Hip Fractures (ICD-10 72.01-72.2)PENG-SPINENCT07194356
Effect of Preoperative PENG Block on Spinal Anesthesia Positioning and Postoperative Analgesia in Hip Fracture Surgery
A study testing Pericapsular nerve group (PENG) block in people with Hip Fractures (ICD-10 72.01-72.2) and Postoperative Pain Management After Total Hip Arthroplasty, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Hip fractures are among the most common orthopedic traumas, particularly in elderly patients, and are usually associated with significant pain during positioning for spinal anesthesia. Adequate pain control during positioning can improve patient comfort and facilitate successful administration of anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hip Fractures (ICD-10 72.01-72.2), Postoperative Pain Management After Total Hip Arthroplasty, Elderly Patients
- What is being tested?
- Pericapsular nerve group (PENG) block
- Type of treatment
- Pill or oral medicine, Injection or infusion, 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 Dec 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 90 years
- ASA (American Society of Anesthesiologists) physical status classification I-III
- Scheduled for proximal femoral nailing due to hip fracture
- Able to provide informed consent (or consent provided by a legal representative)
- Willingness to comply with study procedures and follow-up assessments
Who cannot join
- - ASA physical status classification IV or V
- Refusal to provide informed consent
- Coagulopathy or current use of anticoagulant therapy contraindicating neuraxial block
- Local infection at the injection site
- Known allergy or hypersensitivity to local anesthetic agents
- Cognitive impairment or inability to cooperate with study procedures
Show all 9Show fewer
- Severe psychiatric illness preventing reliable pain assessment
- Previous surgery or deformity of the hip interfering with block performance
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Facility Name: Kartal Dr. Lütfi Kırdar City Hospital, University of Health Sciences
Istanbul, 34890
About this study
Official title: A Randomized Controlled Trial Evaluating the Effect of Preoperative Pericapsular Nerve Group (PENG) Block on Positioning for Spinal Anesthesia and Postoperative Analgesia in Patients Undergoing Hip Fracture Surgery
Hip fractures are among the most common orthopedic traumas, particularly in elderly patients, and are usually associated with significant pain during positioning for spinal anesthesia. Adequate pain control during positioning can improve patient comfort and facilitate successful administration of anesthesia. The pericapsular nerve group (PENG) block has recently been introduced as a regional anesthesia technique that targets articular branches of the femoral, obturator, and accessory obturator nerves, and has been proposed as a method to reduce pain related to hip fracture positioning.
This study is designed to compare the efficacy of preoperative PENG block versus no block in patients undergoing proximal femoral nailing surgery under spinal anesthesia. The primary objective is to assess its effect on positioning pain using visual analog scale (VAS) scores. Secondary objectives include evaluating its impact on postoperative analgesic consumption, time to first rescue analgesic, and potential side effects.
Read the detailed description
This is a prospective, single-center, randomized controlled trial conducted at the University of Health Sciences, Kartal Dr. Lütfi Kırdar City Hospital. A total of 60 patients, aged 18-90 years, with ASA I-III status, scheduled for proximal femoral nailing (PFN) surgery due to hip fracture, were enrolled. Patients were randomized into two groups using a sealed-envelope method:
PENG Block Group: Received a preoperative ultrasound-guided pericapsular nerve group (PENG) block 30 minutes before spinal anesthesia.
Control Group: Received no block prior to spinal anesthesia.
Standard spinal anesthesia was performed in both groups. All patients received intravenous paracetamol for postoperative analgesia at regular intervals. Additional analgesia with intravenous tramadol was administered if VAS ≥ 4.
The following parameters were collected:
Demographics (age, sex, BMI, ASA status, comorbidities)
Hemodynamic variables (SBP, DBP, HR, SpO₂) at baseline and during perioperative period
VAS scores at baseline, during positioning, and at postoperative time intervals (0, 15, 30 minutes, and 1, 2, 6, 12, and 24 hours)
Time to first rescue analgesic
Total opioid consumption in the first 24 hours postoperatively
Side effects such as nausea, vomiting, or other complications
The study aims to test the hypothesis that PENG block can reduce pain during positioning for spinal anesthesia and may improve postoperative analgesia in patients undergoing hip fracture surgery.
- Conditions
- Hip Fractures (ICD-10 72.01-72.2), Postoperative Pain Management After Total Hip Arthroplasty, Elderly Patients, Regional Anesthesia
- Being tested
- Pericapsular nerve group (PENG) block, Standard Spinal Anesthesia (Control)
- Keywords
- PENG Block, Pericapsular Nerve Group Block, Hip Surgery, Geriatric Anesthesia, Analgesia, Visual Analog Scale, Tramadol, Ultrasound-Guided Block, Positioning Pain, Peripheral Nerve Block
- Medical subject headings
- Hip Fractures, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular nerve group (PENG) blockProcedure or surgery
A single-shot PENG block was administered preoperatively using ultrasound guidance. The block was performed with the patient in the supine position, and 20 mL of local anesthetic (0.25% bupivacaine) was injected between the psoas tendon and the superior pubic ramus to achieve analgesia of the anterior hip capsule.
Standard Spinal Anesthesia (Control)Procedure or surgery
Patients in this arm were managed according to standard care protocols for spinal anesthesia in hip fracture surgery. No preoperative regional block was performed. Pain scores and postoperative tramadol use were measured for comparison with the experimental arm.
| Study group | Role | What they receive |
|---|---|---|
| PENG Block Group | Experimental | Patients in this group received an ultrasound-guided Pericapsular Nerve Group (PENG) block prior to spinal anesthesia for hip fracture surgery. The block was performed with local anesthetic injection under ultrasound guidance, targeting the articular branches innervating the anterior hip capsule. Receives: Procedure: Pericapsular nerve group (PENG) block |
| Control Group | Active comparator | Patients in this group did not receive a preoperative nerve block. They underwent spinal anesthesia directly for hip fracture surgery without prior intervention. Pain during positioning and postoperative analgesic requirements were evaluated in comparison to the PENG block group. Receives: Procedure: Standard Spinal Anesthesia (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity during positioning for spinal anesthesia
Pain scores were recorded using the Visual Analog Scale (VAS; 0-10 cm, where 0 = no pain and 10 = worst pain imaginable) during positioning for spinal anesthesia prior to hip fracture surgery.
Measured: During spinal anesthesia positioning (within 15 minutes preoperatively)
Secondary outcomes (4)
Postoperative VAS scores
Pain scores were assessed using the Visual Analog Scale (VAS) at 2, 6, 12, and 24 hours postoperatively.
Measured: 0-24 hours after surgery
Cumulative tramadol requirement in the first 24 hours
The total dose of intravenous tramadol administered for breakthrough pain was recorded for each patient.
Measured: 0-24 hours after surgery
Time to first request for rescue analgesia
The duration (in hours) between the end of surgery and the first administration of rescue tramadol was recorded.
Measured: 0-24 hours after surgery
Incidence of adverse events related to anesthesia
Frequency of side effects such as nausea, vomiting, hypotension, and local anesthetic systemic toxicity were documented.
Measured: Intraoperative to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start1 Dec 2023
- Primary completion31 Mar 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Fractures (ICD-10 72.01-72.2)Studies 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
- Model description
- A randomized, parallel-group, controlled trial evaluating the effectiveness of PENG block versus no block in patients undergoing hip fracture surgery under spinal anesthesia.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gülcan GÜL, Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Investigators
- Gulcan Gul, M.D., Principal investigator, Department of Anesthesiology and Reanimation, Kartal Dr. Lütfi Kırdar City Hospital, University of Health Sciences, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194356
- Sponsor's protocol ID
- KLKSH-ANES-PENG-001
- Other IDs
- 2023/514/261/14
- Acronym
- PENG-SPINE
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan Description: Individual participant data (IPD) will not be shared because this study was a single-center thesis project with a limited sample size. Only summary-level results and aggregate data will be published in peer-reviewed journals. Patient confidentiality and institutional data protection policies prevent public release of individual-level datasets.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating the Effect of Preoperative Pericapsular Nerve Group (PENG) Block on Positioning for Spinal Anesthesia and Postoperative Analgesia in Patients Undergoing Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT07194356
- Acronym / sponsor ID
- PENG-SPINE / KLKSH-ANES-PENG-001
- Conditions
- Hip Fractures (ICD-10 72.01-72.2), Postoperative Pain Management After Total Hip Arthroplasty, Elderly Patients, Regional Anesthesia
- Keywords
- PENG Block, Pericapsular Nerve Group Block, Hip Surgery, Geriatric Anesthesia, Analgesia, Visual Analog Scale, Tramadol, Ultrasound-Guided Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 26 Sep 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.
Hip fractures are among the most common orthopedic traumas, particularly in elderly patients, and are usually associated with significant pain during positioning for spinal anesthesia. Adequate pain control during positioning can improve patient comfort and facilitate successful administration of anesthesia. The pericapsular nerve group (PENG) block has recently been introduced as a regional anesthesia technique that targets articular branches of the femoral, obturator, and accessory obturator nerves, and has been proposed as a method to reduce pain related to hip fracture positioning.
This study is designed to compare the efficacy of preoperative PENG block versus no block in patients undergoing proximal femoral nailing surgery under spinal anesthesia. The primary objective is to assess its effect on positioning pain using visual analog scale (VAS) scores. Secondary objectives include evaluating its impact on postoperative analgesic consumption, time to first rescue analgesic, and potential side effects.
Detailed description
This is a prospective, single-center, randomized controlled trial conducted at the University of Health Sciences, Kartal Dr. Lütfi Kırdar City Hospital. A total of 60 patients, aged 18-90 years, with ASA I-III status, scheduled for proximal femoral nailing (PFN) surgery due to hip fracture, were enrolled. Patients were randomized into two groups using a sealed-envelope method:
PENG Block Group: Received a preoperative ultrasound-guided pericapsular nerve group (PENG) block 30 minutes before spinal anesthesia.
Control Group: Received no block prior to spinal anesthesia.
Standard spinal anesthesia was performed in both groups. All patients received intravenous paracetamol for postoperative analgesia at regular intervals. Additional analgesia with intravenous tramadol was administered if VAS ≥ 4.
The following parameters were collected:
Demographics (age, sex, BMI, ASA status, comorbidities)
Hemodynamic variables (SBP, DBP, HR, SpO₂) at baseline and during perioperative period
VAS scores at baseline, during positioning, and at postoperative time intervals (0, 15, 30 minutes, and 1, 2, 6, 12, and 24 hours)
Time to first rescue analgesic
Total opioid consumption in the first 24 hours postoperatively
Side effects such as nausea, vomiting, or other complications
The study aims to test the hypothesis that PENG block can reduce pain during positioning for spinal anesthesia and may improve postoperative analgesia in patients undergoing hip fracture surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, parallel-group, controlled trial evaluating the effectiveness of PENG block versus no block in patients undergoing hip fracture surgery under spinal anesthesia.
| Arm | Type | Receives |
|---|---|---|
| PENG Block Group | Experimental | Procedure: Pericapsular nerve group (PENG) blockPatients in this group received an ultrasound-guided Pericapsular Nerve Group (PENG) block prior to spinal anesthesia for hip fracture surgery. The block was performed with local anesthetic injection under ultrasound guidance, targeting the articular branches innervating the anterior hip capsule. |
| Control Group | Active comparator | Procedure: Standard Spinal Anesthesia (Control)Patients in this group did not receive a preoperative nerve block. They underwent spinal anesthesia directly for hip fracture surgery without prior intervention. Pain during positioning and postoperative analgesic requirements were evaluated in comparison to the PENG block group. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 to 90 years
Key exclusion criteria (9 listed)
- - ASA physical status classification IV or V
- Refusal to provide informed consent
- Coagulopathy or current use of anticoagulant therapy contraindicating neuraxial block
- Local infection at the injection site
- Known allergy or hypersensitivity to local anesthetic agents
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 |
|---|---|---|
| Pericapsular nerve group (PENG) blockA single-shot PENG block was administered preoperatively using ultrasound guidance. The block was performed with the patient in the supine position, and 20 mL of local anesthetic (0.25% bupivacaine) was injected between the psoas tendon and the superior pubic ramus to achieve analgesia of the anterior hip capsule. | Procedure or surgery | PENG Block Group |
| Standard Spinal Anesthesia (Control)Patients in this arm were managed according to standard care protocols for spinal anesthesia in hip fracture surgery. No preoperative regional block was performed. Pain scores and postoperative tramadol use were measured for comparison with the experimental arm. | Procedure or surgery | Control Group |
Primary outcome
Pain intensity during positioning for spinal anesthesia
Time frame: During spinal anesthesia positioning (within 15 minutes preoperatively)
Pain scores were recorded using the Visual Analog Scale (VAS; 0-10 cm, where 0 = no pain and 10 = worst pain imaginable) during positioning for spinal anesthesia prior to hip fracture surgery.
4 secondary outcomes
Postoperative VAS scores
Time frame: 0-24 hours after surgery
Cumulative tramadol requirement in the first 24 hours
Time frame: 0-24 hours after surgery
Time to first request for rescue analgesia
Time frame: 0-24 hours after surgery
Incidence of adverse events related to anesthesia
Time frame: Intraoperative to 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No. Plan Description: Individual participant data (IPD) will not be shared because this study was a single-center thesis project with a limited sample size. Only summary-level results and aggregate data will be published in peer-reviewed journals. Patient confidentiality and institutional data protection policies prevent public release of individual-level datasets.
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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. This study is not recruiting at the moment.
Gulcan Gul, M.D. principal investigator
Department of Anesthesiology and Reanimation, Kartal Dr. Lütfi Kırdar City Hospital, University of Health Sciences, Istanbul, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pericapsular nerve group (PENG) block in people with Hip Fractures (ICD-10 72.01-72.2) and Postoperative Pain Management After Total Hip Arthroplasty, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital 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 5 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: finished, as of the sponsor's last update on 26 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain intensity during positioning for spinal anesthesia (time frame: During spinal anesthesia positioning (within 15 minutes 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 26 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.