Efficacy of Dexmedetomidine As an Adjuvant to Bupivacaine in Pericapsular Nerve Group Block in Hip Replacement Surgeries

NCT06736392 | Not Yet Recruiting Phase 2 FDA Drug FDA Device

• 1 other identifier: Dexmedetomidine in PENG block
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

• 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)

Conditions

PENG Block

Outcome Measures

Primary Outcomes (1)

• total amount of postoperative morphine consumption in the first 24h postoperative.

  within the first 24 hours postoperatively

Secondary Outcomes (1)

• the intensity of postoperative pain assessed by the Visual Analog Scale for pain

  within the first 24 hours postoperatively

Study Arms (2)

group C

ACTIVE COMPARATOR

(Group-C (control) (n=30); will have PENG block using 20ml of isobaric bupivacaine 0.25%

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%

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

Interventions

Ultrasound guided Pericapsular Nerve Group Block PROCEDURE

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.

group C; group D

Isobaric Bupivacaine 0. 25% DRUG

group c will receive PENG block with only 20ml isobaric bupivacaine 0.25%

group C

20 ml isobaric bupivacaine 0.25% and 1.5μg/kg dexmedetomidine DRUG

group D will receive PENG block with 20 ml isobaric bupivacaine 0.25% and 1.5μg/kg dexmedetomidine

group D

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

group C; group D

a standard echogenic 20-22 gauge 100mm needle DEVICE

the two groups will receive the PENG block using a standard echogenic 20-22 gauge 100mm needle

group C; group D

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Dexmedetomidine; Needles

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Equipment and Supplies

Study Officials

• Mohamed Mohamed Abd Ellatif

  Anesthesia, Intensive Care and Pain management ,Faculty of medicine, Assiut University

  STUDY DIRECTOR

• Shereen Mamdooh Mohamed

  Anesthesia, Intensive Care and Pain management South Egypt Cancer Institute, Assiut University

  STUDY DIRECTOR

• Moaaz Mohamed Tohamy

  Anesthesia, Intensive Care and Pain management South Egypt Cancer Institute, Assiut University

  STUDY DIRECTOR

Central Study Contacts

Mahmoud Mamdooh Wardany

CONTACT

+201032899985; mahmoudwardany544@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DOCTOR

Model Details: 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.

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 16, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 16, 2024

Record last verified: 2024-12