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NOT YET RECRUITING
NCT07847047
PHASE3

Safety and Efficacy of Dexamethasone Versus Dexmedetomidine as Adjuvants in PENG Block in Hip Surgeries for Postoperative Pain Management

Sponsor: Assiut University

View on ClinicalTrials.gov

Summary

This study evaluates and compares the analgesic efficacy and safety of adding dexamethasone versus dexmedetomidine to bupivacaine in an ultrasound-guided pericapsular nerve group (PENG) block combined with a lateral femoral cutaneous nerve (LFCN) block in patients undergoing elective total hip replacement under spinal anesthesia. Total hip replacement is associated with substantial acute postoperative pain. The PENG block targets sensory articular branches supplying the hip while preserving quadriceps muscle strength, facilitating early postoperative ambulation. Supplementation with an LFCN block expands sensory coverage to the lateral surgical incision. Adding perineural adjuvants, such as dexamethasone or dexmedetomidine, to local anesthetics may prolong sensory block duration and reduce opioid requirements. A total of 90 adult participants aged 18 to 60 years will be randomly assigned to one of three equal groups (30 patients each): * Group C (Control): Receives a PENG block with 20 mL of plain bupivacaine 0.25%. * Group DX: Receives a PENG block with 20 mL of bupivacaine 0.25% combined with dexamethasone 4 mg. * Group DM: Receives a PENG block with 20 mL of bupivacaine 0.25% combined with dexmedetomidine 1 µg/kg. All participants across all groups will receive an LFCN block with 5 mL of plain bupivacaine 0.25% without adjuvants. The primary outcome is the time to the first request for rescue analgesia (duration of postoperative analgesia). Secondary outcomes include total morphine consumption over the first 24 hours, pain intensity measured using the Visual Analogue Scale (VAS), intraoperative and postoperative hemodynamic stability, sedation levels, quality of recovery assessed at 24 hours via the Quality of Recovery-15 (QoR-15) questionnaire, and the incidence of any adverse effects or block-related complications.

Official title: Safety and Efficacy of Dexamethasone Versus Dexmedetomidine as Adjuvants in Pericapsular Nerve Group (PENG) Block in Hip Surgeries for Postoperative Pain Management

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-10

Completion Date

2027-11

Last Updated

2026-09-29

Healthy Volunteers

No

Interventions

DRUG

Bupivacaine 0.25%

Plain bupivacaine 0.25% (20 mL) administered perineurally via ultrasound-guided Pericapsular Nerve Group (PENG) block, along with plain bupivacaine 0.25% (5 mL) for Lateral Femoral Cutaneous Nerve (LFCN) block without adjuvant.

DRUG

Dexamethasone

Perineural dexamethasone 4 mg combined with bupivacaine 0.25% to an identical total volume of 20 mL, administered via ultrasound-guided Pericapsular Nerve Group (PENG) block, along with plain bupivacaine 0.25% (5 mL) for LFCN block.

DRUG

Dexmedetomidine

Perineural dexmedetomidine 1 µg/kg combined with bupivacaine 0.25% to an identical total volume of 20 mL, administered via ultrasound-guided Pericapsular Nerve Group (PENG) block, along with plain bupivacaine 0.25% (5 mL) for LFCN block.