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

NCT07847047 | Not Yet Recruiting Phase 3

• 1 other identifier: Adjuvants in Hip PENG Block
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Postoperative Pain; Total Hip Arthroplasty (THA)

Keywords

PENG block; Pericapsular nerve group block; Lateral femoral cutaneous nerve block; Dexamethasone; Dexmedetomidine; Bupivacaine; Regional anesthesia; Postoperative analgesia

Outcome Measures

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.

  Up to 24 hours postoperatively

Study Arms (3)

Group C (Control)

ACTIVE COMPARATOR

Participants receive an ultrasound-guided Pericapsular Nerve Group (PENG) block using 20 mL of plain bupivacaine 0.25% alone, followed by a lateral femoral cutaneous nerve (LFCN) block using 5 mL of plain bupivacaine 0.25% without adjuvant.

Drug: Bupivacaine 0.25%

Group DX (Dexamethasone)

EXPERIMENTAL

Participants receive an ultrasound-guided Pericapsular Nerve Group (PENG) block using bupivacaine 0.25% with dexamethasone 4 mg added (total volume 20 mL), followed by an LFCN block using 5 mL of plain bupivacaine 0.25% without adjuvant.

Drug: Bupivacaine 0.25%; Drug: Dexamethasone

Group DM (Dexmedetomidine)

EXPERIMENTAL

Participants receive an ultrasound-guided Pericapsular Nerve Group (PENG) block using bupivacaine 0.25% with dexmedetomidine 1 µg/kg added (total volume 20 mL), followed by an LFCN block using 5 mL of plain bupivacaine 0.25% without adjuvant.

Drug: Bupivacaine 0.25%; Drug: Dexmedetomidine

Interventions

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.

Group C (Control); Group DM (Dexmedetomidine); Group DX (Dexamethasone)

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.

Group DX (Dexamethasone)

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.

Group DM (Dexmedetomidine)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Baseline bradycardia or significant cardiac conduction abnormality.
• Chronic opioid use or pre-existing chronic pain on regular analgesics.
• Patients unable to communicate or reliably express pain scores.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone; Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 29, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09