Efficacy of Dexmedetomidine As an Adjuvant to Bupivacaine in Pericapsular Nerve Group Block in Hip Replacement Surgeries
NCT ID: NCT06736392
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2025-03-01
2027-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
group C
(Group-C (control) (n=30); will have PENG block using 20ml of isobaric bupivacaine 0.25%
Ultrasound guided Pericapsular Nerve Group Block
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%
group c will receive PENG block with only 20ml isobaric bupivacaine 0.25%
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
a standard echogenic 20-22 gauge 100mm needle
the two groups will receive the PENG block using a standard echogenic 20-22 gauge 100mm needle
group D
Group-D (n=30); will have PENG block with 1.5μg/kg dexmedetomidine as an adjuvant to 20ml of isobaric bupivacaine 0.25%
Ultrasound guided Pericapsular Nerve Group Block
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.
20 ml isobaric bupivacaine 0.25% and 1.5μg/kg dexmedetomidine
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)
the two groups will receive the PENG block under ultrasound guidance
a standard echogenic 20-22 gauge 100mm needle
the two groups will receive the PENG block using a standard echogenic 20-22 gauge 100mm needle
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ultrasound guided Pericapsular Nerve Group Block
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%
group c will receive PENG block with only 20ml isobaric bupivacaine 0.25%
20 ml isobaric bupivacaine 0.25% and 1.5μg/kg dexmedetomidine
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)
the two groups will receive the PENG block under ultrasound guidance
a standard echogenic 20-22 gauge 100mm needle
the two groups will receive the PENG block using a standard echogenic 20-22 gauge 100mm needle
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* Patient with infection at the site of injection
* Patient with coagulopathy
* Patients with known allergy to used medications.
* Psychiatric disorder
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assiut University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mahmoud Mamdooh Wardany
DOCTOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mohamed Mohamed Abd Ellatif
Role: STUDY_DIRECTOR
Anesthesia, Intensive Care and Pain management ,Faculty of medicine, Assiut University
Shereen Mamdooh Mohamed
Role: STUDY_DIRECTOR
Anesthesia, Intensive Care and Pain management South Egypt Cancer Institute, Assiut University
Moaaz Mohamed Tohamy
Role: STUDY_DIRECTOR
Anesthesia, Intensive Care and Pain management South Egypt Cancer Institute, Assiut University
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Dexmedetomidine in PENG block
Identifier Type: -
Identifier Source: org_study_id