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
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
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- 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.