PENG BlockPhase 2NCT06736392
Efficacy of Dexmedetomidine As an Adjuvant to Bupivacaine in Pericapsular Nerve Group Block in Hip Replacement Surgeries
A Phase 2 study testing Ultrasound guided Pericapsular Nerve Group Block, Isobaric Bupivacaine 0. 25% and 20 ml isobaric bupivacaine 0.25% and 1.5μg/kg dexmedetomidine in people with PENG Block, run by Assiut University.
Trial summary
Our aim will be to investigate the efficacy of dexmedetomidine as an adjuvant to bupivacaine in ultrasound guided pericapsular nerve group (PENG) block for postoperative analgesia in hip replacement surgeries. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- PENG Block
- What is being tested?
- Ultrasound guided Pericapsular Nerve Group Block, Isobaric Bupivacaine 0. 25% and 20 ml isobaric bupivacaine 0.25% and 1.5μg/kg dexmedetomidine
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to Mar 2027
- Phase
- Phase 2
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged from 18 years to 90 years
- Gender : both males and females
- BMI less than 35 kg/m2
- Patients with American society of anesthesiologists (ASA) classification class I , II or III
- Patients scheduled for total or partial hip replacement surgery under spinal anesthesia
Who cannot join
- Patient declining to give written informed consent
- Patient with infection at the site of injection
- Patient with coagulopathy
- Patients with known allergy to used medications.
- Psychiatric disorder
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Dexmedetomidine As an Adjuvant to Bupivacaine in Ultrasound Guided Pericapsular Nerve Group Block for Postoperative Analgesia During Spinal Anesthesia in Hip Replacement Surgeries, a Randomized Controlled Study
Our aim will be to investigate the efficacy of dexmedetomidine as an adjuvant to bupivacaine in ultrasound guided pericapsular nerve group (PENG) block for postoperative analgesia in hip replacement surgeries.
- Our primary outcome of the study: total amount of postoperative morphine consumption in the first 24h postoperative.
- Our secondary outcome of the study: postoperative analgesia assessed by pain score (by Visual Analog Scale)
Read the detailed description
Effective postoperative pain management is essential for optimizing recovery and patient outcomes following hip surgeries.
The pericapsular nerve group (PENG) block has gained attention as a regional anesthesia technique that provides targeted analgesia to the hip joint and surrounding structures, reducing opioid consumption and avoiding its side effects as nausea, vomiting, constipation, itching, rash, addiction, urinary retention, respiratory depression especially at higher doses By delivering local anesthetics close to the genicular branches of the femoral nerve, the pericapsular nerve group (PENG) block offers several advantages as part of multimodal analgesia in comparison to other nerve blocks used for hip surgeries, such as the femoral nerve block (FNB) and the lumbar plexus block (LPB) as better pain relief for capsular structures with minimal motor blockade, lower risk of complications and reducing need for opioids making it particularly suitable for orthopedic procedures.
Traditionally, local anesthetics such as bupivacaine have been used in the pericapsular nerve group (PENG) block to achieve effective analgesia. However, despite its long acting properties, their duration of action is typically limited to 6 to 12 hours depending on factors like the concentration, dose and individual patient characteristics and the quality of analgesia may diminish as the anesthetic effect wears off, potentially necessitating additional analgesic interventions or systemic opioids to maintain pain control.
Therefore, there is a growing interest in exploring adjuvants that can enhance the efficacy and duration of pain relief without compromising safety such as Dexmedetomidine, Clonidine, and Dexamethasone.
Dexmedetomidine, a highly selective alpha-2 adrenergic agonist, has emerged as a promising adjuvant in prolonging the duration and improving the quality of peripheral nerve blocks through its potent analgesic and sedative effects, by binding to its receptors, reducing the release of norepinephrine and inhibiting pain transmission , by this mechanism not only enhances sensory blockade but also provides effective postoperative analgesia with minimal motor impairment.
Studies have shown that dexmedetomidine, when added to local anesthetics in various regional anesthesia techniques, including peripheral nerve blocks, significantly prolongs the duration of sensory blockade and improves postoperative pain scores.
Given the potential benefits of dexmedetomidine in enhancing postoperative pain management and reducing opioid requirements, this study aims to evaluate its efficacy as an adjuvant to bupivacaine in the pericapsular nerve group (PENG) block for hip replacement surgeries. By assessing, opioid consumption and pain scores, this research seeks to contribute valuable insights into optimizing analgesic strategies in orthopedic anesthesia.
- Conditions
- PENG Block
- Being tested
- Ultrasound guided Pericapsular Nerve Group Block, Isobaric Bupivacaine 0. 25%, 20 ml isobaric bupivacaine 0.25% and 1.5μg/kg dexmedetomidine, the ultrasound machine with curvilinear transducer (high -frequency probe, 2.5Mhz to 7.5Mhz), a standard echogenic 20-22 gauge 100mm needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided Pericapsular Nerve Group BlockProcedure or surgery
With the patient in the supine position and the leg slightly abducted, a curvilinear transducer (2.5-7.5 MHz) is prepared with sterile conduction gel and covered with a sterile probe cover. The transducer is placed transversely over the anterior superior iliac spine (ASIS), then aligned with the pubic ramus and rotated approximately 45° parallel to the inguinal crease. The probe is slid medially to identify key landmarks: the anterior inferior iliac spine (AIIS), iliopubic eminence (IPE), iliopsoas tendon, femoral artery, and femoral nerve. Sliding the probe distally or tilting caudally exposes the femoral head.
A 20-22 gauge echogenic needle (100 mm) is inserted in-plane from lateral to medial, targeting the plane between the psoas tendon and the pubic ramus. the anesthetic agent is deposited to lift the psoas tendon while avoiding tendon puncture.
Isobaric Bupivacaine 0. 25%Drug
group c will receive PENG block with only 20ml isobaric bupivacaine 0.25%
20 ml isobaric bupivacaine 0.25% and 1.5μg/kg dexmedetomidineDrug
group D will receive PENG block with 20 ml isobaric bupivacaine 0.25% and 1.5μg/kg dexmedetomidine
the ultrasound machine with curvilinear transducer (high -frequency probe, 2.5Mhz to 7.5Mhz)Device
the two groups will receive the PENG block under ultrasound guidance
a standard echogenic 20-22 gauge 100mm needleDevice
the two groups will receive the PENG block using a standard echogenic 20-22 gauge 100mm needle
| Study group | Role | What they receive |
|---|---|---|
| group C | Active comparator | (Group-C (control) (n=30); will have PENG block using 20ml of isobaric bupivacaine 0.25% Receives: Procedure: Ultrasound guided Pericapsular Nerve Group Block; Drug: Isobaric Bupivacaine 0. 25%; Device: the ultrasound machine with curvilinear transducer (high -frequency probe, 2.5Mhz to 7.5Mhz); Device: a standard echogenic 20-22 gauge 100mm needle |
| group D | Active comparator | Group-D (n=30); will have PENG block with 1.5μg/kg dexmedetomidine as an adjuvant to 20ml of isobaric bupivacaine 0.25% Receives: Procedure: Ultrasound guided Pericapsular Nerve Group Block; Drug: 20 ml isobaric bupivacaine 0.25% and 1.5μg/kg dexmedetomidine; Device: the ultrasound machine with curvilinear transducer (high -frequency probe, 2.5Mhz to 7.5Mhz); Device: a standard echogenic 20-22 gauge 100mm needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
total amount of postoperative morphine consumption in the first 24h postoperative.
Measured: within the first 24 hours postoperatively
Secondary outcomes (1)
the intensity of postoperative pain assessed by the Visual Analog Scale for pain
the intensity of postoperative pain assessed by the Visual Analog Scale for pain , which was scored from 0 to 10 where 0= no pain and 10 = the worst pain imaginable at 0,2,4,6,8,10,12,16,24 hours post-operatively to evaluate acute pain
Measured: within the first 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 posted16 Dec 2024
- Study start1 Mar 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PENG BlockStudies of the same condition, open and under way.
- More trials run by Assiut 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A calculated minimum sample of 60 patients candidate for hip replacement surgeries (will have spinal anesthesia with hyperbaric bupivacaine 0.5%) will be randomly assigned into one of two equal groups (1:1 design) (Group-C (control) (n=30); will have PENG block using 20ml of isobaric bupivacaine 0.25% and Group-D (n=30); will have PENG block with 1.5μg/kg dexmedetomidine as an adjuvant to 20ml of isobaric bupivacaine 0.25%, to have 80% power to detect an absolute difference of 0.1 in the mean of the postoperative analgesic consumption in nine repeated measures(at 0,2,4,6,8,10,12,16,24 hours postoperatively), at significance level of 0.05.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mamdooh Wardany, Assiut University
- Investigators
- Mohamed Mohamed Abd Ellatif, Study director, Anesthesia, Intensive Care and Pain management ,Faculty of medicine, Assiut UniversityShereen Mamdooh Mohamed, Study director, Anesthesia, Intensive Care and Pain management South Egypt Cancer Institute, Assiut UniversityMoaaz Mohamed Tohamy, Study director, Anesthesia, Intensive Care and Pain management South Egypt Cancer Institute, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736392
- Sponsor's protocol ID
- Dexmedetomidine in PENG block
- Status last verified
- Dec 2024
- First submitted
- 8 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dexmedetomidine As an Adjuvant to Bupivacaine in Ultrasound Guided Pericapsular Nerve Group Block for Postoperative Analgesia During Spinal Anesthesia in Hip Replacement Surgeries, a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06736392
- Acronym / sponsor ID
- Dexmedetomidine in PENG block
- Conditions
- PENG Block
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 16 Dec 2024 (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.
Our aim will be to investigate the efficacy of dexmedetomidine as an adjuvant to bupivacaine in ultrasound guided pericapsular nerve group (PENG) block for postoperative analgesia in hip replacement surgeries.
- Our primary outcome of the study: total amount of postoperative morphine consumption in the first 24h postoperative.
- Our secondary outcome of the study: postoperative analgesia assessed by pain score (by Visual Analog Scale)
Detailed description
Effective postoperative pain management is essential for optimizing recovery and patient outcomes following hip surgeries.
The pericapsular nerve group (PENG) block has gained attention as a regional anesthesia technique that provides targeted analgesia to the hip joint and surrounding structures, reducing opioid consumption and avoiding its side effects as nausea, vomiting, constipation, itching, rash, addiction, urinary retention, respiratory depression especially at higher doses By delivering local anesthetics close to the genicular branches of the femoral nerve, the pericapsular nerve group (PENG) block offers several advantages as part of multimodal analgesia in comparison to other nerve blocks used for hip surgeries, such as the femoral nerve block (FNB) and the lumbar plexus block (LPB) as better pain relief for capsular structures with minimal motor blockade, lower risk of complications and reducing need for opioids making it particularly suitable for orthopedic procedures.
Traditionally, local anesthetics such as bupivacaine have been used in the pericapsular nerve group (PENG) block to achieve effective analgesia. However, despite its long acting properties, their duration of action is typically limited to 6 to 12 hours depending on factors like the concentration, dose and individual patient characteristics and the quality of analgesia may diminish as the anesthetic effect wears off, potentially necessitating additional analgesic interventions or systemic opioids to maintain pain control.
Therefore, there is a growing interest in exploring adjuvants that can enhance the efficacy and duration of pain relief without compromising safety such as Dexmedetomidine, Clonidine, and Dexamethasone.
Dexmedetomidine, a highly selective alpha-2 adrenergic agonist, has emerged as a promising adjuvant in prolonging the duration and improving the quality of peripheral nerve blocks through its potent analgesic and sedative effects, by binding to its receptors, reducing the release of norepinephrine and inhibiting pain transmission , by this mechanism not only enhances sensory blockade but also provides effective postoperative analgesia with minimal motor impairment.
Studies have shown that dexmedetomidine, when added to local anesthetics in various regional anesthesia techniques, including peripheral nerve blocks, significantly prolongs the duration of sensory blockade and improves postoperative pain scores.
Given the potential benefits of dexmedetomidine in enhancing postoperative pain management and reducing opioid requirements, this study aims to evaluate its efficacy as an adjuvant to bupivacaine in the pericapsular nerve group (PENG) block for hip replacement surgeries. By assessing, opioid consumption and pain scores, this research seeks to contribute valuable insights into optimizing analgesic strategies in orthopedic anesthesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A calculated minimum sample of 60 patients candidate for hip replacement surgeries (will have spinal anesthesia with hyperbaric bupivacaine 0.5%) will be randomly assigned into one of two equal groups (1:1 design) (Group-C (control) (n=30); will have PENG block using 20ml of isobaric bupivacaine 0.25% and Group-D (n=30); will have PENG block with 1.5μg/kg dexmedetomidine as an adjuvant to 20ml of isobaric bupivacaine 0.25%, to have 80% power to detect an absolute difference of 0.1 in the mean of the postoperative analgesic consumption in nine repeated measures(at 0,2,4,6,8,10,12,16,24 hours postoperatively), at significance level of 0.05.
| Arm | Type | Receives |
|---|---|---|
| group C | Active comparator | Procedure: Ultrasound guided Pericapsular Nerve Group Block, Drug: Isobaric Bupivacaine 0. 25%, Device: the ultrasound machine with curvilinear transducer (high -frequency probe, 2.5Mhz to 7.5Mhz), Device: a standard echogenic 20-22 gauge 100mm needle(Group-C (control) (n=30); will have PENG block using 20ml of isobaric bupivacaine 0.25% |
| group D | Active comparator | Procedure: Ultrasound guided Pericapsular Nerve Group Block, Drug: 20 ml isobaric bupivacaine 0.25% and 1.5μg/kg dexmedetomidine, Device: the ultrasound machine with curvilinear transducer (high -frequency probe, 2.5Mhz to 7.5Mhz), Device: a standard echogenic 20-22 gauge 100mm needleGroup-D (n=30); will have PENG block with 1.5μg/kg dexmedetomidine as an adjuvant to 20ml of isobaric bupivacaine 0.25% |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged from 18 years to 90 years
- Gender : both males and females
- BMI less than 35 kg/m2
- Patients with American society of anesthesiologists (ASA) classification class I , II or III
- Patients scheduled for total or partial hip replacement surgery under spinal anesthesia
Key exclusion criteria (5 listed)
- Patient declining to give written informed consent
- Patient with infection at the site of injection
- Patient with coagulopathy
- Patients with known allergy to used medications.
- Psychiatric disorder
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 |
|---|---|---|
| Ultrasound guided Pericapsular Nerve Group BlockWith the patient in the supine position and the leg slightly abducted, a curvilinear transducer (2.5-7.5 MHz) is prepared with sterile conduction gel and covered with a sterile probe cover. The transducer is placed transversely over the anterior superior iliac spine (ASIS), then aligned with the pubic ramus and rotated approximately 45° parallel to the inguinal crease. The probe is slid medially to identify key landmarks: the anterior inferior iliac spine (AIIS), iliopubic eminence (IPE), iliopsoas tendon, femoral artery, and femoral nerve. Sliding the probe distally or tilting caudally exposes the femoral head. A 20-22 gauge echogenic needle (100 mm) is inserted in-plane from lateral to medial, targeting the plane between the psoas tendon and the pubic ramus. the anesthetic agent is deposited to lift the psoas tendon while avoiding tendon puncture. | Procedure or surgery | group C, group D |
| Isobaric Bupivacaine 0. 25%group c will receive PENG block with only 20ml isobaric bupivacaine 0.25% | Drug | group C |
| 20 ml isobaric bupivacaine 0.25% and 1.5μg/kg dexmedetomidinegroup D will receive PENG block with 20 ml isobaric bupivacaine 0.25% and 1.5μg/kg dexmedetomidine | Drug | group D |
| the ultrasound machine with curvilinear transducer (high -frequency probe, 2.5Mhz to 7.5Mhz)the two groups will receive the PENG block under ultrasound guidance | Device | group C, group D |
| a standard echogenic 20-22 gauge 100mm needlethe two groups will receive the PENG block using a standard echogenic 20-22 gauge 100mm needle | Device | group C, group D |
Primary outcome
total amount of postoperative morphine consumption in the first 24h postoperative.
Time frame: within the first 24 hours postoperatively
1 secondary outcome
the intensity of postoperative pain assessed by the Visual Analog Scale for pain
Time frame: within the first 24 hours postoperatively
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 16 Dec 2024.
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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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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.
Mohamed Mohamed Abd Ellatif study director
Anesthesia, Intensive Care and Pain management ,Faculty of medicine, Assiut University
Shereen Mamdooh Mohamed study director
Anesthesia, Intensive Care and Pain management South Egypt Cancer Institute, Assiut University
Moaaz Mohamed Tohamy study director
Anesthesia, Intensive Care and Pain management South Egypt Cancer Institute, Assiut University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ultrasound guided Pericapsular Nerve Group Block, Isobaric Bupivacaine 0. 25% and 20 ml isobaric bupivacaine 0.25% and 1.5μg/kg dexmedetomidine in people with PENG Block, run by Assiut University.
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 5 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: opening soon, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Mahmoud Mamdooh Wardany (+201032899985, mahmoudwardany544@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total amount of postoperative morphine consumption in the first 24h postoperative. (time frame: within the first 24 hours postoperatively). 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 Dec 2024.