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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 to 60 years.

American Society of Anesthesiologists (ASA) physical status class I or II.

Scheduled for elective unilateral total hip replacement under spinal anesthesia.

Disqualifiers

Patient refusal of the peripheral nerve block.

Infection at the site of injection.

Coagulopathy or contraindication to spinal anesthesia.

Known allergy or hypersensitivity to any of the study medications.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bupivacaine 0.25%

    Drug

    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.

  • Dexamethasone

    Drug

    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.

  • Dexmedetomidine

    Drug

    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.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Group C (Control)Active comparator 1 intervention
Group B: Group DX (Dexamethasone)Experimental treatment 2 interventions
Group C: Group DM (Dexmedetomidine)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Time to First Request for Rescue Analgesia (Hours)

Duration of postoperative analgesia in hours, measured from the completion of the nerve block to the patient's first request for rescue analgesia (intravenous morphine PCA triggered for VAS score of 3 or greater). If a patient does not request analgesia within the observation period, data will be censored at 24 hours.

Time frame
Up to 24 hours postoperatively

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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