Post Operative PainNCT07153575
Postoperative Analgesia in Hip Arthroplasty
A study testing suprainguinal fascia iliaca block and Pericapsular nerve group (PENG) block in people with Post Operative Pain and Postoperative Nausea and Vomiting, run by Balikesir University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to compare the analgesic effectiveness of two blocks in hip arthroplasty. The main question it aims to answer is -Which block is more efficient? Researchers will compare the suprainguinal fascia iliaca block with the pericapsular nerve group block. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post Operative Pain, Postoperative Nausea and Vomiting, Hip Osteoarthritis
- What is being tested?
- suprainguinal fascia iliaca block and Pericapsular nerve group (PENG) block
- Type of treatment
- Pill or oral medicine, 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
- 12 Mar 2024to 25 Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteer patients undergoing hip arthroplasty
- Voluntary patient to undergo elective operation under regional anaesthesia
- ASA I-II-III
- BMI≤35 kg/m²
Who cannot join
- Obstacles to the application of regional anaesthesia
- Local Anaesthetic Allergy
- Coagulopathy
- Psychiatric disorders and medication
- Hematological/Oncological disease
- Severe organ failure
Show all 12Show fewer
- Multiple bone fractures
- Alcohol/Drug addiction
- Used analgesic medication up to 12 hours before surgery
- Infection at the Block Application Site
- Mental Deficiency
- Morbidly obese patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Postoperative Analgesic Effectiveness of Suprainguinal Fascia Iliaca Block (SFIB) and Pericapsular Nerve Group (PENG) Block in Hip Arthroplasty
The goal of this clinical trial is to compare the analgesic effectiveness of two blocks in hip arthroplasty. The main question it aims to answer is
-Which block is more efficient? Researchers will compare the suprainguinal fascia iliaca block with the pericapsular nerve group block.
Participants will be randomized, and one of the blocks will be applied.
Read the detailed description
Postoperative pain and analgesia in hip surgery is an important issue for early mobilization and length of hospital stay. The patient population is usually elderly. Prolonged hospital stay may cause thromboembolic complications due to delayed mobilization, psychiatric conditions such as delirium, and many undesirable conditions caused by pain such as chronicisation of acute pain. There are neuraxial analgesia, regional analgesia and multimodal analgesia regimens that are used together to prevent postoperative pain and to prevent these undesirable conditions caused by pain. Suprainguinal fascia iliaca block and pericapsular nerve group blocks are two of those. With performing these blocks, we will obtain postoperative analgesia and avoid postoperative complications.
- Being tested
- suprainguinal fascia iliaca block, Pericapsular nerve group (PENG) block
- Keywords
- Hip Arthroplasty, Postoperative analgesia, Suprainguinal fascia iliaca block, Pericapsular nerve group block
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suprainguinal fascia iliaca blockProcedure or surgery
The ultrasound-guided suprainguinal fascia iliaca block (SFIB) procedure was first described by Hebbard et al. in 2011. It is a prevalent regional anesthesia technique employed in surgical procedures involving the hip joint and femur. Local anesthetics are administered in close proximity to the fascia iliaca. The primary objective is to obstruct the femoral, obturator and lateral femoral cutaneous nerve in a simultaneous manner. In clinical practice, it is a safe and simple alternative to lumbar plexus blocks and femoral blocks. A 30-ml solution of 0.25% bupivacaine was injected between the iliac muscle and the iliac fascia. The bupivacaine dosage administered in the study was standardized for the groups by employing equal concentrations and volumes.
Pericapsular nerve group (PENG) blockProcedure or surgery
In pericapsular nerve group (PENG) block the local anesthetic agent is injected into the musculofascial plane between the psoas muscle tendon and the pubic ramus. The primary objective of this technique is to obstruct the articular branches of the femoral, obturator, and accessory obturator which innervate the hip capsule. Therefore, a comparison with the SFIB was undertaken. A 30-ml block of 0.25% bupivacaine solution was injected between the pubic ramus and the iliopsoas muscle tendon. The bupivacaine dosage administered in the study was standardized for the groups by employing equal concentrations and volumes.
| Study group | Role | What they receive |
|---|---|---|
| Suprainguinal fascia iliaca block | Active comparator | The ultrasound-guided suprainguinal fascia iliaca block (SFIB) procedure was first described by Hebbard et al. in 2011. It is a prevalent regional anesthesia technique employed in surgical procedures involving the hip joint and femur. Local anesthetics are administered in close proximity to the fascia iliaca. The primary objective is to obstruct the femoral, obturator and lateral femoral cutaneous nerve in a simultaneous manner. In clinical practice, it is a safe and simple alternative to lumbar plexus blocks and femoral blocks. A 30-ml solution of 0.25% bupivacaine was injected between the iliac muscle and the iliac fascia. The bupivacaine dosage administered in the study was standardized for the groups by employing equal concentrations and volumes. Receives: Procedure: suprainguinal fascia iliaca block |
| Pericapsular nerve group block | Active comparator | In pericapsular nerve group (PENG) block the local anesthetic agent is injected into the musculofascial plane between the psoas muscle tendon and the pubic ramus. The primary objective of this technique is to obstruct the articular branches of the femoral, obturator, and accessory obturator which innervate the hip capsule. Therefore, a comparison with the SFIB was undertaken. A 30-ml block of 0.25% bupivacaine solution was injected between the pubic ramus and the iliopsoas muscle tendon. The bupivacaine dosage administered in the study was standardized for the groups by employing equal concentrations and volumes. Receives: Procedure: Pericapsular nerve group (PENG) block |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the postoperative analgesic efficacy of SFIB and PENG block
Calculating total morphine consumption over 24 hours in patients by using patient controlled analgesia pump.
Measured: 24 hours
Secondary outcomes (2)
Postoperative analgesia scores
Detecting postoperative analgesia scores during rest and movement by using Numerical Rating Scale (NRS) scores. The scale ranges from 0 - 10. Zero represents no pain, while 10 represents the worst possible pain.
Measured: 24 hours
Assessment of nausea and vomiting incidence
The incidence of nausea and vomiting was examined at 1, 3, 6, 12, 18, and 24 hours post-intervention. The data were analyzed across groups using a 4-point categorical scoring system, with the following definitions: No nausea: 0; Mild: 1; Moderate: 2; Severe: 3.
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 posted4 Sep 2025
- Study start12 Mar 2024
- Primary completion25 Dec 2024
- Study completion25 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Ugun, Balikesir University
- Investigators
- Fatih Ugün, M.D., Principal investigator, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153575
- Sponsor's protocol ID
- 2023/142
- Other IDs
- 23-AKD-282
- Status last verified
- Sep 2026
- First submitted
- 3 May 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD throughout the trial will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Postoperative Analgesic Effectiveness of Suprainguinal Fascia Iliaca Block (SFIB) and Pericapsular Nerve Group (PENG) Block in Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT07153575
- Acronym / sponsor ID
- 2023/142
- Keywords
- Hip Arthroplasty, Postoperative analgesia, Suprainguinal fascia iliaca block, Pericapsular nerve group block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 25 Dec 2024 (actual)
- Study completion
- 25 Dec 2024 (actual)
- First posted
- 4 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.
The goal of this clinical trial is to compare the analgesic effectiveness of two blocks in hip arthroplasty. The main question it aims to answer is
-Which block is more efficient? Researchers will compare the suprainguinal fascia iliaca block with the pericapsular nerve group block.
Participants will be randomized, and one of the blocks will be applied.
Detailed description
Postoperative pain and analgesia in hip surgery is an important issue for early mobilization and length of hospital stay. The patient population is usually elderly. Prolonged hospital stay may cause thromboembolic complications due to delayed mobilization, psychiatric conditions such as delirium, and many undesirable conditions caused by pain such as chronicisation of acute pain. There are neuraxial analgesia, regional analgesia and multimodal analgesia regimens that are used together to prevent postoperative pain and to prevent these undesirable conditions caused by pain. Suprainguinal fascia iliaca block and pericapsular nerve group blocks are two of those. With performing these blocks, we will obtain postoperative analgesia and avoid postoperative complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suprainguinal fascia iliaca block | Active comparator | Procedure: suprainguinal fascia iliaca blockThe ultrasound-guided suprainguinal fascia iliaca block (SFIB) procedure was first described by Hebbard et al. in 2011. It is a prevalent regional anesthesia technique employed in surgical procedures involving the hip joint and femur. Local anesthetics are administered in close proximity to the fascia iliaca. The primary objective is to obstruct the femoral, obturator and lateral femoral cutaneous nerve in a simultaneous manner. In clinical practice, it is a safe and simple alternative to lumbar plexus blocks and femoral blocks. A 30-ml solution of 0.25% bupivacaine was injected between the iliac muscle and the iliac fascia. The bupivacaine dosage administered in the study was standardized for the groups by employing equal concentrations and volumes. |
| Pericapsular nerve group block | Active comparator | Procedure: Pericapsular nerve group (PENG) blockIn pericapsular nerve group (PENG) block the local anesthetic agent is injected into the musculofascial plane between the psoas muscle tendon and the pubic ramus. The primary objective of this technique is to obstruct the articular branches of the femoral, obturator, and accessory obturator which innervate the hip capsule. Therefore, a comparison with the SFIB was undertaken. A 30-ml block of 0.25% bupivacaine solution was injected between the pubic ramus and the iliopsoas muscle tendon. The bupivacaine dosage administered in the study was standardized for the groups by employing equal concentrations and volumes. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Volunteer patients undergoing hip arthroplasty
- Voluntary patient to undergo elective operation under regional anaesthesia
- ASA I-II-III
- BMI≤35 kg/m²
Key exclusion criteria (12 listed)
- Obstacles to the application of regional anaesthesia
- Local Anaesthetic Allergy
- Coagulopathy
- Psychiatric disorders and medication
- Hematological/Oncological disease
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 |
|---|---|---|
| suprainguinal fascia iliaca blockThe ultrasound-guided suprainguinal fascia iliaca block (SFIB) procedure was first described by Hebbard et al. in 2011. It is a prevalent regional anesthesia technique employed in surgical procedures involving the hip joint and femur. Local anesthetics are administered in close proximity to the fascia iliaca. The primary objective is to obstruct the femoral, obturator and lateral femoral cutaneous nerve in a simultaneous manner. In clinical practice, it is a safe and simple alternative to lumbar plexus blocks and femoral blocks. A 30-ml solution of 0.25% bupivacaine was injected between the iliac muscle and the iliac fascia. The bupivacaine dosage administered in the study was standardized for the groups by employing equal concentrations and volumes. | Procedure or surgery | Suprainguinal fascia iliaca block |
| Pericapsular nerve group (PENG) blockIn pericapsular nerve group (PENG) block the local anesthetic agent is injected into the musculofascial plane between the psoas muscle tendon and the pubic ramus. The primary objective of this technique is to obstruct the articular branches of the femoral, obturator, and accessory obturator which innervate the hip capsule. Therefore, a comparison with the SFIB was undertaken. A 30-ml block of 0.25% bupivacaine solution was injected between the pubic ramus and the iliopsoas muscle tendon. The bupivacaine dosage administered in the study was standardized for the groups by employing equal concentrations and volumes. | Procedure or surgery | Pericapsular nerve group block |
Primary outcome
To compare the postoperative analgesic efficacy of SFIB and PENG block
Time frame: 24 hours
Calculating total morphine consumption over 24 hours in patients by using patient controlled analgesia pump.
2 secondary outcomes
Postoperative analgesia scores
Time frame: 24 hours
Assessment of nausea and vomiting incidence
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 16 Sep 2026.
- Ultrasound-guided, direct suprainguinal injection for fascia iliaca block for total hip arthroplasty: A retrospective studyLink provided by the sponsor.
- Comparison of conventional infrainguinal versus modified proximal suprainguinal approach of Fascia Iliaca Compartment Block for postoperative analgesia in Total Hip Arthroplasty. A prospective randomized studyLink provided by the sponsor.
- Comparative evaluation of femoral nerve block and intravenous fentanyl for positioning during spinal anaesthesia in surgery of femur fractureLink provided by the sponsor.
- Comparison of pericapsular nerve group (PENG) block with fascia iliaca compartment block (FICB) for pain control in hip fractures: A double-blind prospective randomized controlled clinical trialLink provided by the sponsor.
- Ultrasound guided Fascia Iliaca Block versus Pericapsular Nerve Group for Postoperative Analgesia Prior to Spinal Anaesthesia for Hip SurgeriesLink provided by the sponsor.
- Effectiveness of perineural administration of dexamethasone with lidocaine on onset time of sensory block and early postoperative analgesia in axillary brachial plexus block: a prospective cohort study, EthiopiaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected IPD throughout the trial will be shared.
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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.
Fatih Ugün, M.D. principal investigator
Balikesir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing suprainguinal fascia iliaca block and Pericapsular nerve group (PENG) block in people with Post Operative Pain and Postoperative Nausea and Vomiting, run by Balikesir 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 12 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 16 Sep 2026. 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?
To compare the postoperative analgesic efficacy of SFIB and PENG block (time frame: 24 hours). 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 16 Sep 2026.