Deep Subgluteal Block vs PENG Combined With LFCN Block for Analgesia After Hip Arthroplasty
ConditionPostoperative Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMedipol University
About this trial
This randomized, prospective study aims to compare the clinical efficacy of ultrasound-guided Deep Subgluteal Block (DSGB) versus Pericapsular Nerve Group (PENG) block combined with Lateral Femoral Cutaneous Nerve (LFCN) block for postoperative analgesia management in patients undergoing hip arthroplasty.
A total of 60 patients scheduled for hip arthroplasty under general anesthesia will be randomly allocated into two equal groups of 30: Group DSG and Group PENG+LFCN. Total local anesthetic volume (30 mL) and active drug dose (75 mg bupivacaine) will be standardized across both groups to ensure rigorous blinding and high methodological quality.
The primary outcome of the study is to compare total postoperative opioid (fentanyl) consumption within the first 24 hours. Secondary outcomes include postoperative pain scores evaluated via the Numerical Rating Scale (NRS) at rest and during movement, the presence and degree of quadriceps motor block, and opioid-related adverse effects (e.g., nausea, vomiting, pruritus).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients scheduled for elective total or partial hip arthroplasty under general anesthesia
American Society of Anesthesiologists (ASA) physical status I-III
Aged between 18 and 80 years
Able to understand the study procedures, give voluntary written informed consent, and operate a patient-controlled analgesia (PCA) device
Disqualifiers
Patient refusal or inability to provide informed consent
Pre-existing peripheral neuropathy, cognitive impairment, or psychiatric disorders
History of significant severe renal or hepatic failure
Allergy or hypersensitivity to amide-type local anesthetics or opioids
Trial design
Design model
Parallel
Treatments tested in this trial
0.25% Bupivacaine for Deep Subgluteal Block
DrugUltrasound-guided regional anesthesia. Patients receive 30 mL of 0.25% bupivacaine, divided as 15 mL beneath the gluteus minimus muscle and 15 mL beneath the gluteus medius muscle.
0.25% and 0.125% Bupivacaine for PENG+LFCN Block
DrugUltrasound-guided combination regional anesthesia. Patients receive a PENG block with 20 mL of 0.25% bupivacaine, combined with an LFCN block using 10 mL of 0.125% bupivacaine (5 mL of 0.25% bupivacaine diluted with 5 mL of 0.9% normal saline).
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Group DSGActive comparator 1 intervention
Group B: Group PENG+LCFNActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cumulative Postoperative Opioid Consumption
Total intravenous fentanyl consumption (in micrograms) delivered via patient-controlled analgesia (PCA) within the first 24 hours postoperatively.
Time frame
First 24 hours postoperativelySecondary outcomes
1
Postoperative Pain Scores
Pain intensity evaluated at rest and during movement using the Numerical Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain).
Time frame
Postoperative hours 0 (PACU), 2, 4, 8, 16, and 242
Quadriceps Motor Strength
Assessment of quadriceps motor block evaluated using the Oxford Muscle Strength Scale (0 = total paralysis, 5 = normal strength).
Time frame
Postoperative hours 2, 4, 8, 16, and 243
Opioid-Related Adverse Effects
Incidence of opioid-related side effects including postoperative nausea, vomiting, pruritus, and respiratory depression.
Time frame
First 24 hours postoperativelySponsors and contacts
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Source ClinicalTrials.gov