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

September 23, 2026 updated by: Mohamed Esameldin Ghanem Ahmed, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group C (Control)

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%

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.
Experimental: Group DX (Dexamethasone)

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%

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.
Experimental: Group DM (Dexmedetomidine)

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%

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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Request for Rescue Analgesia (Hours)
Time Frame: Up to 24 hours postoperatively

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

September 23, 2026

First Submitted That Met QC Criteria

September 23, 2026

First Posted (Actual)

September 29, 2026

Study Record Updates

Last Update Posted (Actual)

September 29, 2026

Last Update Submitted That Met QC Criteria

September 23, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Adjuvants in Hip PENG Block

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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