control will involve the patients who will not be performed PENG block preoperatively. |
Who may qualify
- Ages
- 45 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing hip farcture surgery
Key exclusion criteria (5 listed)
- Chronic analgesics consumption
- Patients contraindicated for neuraxial anesthesia
- Alcohol and drug addiction
- Allergies to local anesthetics and opioids
- Patients who refuses to participate in the study
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 |
|---|---|---|
| PENG block with 0.25% bupivacaine guided by ultrasound.PENG (Pericapsular nerve block) is a peripheral nerve block which is performed for patients with hip fractures aimed to prevent preoperative and postoperative pain. It is performed under sterile conditions under ultrasound guideance. | Procedure or surgery | Group PENG |
Primary outcome
Preoperative Pain Scores and Opioid Consumption
Time frame: 24 hours preoperatively
Preoperative pain of patients will be assessed with NRS (Numeric Raitng Scale) which ranges from 0 (no pain) to 10 (the most severe pain imaginable).
3 secondary outcomes
Discharge Time
Time frame: From surgery to discharge up to 30 days
Postoperative Mortality and Morbidity
Time frame: 30 days after surgery
Opioid Consumption
Time frame: 24 hours preoperatively
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 4 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
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Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PENG block with 0.25% bupivacaine guided by ultrasound. in people with Hip Fracture Surgeries, run by Sakarya 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 1 inclusion and 5 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: opening soon, as of the sponsor's last update on 4 Jun 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?
Contact Alim Miniksar, M.D. (+905069499002, alimminiksar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Pain Scores and Opioid Consumption (time frame: 24 hours preoperatively). 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 4 Jun 2025.