Postoperative AnalgesiaNCT06003738
Postoperative Analgesia After Total Hip Arthroplasty: Comparative Evaluation of Pericapsular Nerve Group Versus Fascia Iliaca Compartment Block
A study testing Fascia iliaca compartment block and Pericapsular nerve group block in people with Postoperative Analgesia and Total Hip Arthroplasty, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the effectiveness of pericapsular nerve group (PENG) block versus fascia iliaca compartment block (FICB) for postoperative pain relief following total hip arthroplasty (THA). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Analgesia, Total Hip Arthroplasty, Pericapsular Nerve Group Block
- What is being tested?
- Fascia iliaca compartment block and Pericapsular nerve group block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 1 Sep 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 80 years.
- Both sexes.
- American Society of Anaesthesiologists (ASA) Physical Status II-III.
- Scheduled for Total hip arthroplasty (THA) under spinal anesthesia.
Who cannot join
- Patients' refusal
- Contraindications to spinal anesthesia or nerve blocks.
- History of allergy to the medications used in the study.
- Pregnancy.
- Significant cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Analgesia After Total Hip Arthroplasty: Comparative Evaluation of Pericapsular Nerve Group Versus Fascia Iliaca Compartment Block in a Randomized Controlled Trial
The aim of this study is to compare the effectiveness of pericapsular nerve group (PENG) block versus fascia iliaca compartment block (FICB) for postoperative pain relief following total hip arthroplasty (THA).
Read the detailed description
Total hip arthroplasty is a widely used surgical treatment intervention for treating hip conditions such as femur neck fractures and advanced hip osteoarthritis.
Hip fractures are quite common, regardless of the age of the population (young or old), and they are extremely painful. A hip fracture is a serious injury with potentially life-threatening complications, and it is a common orthopedic emergency in elderly individuals. Early surgery within 48 hours of a fracture has been found to lower mortality and complication rates.
The pericapsular nerve group block is a novel regional analgesia technique to decrease pain after total hip arthroplasty (THA) while preserving the motor function. The local anaesthetic is deposited using this method in the fascial plane between the psoas muscle and the superior pubic ramus, which aims sensory branches of the obturator, accessory obturator, and femoral nerves in the anterior capsule of the hip.
Fascia iliaca compartment block, for procedures on the femur and hip joint, is still a well-liked regional anaesthetic technique. Studies have found that FICB prevents complications by anaesthetizing the femoral nerve far from critical neurovascular structures while still giving enough analgesia.
Both blocks could be used to effectively reduce pain intensity up to 24 hours, total opioid consumption, and length of hospital stay in THA patients.
- Conditions
- Postoperative Analgesia, Total Hip Arthroplasty, Pericapsular Nerve Group Block, Fascia Iliaca Compartment Block
- Being tested
- Fascia iliaca compartment block, Pericapsular nerve group block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascia iliaca compartment blockOther
Patients received an ultrasound-guided supra-inguinal fascia iliaca compartment block.
Pericapsular nerve group blockOther
Patients received an ultrasound-guided pericapsular nerve group (PENG) block.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients received an ultrasound-guided supra-inguinal fascia iliaca compartment block. Receives: Other: Fascia iliaca compartment block |
| Group B | Active comparator | Patients received an ultrasound-guided pericapsular nerve group (PENG) block. Receives: Other: Pericapsular nerve group block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain
Degree of pain was assessed using the Visual Analogue Scale (VAS). VAS is ranging from 0 to 10, where 0 is no pain and 10 is maximum pain. VAS was recorded at 0, 2, 4, 6, 12, 18, and 24 hours postoperatively.
Measured: 24 hours postoperatively
Total amount of nalbuphine consumption
If the postoperative Visual Analogue Scale (VAS) was greater than 3, an intravenous dose of 5 mg Nalbuphine diluted in 5 mL of saline was administered as needed.
Measured: 24 hours postoperatively
Number of cases needing rescue doses
The number of cases needing rescue doses was recorded.
Measured: 24 hours postoperatively
Secondary outcomes (1)
Postoperative ambulation
Time from completion of surgery to first assisted standing and walking ≥2 meters was recorded as the ambulation time.
Measured: 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 posted22 Aug 2023
- Study start1 Sep 2023
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diaaeldin Badr Aboelnile, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003738
- Sponsor's protocol ID
- FMASU MD76/2023
- Status last verified
- Aug 2026
- First submitted
- 12 Jul 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesia After Total Hip Arthroplasty: Comparative Evaluation of Pericapsular Nerve Group Versus Fascia Iliaca Compartment Block in a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06003738
- Acronym / sponsor ID
- FMASU MD76/2023
- Conditions
- Postoperative Analgesia, Total Hip Arthroplasty, Pericapsular Nerve Group Block, Fascia Iliaca Compartment Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 22 Aug 2023 (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 aim of this study is to compare the effectiveness of pericapsular nerve group (PENG) block versus fascia iliaca compartment block (FICB) for postoperative pain relief following total hip arthroplasty (THA).
Detailed description
Total hip arthroplasty is a widely used surgical treatment intervention for treating hip conditions such as femur neck fractures and advanced hip osteoarthritis.
Hip fractures are quite common, regardless of the age of the population (young or old), and they are extremely painful. A hip fracture is a serious injury with potentially life-threatening complications, and it is a common orthopedic emergency in elderly individuals. Early surgery within 48 hours of a fracture has been found to lower mortality and complication rates.
The pericapsular nerve group block is a novel regional analgesia technique to decrease pain after total hip arthroplasty (THA) while preserving the motor function. The local anaesthetic is deposited using this method in the fascial plane between the psoas muscle and the superior pubic ramus, which aims sensory branches of the obturator, accessory obturator, and femoral nerves in the anterior capsule of the hip.
Fascia iliaca compartment block, for procedures on the femur and hip joint, is still a well-liked regional anaesthetic technique. Studies have found that FICB prevents complications by anaesthetizing the femoral nerve far from critical neurovascular structures while still giving enough analgesia.
Both blocks could be used to effectively reduce pain intensity up to 24 hours, total opioid consumption, and length of hospital stay in THA patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Fascia iliaca compartment blockPatients received an ultrasound-guided supra-inguinal fascia iliaca compartment block. |
| Group B | Active comparator | Other: Pericapsular nerve group blockPatients received an ultrasound-guided pericapsular nerve group (PENG) block. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18 to 80 years.
- Both sexes.
- American Society of Anaesthesiologists (ASA) Physical Status II-III.
- Scheduled for Total hip arthroplasty (THA) under spinal anesthesia.
Key exclusion criteria (5 listed)
- Patients' refusal
- Contraindications to spinal anesthesia or nerve blocks.
- History of allergy to the medications used in the study.
- Pregnancy.
- Significant cognitive impairment.
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 |
|---|---|---|
| Fascia iliaca compartment blockPatients received an ultrasound-guided supra-inguinal fascia iliaca compartment block. | Other | Group A |
| Pericapsular nerve group blockPatients received an ultrasound-guided pericapsular nerve group (PENG) block. | Other | Group B |
Primary outcome
Degree of pain
Time frame: 24 hours postoperatively
Degree of pain was assessed using the Visual Analogue Scale (VAS). VAS is ranging from 0 to 10, where 0 is no pain and 10 is maximum pain. VAS was recorded at 0, 2, 4, 6, 12, 18, and 24 hours postoperatively.
Total amount of nalbuphine consumption
Time frame: 24 hours postoperatively
If the postoperative Visual Analogue Scale (VAS) was greater than 3, an intravenous dose of 5 mg Nalbuphine diluted in 5 mL of saline was administered as needed.
Number of cases needing rescue doses
Time frame: 24 hours postoperatively
The number of cases needing rescue doses was recorded.
1 secondary outcome
Postoperative ambulation
Time frame: 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 13 Aug 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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?
A study testing Fascia iliaca compartment block and Pericapsular nerve group block in people with Postoperative Analgesia and Total Hip Arthroplasty, run by Ain Shams University at 1 site in Egypt.
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 5 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 13 Aug 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 Egypt. 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?
Degree of pain (time frame: 24 hours postoperatively). The study lists 3 primary outcomes in all. 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 13 Aug 2026.