Regional AnesthesiaNCT07061223
SFIB vs PENG Block in the Anesthesia for Total Hip Replacement
A study testing SFIB, PENG block and General inhalation anaesthesia in people with Regional Anesthesia and Hip Arthroplasty, run by State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia at 1 site in Russia.
Trial summary
Total hip replacement is one of the most common orthopedic operations. According to statistical studies, more than 1 million of such surgical interventions are performed annually in the world. The average age of primary hip replacement surgery is 69 y.o. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Regional Anesthesia, Hip Arthroplasty
- What is being tested?
- SFIB, PENG block and General inhalation anaesthesia
- 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
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jul 2025to 20 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed, dated informed consent form
- Age from 50 to 75 years
- Indications for primary total hip replacement
- American Society of Anesthesiologists (ASA) score from 1 to 3
Who cannot join
- Patients receiving beta blockers;
- Infectious manifestations at the puncture site;
- Bleeding, clinically significant hypovolemia of any origin, shock;
- Disorders of the blood coagulation system;
- Intolerance to local anesthetics;
- Demyelinating diseases of the nervous system;
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- Allergy to local anesthetics;
- Psychiatric diseases;
- Any conditions that prevent obtaining informed consent.
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: Comparative Analysis of the Effectiveness and Safety of Suprainguinal Fascia Iliaca Block (SFIB) and Pericapsular Nerve Group (PENG) Block in the Anesthesia Complex for Total Hip Replacement
Total hip replacement is one of the most common orthopedic operations. According to statistical studies, more than 1 million of such surgical interventions are performed annually in the world. The average age of primary hip replacement surgery is 69 y.o.
Modern approaches of control of general anesthesia allow safe performance of different surgical interventions under general anesthesia. However, general anesthesia does not have an effective and long-lasting effect on relieving operational stress compared to neuraxial anesthesia. To achieve a similar effect, it is necessary to adhere to the principle of multimodality of anesthesia, and the most promising method is a combination of general and regional anesthesia. peripheral blocks are described in the literature, aimed at analgesia directly in the hip joint area, and effectively used in orthopedics.
Read more
Most blocks are currently performed under ultrasound control, the risk of nerve damage and accidental intravascular administration of local anesthetics is potentially reduced. It was established that the use of ultrasound guidance reduces the number of attempts and the amount of anesthetic administered, as well as reduces the time required to perform a block.
Another predicted effect is a reduction in the doses of opioids and non-steroidal anti-inflammatory drugs (NSAIDs), which can cause gastrointestinal bleeding and have a nephrotoxic effect, and can also depress breathing. It should be noted that patients over 65 y.o., have the highest risks of these side effects.
This study aims to compare the effectiveness and safety of SFIB and PENG block in hip replacement, as well as evaluation of the effectiveness of combined anesthesia in comparison with general anesthesia without the use of peripheral blocks.
Read the detailed description
Patients will be randomized into three groups group:
Group 1: General anesthesia with SFIB
In this group, under the ultrasound control, a local anesthetic will be injected into the interfacial space of the iliac muscle, in the area of the passage of the deep artery that surrounds the ilium. The block will be performed over the inguinal fold medial to the upper anterior iliac spine. After ultrasound identification of the needle's location in the interfacial space, 40 ml of a 0.5% solution of Ropivacaine will be administered.
Group 2: General anesthesia with PENG block
The block is performed using ultrasound navigation. After identifying the ileo-lumbar tendon, 40 ml of 0.5% Ropivacaine solution is injected under it. Ropivacaine spreads through the hip joint capsule and blocks small sensitive branches of the femoral and obturator nerves.
Group 3: Control group with general inhalation anesthesia
The control group will undergo general inhalation anesthesia with bolus intraoperative administration of Fentanyl before particularly traumatic stages. For postoperative pain relief, the patient will have the opportunity to use a fentanyl bolus according to the patient-controled analgesia protocol.
The following parameters will be evaluated
- Hemodynamic parameters in the intraoperative period
- Intraoperative monitoring of basal metabolic rate using indirect calorimetry
- Monitoring of glucose levels during the most traumatic stages of surgery
- Recording the total dose of opioid analgesics in the perioperative period
- Degree of postoperative pain and analgesic therapy administered
- Block execution time
- Complications of conducting anesthesia
- Degree of patient satisfaction with anesthesia
- Conditions
- Regional Anesthesia, Hip Arthroplasty
- Being tested
- SFIB, PENG block, Patient control analgesia, General inhalation anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SFIBProcedure or surgery
The block technique is based on administration of a local anesthetic under the iliac fascia to block the femoral, lateral femoral cutaneous, and obturator nerves. It is assumed that further leakage of local anesthetic through the interfascial space leads to blocking of the branches of the lumbar plexus in the small pelvis.
PENG blockProcedure or surgery
The hip capsule is the main source of pain because the innervation of the joint capsule is a developed network of articular branches of the femoral, sciatic and obturator nerves. The main idea of this technique is to block these branches at the point of common passage between the tendon of the lumbar muscle and the crest of the pubic bone. The block technique is based on administration of a local anesthetic under the ileo-lumbar tendon. Anesthetic spreads through the hip joint capsule and blocks small sensitive branches of the femoral and obturator nerves.
Patient control analgesiaProcedure or surgery
In the postoperative period, if pain occurs, the patient will be offered the opportunity to use 20 ug Fentanyl solution bolus according to the patient control analgesia (PCA) without a basic infusion.
General inhalation anaesthesiaProcedure or surgery
General inhalation anesthesia will be performed in all groups, Desflurane with a minimal alveolar concentration (MAC) of 0.6-0.8 will be used for maintenance
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia with SFIB | Experimental | In this group, under the ultrasound control, a local anesthetic will be injected into the interfacial space of the iliac muscle, in the area of the passage of the deep artery that surrounds the ilium. The block will be performed over the inguinal fold medial to the upper anterior iliac spine. After ultrasound identification of the needle's location in the interfacial space, 40 ml of a 0.5% solution of Ropivacaine will be administered. Receives: Procedure: SFIB; Procedure: Patient control analgesia; Procedure: General inhalation anaesthesia |
| General anesthesia with PENG block | Experimental | The block is performed using ultrasound navigation. After identifying the ileo-lumbar tendon, 40 ml of 0.5% Ropivacaine solution is injected under it. Ropivacaine spreads through the hip joint capsule and blocks small sensitive branches of the femoral and obturator nerves. Receives: Procedure: PENG block; Procedure: Patient control analgesia; Procedure: General inhalation anaesthesia |
| Control group with general inhalation anesthesia | Other | The control group will undergo general inhalation anesthesia with bolus intraoperative administration of Fentanyl before particularly traumatic stages. For postoperative pain relief, the patient will have the opportunity to use a fentanyl bolus according to the patient-controled analgesia protocol. Receives: Procedure: Patient control analgesia; Procedure: General inhalation anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total dose of opioid analgesics
The total amount of consumed fentanyl required for pain relief will be recorded 24 hours after surgery. For this purpose number of fentanyl boluses will be multiplied on dose size for each included patient.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 Jul 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional AnesthesiaStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061223
- Sponsor's protocol ID
- NMSC-02-25
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of the Effectiveness and Safety of Suprainguinal Fascia Iliaca Block (SFIB) and Pericapsular Nerve Group (PENG) Block in the Anesthesia Complex for Total Hip Replacement
- ClinicalTrials.gov ID
- NCT07061223
- Acronym / sponsor ID
- NMSC-02-25
- Conditions
- Regional Anesthesia, Hip Arthroplasty
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of RussiaUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 11 Jul 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.
Total hip replacement is one of the most common orthopedic operations. According to statistical studies, more than 1 million of such surgical interventions are performed annually in the world. The average age of primary hip replacement surgery is 69 y.o.
Modern approaches of control of general anesthesia allow safe performance of different surgical interventions under general anesthesia. However, general anesthesia does not have an effective and long-lasting effect on relieving operational stress compared to neuraxial anesthesia. To achieve a similar effect, it is necessary to adhere to the principle of multimodality of anesthesia, and the most promising method is a combination of general and regional anesthesia. peripheral blocks are described in the literature, aimed at analgesia directly in the hip joint area, and effectively used in orthopedics.
Most blocks are currently performed under ultrasound control, the risk of nerve damage and accidental intravascular administration of local anesthetics is potentially reduced. It was established that the use of ultrasound guidance reduces the number of attempts and the amount of anesthetic administered, as well as reduces the time required to perform a block.
Another predicted effect is a reduction in the doses of opioids and non-steroidal anti-inflammatory drugs (NSAIDs), which can cause gastrointestinal bleeding and have a nephrotoxic effect, and can also depress breathing. It should be noted that patients over 65 y.o., have the highest risks of these side effects.
This study aims to compare the effectiveness and safety of SFIB and PENG block in hip replacement, as well as evaluation of the effectiveness of combined anesthesia in comparison with general anesthesia without the use of peripheral blocks.
Detailed description
Patients will be randomized into three groups group:
Group 1: General anesthesia with SFIB
In this group, under the ultrasound control, a local anesthetic will be injected into the interfacial space of the iliac muscle, in the area of the passage of the deep artery that surrounds the ilium. The block will be performed over the inguinal fold medial to the upper anterior iliac spine. After ultrasound identification of the needle's location in the interfacial space, 40 ml of a 0.5% solution of Ropivacaine will be administered.
Group 2: General anesthesia with PENG block
The block is performed using ultrasound navigation. After identifying the ileo-lumbar tendon, 40 ml of 0.5% Ropivacaine solution is injected under it. Ropivacaine spreads through the hip joint capsule and blocks small sensitive branches of the femoral and obturator nerves.
Group 3: Control group with general inhalation anesthesia
The control group will undergo general inhalation anesthesia with bolus intraoperative administration of Fentanyl before particularly traumatic stages. For postoperative pain relief, the patient will have the opportunity to use a fentanyl bolus according to the patient-controled analgesia protocol.
The following parameters will be evaluated
- Hemodynamic parameters in the intraoperative period
- Intraoperative monitoring of basal metabolic rate using indirect calorimetry
- Monitoring of glucose levels during the most traumatic stages of surgery
- Recording the total dose of opioid analgesics in the perioperative period
- Degree of postoperative pain and analgesic therapy administered
- Block execution time
- Complications of conducting anesthesia
- Degree of patient satisfaction with anesthesia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General anesthesia with SFIB | Experimental | Procedure: SFIB, Procedure: Patient control analgesia, Procedure: General inhalation anaesthesiaIn this group, under the ultrasound control, a local anesthetic will be injected into the interfacial space of the iliac muscle, in the area of the passage of the deep artery that surrounds the ilium. The block will be performed over the inguinal fold medial to the upper anterior iliac spine. After ultrasound identification of the needle's location in the interfacial space, 40 ml of a 0.5% solution of Ropivacaine will be administered. |
| General anesthesia with PENG block | Experimental | Procedure: PENG block, Procedure: Patient control analgesia, Procedure: General inhalation anaesthesiaThe block is performed using ultrasound navigation. After identifying the ileo-lumbar tendon, 40 ml of 0.5% Ropivacaine solution is injected under it. Ropivacaine spreads through the hip joint capsule and blocks small sensitive branches of the femoral and obturator nerves. |
| Control group with general inhalation anesthesia | Other | Procedure: Patient control analgesia, Procedure: General inhalation anaesthesiaThe control group will undergo general inhalation anesthesia with bolus intraoperative administration of Fentanyl before particularly traumatic stages. For postoperative pain relief, the patient will have the opportunity to use a fentanyl bolus according to the patient-controled analgesia protocol. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed, dated informed consent form
- Age from 50 to 75 years
- Indications for primary total hip replacement
- American Society of Anesthesiologists (ASA) score from 1 to 3
Key exclusion criteria (9 listed)
- Patients receiving beta blockers;
- Infectious manifestations at the puncture site;
- Bleeding, clinically significant hypovolemia of any origin, shock;
- Disorders of the blood coagulation system;
- Intolerance to local anesthetics;
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 |
|---|---|---|
| SFIBThe block technique is based on administration of a local anesthetic under the iliac fascia to block the femoral, lateral femoral cutaneous, and obturator nerves. It is assumed that further leakage of local anesthetic through the interfascial space leads to blocking of the branches of the lumbar plexus in the small pelvis. | Procedure or surgery | General anesthesia with SFIB |
| PENG blockThe hip capsule is the main source of pain because the innervation of the joint capsule is a developed network of articular branches of the femoral, sciatic and obturator nerves. The main idea of this technique is to block these branches at the point of common passage between the tendon of the lumbar muscle and the crest of the pubic bone. The block technique is based on administration of a local anesthetic under the ileo-lumbar tendon. Anesthetic spreads through the hip joint capsule and blocks small sensitive branches of the femoral and obturator nerves. | Procedure or surgery | General anesthesia with PENG block |
| Patient control analgesiaIn the postoperative period, if pain occurs, the patient will be offered the opportunity to use 20 ug Fentanyl solution bolus according to the patient control analgesia (PCA) without a basic infusion. | Procedure or surgery | Control group with general inhalation anesthesia, General anesthesia with PENG block, General anesthesia with SFIB |
| General inhalation anaesthesiaGeneral inhalation anesthesia will be performed in all groups, Desflurane with a minimal alveolar concentration (MAC) of 0.6-0.8 will be used for maintenance | Procedure or surgery | Control group with general inhalation anesthesia, General anesthesia with PENG block, General anesthesia with SFIB |
Primary outcome
Total dose of opioid analgesics
Time frame: 24 hours after surgery
The total amount of consumed fentanyl required for pain relief will be recorded 24 hours after surgery. For this purpose number of fentanyl boluses will be multiplied on dose size for each included patient.
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 11 Jul 2025.
- Individual participant dataSharing planned: Yes
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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 SFIB, PENG block and General inhalation anaesthesia in people with Regional Anesthesia and Hip Arthroplasty, run by State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia at 1 site in Russia.
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 11 Jul 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 Russia. 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?
Total dose of opioid analgesics (time frame: 24 hours after surgery). 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 11 Jul 2025.