Femur FractureNCT06813755
Pericapsular Nerve Group (PENG) Block on Pain During Participant Positioning for Spinal Anesthesia in Hip Fracture Surgery
An observational study of Femur Fracture and Hip Surgery, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Hip fracture surgery is a common orthopedic procedure, especially in elderly patients. These fractures are quite common in adults over the age of 65, and the one-year mortality rate ranges from 12% to 37%. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Femur Fracture, Hip Surgery
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2024to 26 May 2025
- Phase
- Observational
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 60 participants older than the age of 40 who will undergo hip fracture surgery under spinal anesthesia will be included in the study.
Who may be able to join
- hip fracture aged between 35 and 90 years old
Who cannot join
- contraindications for spinal anesthesia and PENG block impaired cognition or dementia multiple fractures any previous analgesic administration during the last 12 hours
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Training and Research Hospital
Istanbul
About this study
Official title: Effect of Ultrasound (USG)-Guided Pericapsular Nerve Group (PENG) Block on Pain During Participant Positioning for Spinal Anesthesia in Hip Fracture Surgery: a Randomized Controlled Trial
Hip fracture surgery is a common orthopedic procedure, especially in elderly patients. These fractures are quite common in adults over the age of 65, and the one-year mortality rate ranges from 12% to 37%. Recent studies have suggested that general anesthesia and spinal anesthesia are not superior to each other in patients undergoing hip fracture surgery. Untreated/poorly managed perioperative pain is directly linked to delirium, poor prognosis, and secondary chronic pain in hip fracture patients. Therefore, considering the associated mortality, morbidity, and early recovery, control of perioperative pain should be one of the highest priorities of the anesthesiologist, regardless of the anesthesia method used.
Read the detailed description
Ultrasonography (USG)-guided regional anesthesia techniques are often used as part of multimodal analgesia in the management of perioperative pain in patients with hip fractures. One of the most recently described blocks used in hip fracture surgery, the USG-guided pericapsular nerve group (PENG) block, aims to directly block the articular branch of the femoral nerve, the articular branch of the obturator nerve, and the accessory obturator nerve, which selectively innervates the anterior aspect of the hip capsule. Case reports and a limited number of clinical studies have reported that PENG block is effective in managing acute fracture-related pain, neuraxial anesthesia positioning pain, and postoperative pain in hip fracture patients.
In this study, investigators aimed to investigate the effect of USG-guided PENG block on positional pain before spinal anesthesia in patients undergoing surgery for hip fractures and to compare this effect with intravenous ketamine.
In addition, investigators aimed to investigate the effect of PENG block on pain scores, perioperative opioid consumption, time to first analgesic requirement in the postoperative period, and quality of recovery in the first 24 hours after surgery.
- Conditions
- Femur Fracture, Hip Surgery
- Keywords
- peng block, regional anesthesia, geriatric population
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Procedure: PENG Block Pericapsular Nerve Group Block | Active Comparator: PENG Block For patients with hip fracture and having hip surgery this study evaluates the analgesic effects of Pericapsular Nerve Group (PENG) block for positioning before spinal anesthesia. | |
| Drug: Conventional intravenous sedoanalgesia (ketamine) standardised intravenous sedoanalgesia agent | Active Comparator: Control in this group, standardised sedoanalgesia doses (drug: ketamine) will be used for analgesia for positioning pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores on the Numeric Rating Scale (NRS)
Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)
Secondary outcomes (3)
Duration of spinal anesthesia performance
It will be measured in "minutes", from the start of positioning maneuvers to the spinal needle removal
Measured: Group A: 5 minutes after intervention (intravenous ketamine), Group B: 20 minutes after intervention (PENG block)
Quality of patient's position
The position will be characterized as "unsatisfactory", "satisfactory", "good" or "very good"
Measured: Group A: 5 minutes after intervention (intravenous ketamine), Group B: 20 minutes after intervention (PENG block)
Analgesic consumption
In the postoperative period, patients will be given opioids according to their pain density with a rescue analgesia agent (tramadol).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start20 Nov 2024
- Primary completion20 May 2025
- Study completion26 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Femur FractureStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gul Cakmak, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813755
- Sponsor's protocol ID
- E-10840098-202.3.02-6997
- Status last verified
- May 2025
- First submitted
- 9 Dec 2024
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aygun H, Tulgar S, Yigit Y, Tasdemir A, Kurt C, Genc C, Bilgin S, Senoglu N, Koksal E. Effect of ultrasound-guided pericapsular nerve group (PENG) block on pain during patient positioning for central nervous blockade in hip surgery: a randomized controlled trial. BMC Anesthesiol. 2023 Sep 15;23(1):316. doi: 10.1186/s12871-023-02245-3.
PubMed 37715173
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound (USG)-Guided Pericapsular Nerve Group (PENG) Block on Pain During Participant Positioning for Spinal Anesthesia in Hip Fracture Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06813755
- Acronym / sponsor ID
- E-10840098-202.3.02-6997
- Conditions
- Femur Fracture, Hip Surgery
- Keywords
- peng block, regional anesthesia, geriatric population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 26 May 2025 (actual)
- First posted
- 7 Feb 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 fracture surgery is a common orthopedic procedure, especially in elderly patients. These fractures are quite common in adults over the age of 65, and the one-year mortality rate ranges from 12% to 37%. Recent studies have suggested that general anesthesia and spinal anesthesia are not superior to each other in patients undergoing hip fracture surgery. Untreated/poorly managed perioperative pain is directly linked to delirium, poor prognosis, and secondary chronic pain in hip fracture patients. Therefore, considering the associated mortality, morbidity, and early recovery, control of perioperative pain should be one of the highest priorities of the anesthesiologist, regardless of the anesthesia method used.
Detailed description
Ultrasonography (USG)-guided regional anesthesia techniques are often used as part of multimodal analgesia in the management of perioperative pain in patients with hip fractures. One of the most recently described blocks used in hip fracture surgery, the USG-guided pericapsular nerve group (PENG) block, aims to directly block the articular branch of the femoral nerve, the articular branch of the obturator nerve, and the accessory obturator nerve, which selectively innervates the anterior aspect of the hip capsule. Case reports and a limited number of clinical studies have reported that PENG block is effective in managing acute fracture-related pain, neuraxial anesthesia positioning pain, and postoperative pain in hip fracture patients.
In this study, investigators aimed to investigate the effect of USG-guided PENG block on positional pain before spinal anesthesia in patients undergoing surgery for hip fractures and to compare this effect with intravenous ketamine.
In addition, investigators aimed to investigate the effect of PENG block on pain scores, perioperative opioid consumption, time to first analgesic requirement in the postoperative period, and quality of recovery in the first 24 hours after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Procedure: PENG Block Pericapsular Nerve Group Block | – | –Active Comparator: PENG Block For patients with hip fracture and having hip surgery this study evaluates the analgesic effects of Pericapsular Nerve Group (PENG) block for positioning before spinal anesthesia. |
| Drug: Conventional intravenous sedoanalgesia (ketamine) standardised intravenous sedoanalgesia agent | – | –Active Comparator: Control in this group, standardised sedoanalgesia doses (drug: ketamine) will be used for analgesia for positioning pain |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 60 participants older than the age of 40 who will undergo hip fracture surgery under spinal anesthesia will be included in the study.
Key inclusion criteria (1 listed)
- hip fracture aged between 35 and 90 years old
Key exclusion criteria (1 listed)
- contraindications for spinal anesthesia and PENG block impaired cognition or dementia multiple fractures any previous analgesic administration during the last 12 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain scores on the Numeric Rating Scale (NRS)
Time frame: Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)
Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
3 secondary outcomes
Duration of spinal anesthesia performance
Time frame: Group A: 5 minutes after intervention (intravenous ketamine), Group B: 20 minutes after intervention (PENG block)
Quality of patient's position
Time frame: Group A: 5 minutes after intervention (intravenous ketamine), Group B: 20 minutes after intervention (PENG block)
Analgesic consumption
Time frame: 24 hours
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 29 May 2025.
- Background: PubMed 37715173Aygun H, Tulgar S, Yigit Y, Tasdemir A, Kurt C, Genc C, Bilgin S, Senoglu N, Koksal E. Effect of ultrasound-guided pericapsular nerve group (PENG) block on pain during patient positioning for central nervous blockade in hip surgery: a randomized controlled trial. BMC Anesthesiol. 2023 Sep 15;23(1):316. doi: 10.1186/s12871-023-02245-3.
- Individual participant dataSharing planned: Undecided
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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.
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?
An observational study of Femur Fracture and Hip Surgery, run by Marmara 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 1 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 29 May 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 scores on the Numeric Rating Scale (NRS) (time frame: Group A: 5 minutes after intervention (intravenous opioid), Group B: 20 minutes after intervention (PENG block)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06813755, which also lists 1 linked publication.
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 29 May 2025.