AnesthesiaNCT06916000
Assessment of PENG Block as a Part of Multimodal Analgesia Following Hip Surgeries.
A study testing Pericapsular nerve group (PENG) block and Patients will receive only other multimodal analgesics including LCFN block via 10 ml of 0.25% bupivacaine. in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
to study the effect of Pericapsular nerve group (PENG) block as a part of multimodal analgesia regimen for hip arthroplasties Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- Pericapsular nerve group (PENG) block and Patients will receive only other multimodal analgesics including LCFN block via 10 ml of 0.25% bupivacaine.
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Jun 2024to Jun 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age group: 18 years and older.
- ASA classification I to III.
- BMI : 18-35 .
- Gender: both sex
Who cannot join
- Patient refusal.
- Patients on long-term pain medications.
- History of allergic reactions to local anesthetics
- Patients who had mental illness or uncooperative patients.
- BMI > 35 .
- Patients having coagulopathies or on anticoagulant or antiplatelet therapy.
Show all 9Show fewer
- Severe cardiopulmonary disease
- ASA IV or more
- Diabetic or other neuropathies
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of medicine, Ain Shams University
Abbasia, Cairo Governorate, 11517
About this study
Official title: Effect of Ultrasound Guided Pericapsular Nerve Group (PENG) Block on Perioperative Pain Management in Patients Undergoing Hip Arthroplasty
to study the effect of Pericapsular nerve group (PENG) block as a part of multimodal analgesia regimen for hip arthroplasties
Read the detailed description
PENG block is a novel block described by Giron-Arango in 2018 to anesthesize the anterior hip capsule as it is supplied by branches from femoral, obturator and accessory obturator nerves, sparing motor function is an additional significance So currently the block is used to reduce post operative opioid consumption, delay time rescue analgesia, facilitate positioning for spinal anesthesia for hip surgeries and to accelerate mobility and so hospital discharge saving this vulnerable group of patient from any hospital acquired pneumonia, decreasing hospital stays, and improving recovery times would provide valuable insights into its cost-effectiveness and long-term benefits for healthcare system Our primary outcome to be studied is pain assessment via Numer Rating Scale over 24 hours postoperatively, in addition to to secondary outcomes including the aforementioned advantages.
- Conditions
- Anesthesia
- Being tested
- Pericapsular nerve group (PENG) block, Patients will receive only other multimodal analgesics including LCFN block via 10 ml of 0.25% bupivacaine.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular nerve group (PENG) blockDrug
As a part of multimodal analgesia patients will receive 20 ml of 0.25% bupivcacaine according to the technique described by Giron-Arango.
All patients will receive the same analgesic protocol, which included IV paracetamol 1000 mg BID and NSAIDs if no contra-indication; PO celecoxib 100 mg BID. Also if needed nalbuphine 5 mg IV will be given as bolus demand dose and when the NRS pain score was equal to or greater than 4 points.
Patients will receive only other multimodal analgesics including LCFN block via 10 ml of 0.25% bupivacaine.Other
Patients will receive only other multimodal analgesics including LCFN block via 10 ml of 0.25% bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| PENG block group (25 particiants) | Active comparator | For postoperative pain management, all patients of this arm will receive 20 ml of 0.25% bupivcacaine according to the technique described by Giron-Arango.
In addition, multimodal analgesia will be given including IV paracetamol 1000 mg BID and oral celecoxib tablet 100 mg BID. Also if needed nalbuphine 5 mg IV will be given as demand dose and when the NRS pain score was equal to or greater than 4 points. Receives: Drug: Pericapsular nerve group (PENG) block |
| Group C: control group (25 participants) | Experimental | Patients will receive only other multimodal analgesics Receives: Other: Patients will receive only other multimodal analgesics including LCFN block via 10 ml of 0.25% bupivacaine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score: pain assessment using a Numeric Rating System (NRS) immediately in the postoperative period.
Pain score: pain intensity will be evaluated using a Numeric Rating System (NRS) immediately in the postoperative period, every 2 hours during the first 6 hours and then every 6 hours till 24 hours postoperatively. Scores ranging from 0 to 10, with 0 indicating the absence of pain and 10 indicating the worst possible pain.
Measured: 24 hours
Secondary outcomes (1)
Rescue analgesia timing and opioid consumption over 24 hours
Time to first opioid demand and total opioid consumed by each patient individually over 24 hours.
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 posted8 Apr 2025
- Study start27 Jun 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916000
- Sponsor's protocol ID
- FMASU MS428/2024
- Status last verified
- Jan 2025
- First submitted
- 28 Nov 2024
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound Guided Pericapsular Nerve Group (PENG) Block on Perioperative Pain Management in Patients Undergoing Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT06916000
- Acronym / sponsor ID
- FMASU MS428/2024
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 8 Apr 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.
to study the effect of Pericapsular nerve group (PENG) block as a part of multimodal analgesia regimen for hip arthroplasties
Detailed description
PENG block is a novel block described by Giron-Arango in 2018 to anesthesize the anterior hip capsule as it is supplied by branches from femoral, obturator and accessory obturator nerves, sparing motor function is an additional significance So currently the block is used to reduce post operative opioid consumption, delay time rescue analgesia, facilitate positioning for spinal anesthesia for hip surgeries and to accelerate mobility and so hospital discharge saving this vulnerable group of patient from any hospital acquired pneumonia, decreasing hospital stays, and improving recovery times would provide valuable insights into its cost-effectiveness and long-term benefits for healthcare system Our primary outcome to be studied is pain assessment via Numer Rating Scale over 24 hours postoperatively, in addition to to secondary outcomes including the aforementioned advantages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENG block group (25 particiants) | Active comparator | Drug: Pericapsular nerve group (PENG) blockFor postoperative pain management, all patients of this arm will receive 20 ml of 0.25% bupivcacaine according to the technique described by Giron-Arango. In addition, multimodal analgesia will be given including IV paracetamol 1000 mg BID and oral celecoxib tablet 100 mg BID. Also if needed nalbuphine 5 mg IV will be given as demand dose and when the NRS pain score was equal to or greater than 4 points. |
| Group C: control group (25 participants) | Experimental | Other: Patients will receive only other multimodal analgesics including LCFN block via 10 ml of 0.25% bupivacaine.Patients will receive only other multimodal analgesics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age group: 18 years and older.
- ASA classification I to III.
- BMI : 18-35 .
- Gender: both sex
Key exclusion criteria (9 listed)
- Patient refusal.
- Patients on long-term pain medications.
- History of allergic reactions to local anesthetics
- Patients who had mental illness or uncooperative patients.
- BMI > 35 .
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 |
|---|---|---|
| Pericapsular nerve group (PENG) blockAs a part of multimodal analgesia patients will receive 20 ml of 0.25% bupivcacaine according to the technique described by Giron-Arango. All patients will receive the same analgesic protocol, which included IV paracetamol 1000 mg BID and NSAIDs if no contra-indication; PO celecoxib 100 mg BID. Also if needed nalbuphine 5 mg IV will be given as bolus demand dose and when the NRS pain score was equal to or greater than 4 points. | Drug | PENG block group (25 particiants) |
| Patients will receive only other multimodal analgesics including LCFN block via 10 ml of 0.25% bupivacaine.Patients will receive only other multimodal analgesics including LCFN block via 10 ml of 0.25% bupivacaine. | Other | Group C: control group (25 participants) |
Primary outcome
Pain score: pain assessment using a Numeric Rating System (NRS) immediately in the postoperative period.
Time frame: 24 hours
Pain score: pain intensity will be evaluated using a Numeric Rating System (NRS) immediately in the postoperative period, every 2 hours during the first 6 hours and then every 6 hours till 24 hours postoperatively. Scores ranging from 0 to 10, with 0 indicating the absence of pain and 10 indicating the worst possible pain.
1 secondary outcome
Rescue analgesia timing and opioid consumption over 24 hours
Time frame: 24 hours
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 8 Apr 2025.
- Individual participant dataSharing planned: No
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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 Pericapsular nerve group (PENG) block and Patients will receive only other multimodal analgesics including LCFN block via 10 ml of 0.25% bupivacaine. in people with Anesthesia, 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 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: under way, not looking for participants, as of the sponsor's last update on 8 Apr 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 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?
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?
Pain score: pain assessment using a Numeric Rating System (NRS) immediately in the postoperative period. (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 8 Apr 2025.