- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07445009
Comparison of Pericapsular Nerve Group+ Lateral Femoral Cutaneous Nerve Block Versus Lumbar Erector Spinae Plane Block in Hip Arthroplasty Surgery
Evaluation of The Effect of Ultrasound Guided Regional Blocks on Postoperative Analgesia in Hip Arthroplasty Using The Quality of Recovery-15 (QoR-15) Scale
Hip replacement surgery (partial or total hip arthroplasty) is commonly performed in elderly patients and is associated with significant postoperative pain. Effective pain management is critical to support early mobilization, reduce complications, shorten hospital stay, and prevent postoperative delirium.This observational study evaluates the effect of two ultrasound-guided regional analgesia approaches on postoperative pain and recovery quality in patients aged 65 years and older undergoing hip arthroplasty under general anesthesia:
Group 1: Pericapsular Nerve Group (PENG) block + Lateral Femoral Cutaneous Nerve (LFCN) block Group 2: PENG block + Lumbar Erector Spinae Plane (ESP) block Both techniques are applied as part of routine clinical practice at our institution. The primary outcome is quality of recovery assessed by the QoR-15 questionnaire at 24 hours after surgery. Secondary outcomes include postoperative opioid consumption, pain scores (NRS), incidence of postoperative delirium (NU-DESC), nausea and vomiting, and time to mobilization. Patients are also followed up by telephone at postoperative day 7 and day 30 for mortality and morbidity assessment.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Design This is a prospective, observational, single-center study conducted at Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Turkey. Patients were allocated to one of two regional analgesia groups based on clinical decision-making by the anesthesia team according to surgical type, patient positioning, and clinician experience, consistent with the routine clinical practice of the institution.
Patient Population Patients aged ≥65 years, ASA physical status I-III, scheduled for elective partial or total hip arthroplasty under general anesthesia were enrolled. Patients with a Mini-Mental State Examination (MMSE) score below 24 were excluded. Written informed consent was obtained the day before surgery.
Anesthesia Protocol All patients received standardized general anesthesia: induction with propofol 2 mg/kg IV, fentanyl 2 mcg/kg IV, and rocuronium 0.6 mg/kg IV; maintenance with sevoflurane 1.5-2% and remifentanil 0.05-0.5 mcg/kg/min infusion, titrated to BIS 40-60. Standard monitoring included ECG, non-invasive blood pressure, SpO2, temperature, and BIS. Normothermia was maintained with active forced-air warming. All patients received paracetamol 1 g IV, tramadol 1 mg/kg IV, and ondansetron 4 mg IV 20 minutes before the end of surgery.
Regional Analgesia Techniques
At the end of surgery, under ultrasound guidance:
PENG block: 20 ml of 0.25% bupivacaine injected into the musculofascial plane anterior to the psoas tendon and posterior to the pubic ramus LFCN block: 5 ml of 0.25% bupivacaine injected around the lateral femoral cutaneous nerve between the tensor fascia latae and sartorius muscles Lumbar ESP block: 20 ml of 0.25% bupivacaine injected at the anterior fascia of the erector spinae muscle at the L4 transverse process level Postoperative Management Patient-controlled analgesia (PCA) with tramadol (10 mg bolus, 20-minute lockout) was initiated in the recovery unit. Dexketoprofen 50 mg IV was administered as rescue analgesia if NRS ≥4 within the first 20 minutes. Paracetamol 1 g IV every 6 hours was continued on the ward. Ondansetron 4 mg IV (and dexamethasone 4 mg IV if needed) was used for postoperative nausea and vomiting management.
Outcome Measures
Primary outcome:
QoR-15 score at 24 hours postoperatively compared with the baseline preoperative score.
Secondary outcomes:
NRS pain scores (at rest and on movement) at 0, 15, and 30 minutes in the PACU and at 2, 4, 6, 12, and 24 hours on the ward; total tramadol consumption; time to first rescue analgesic; postoperative nausea and vomiting scores; NU-DESC delirium screening; sedation assessment; hemodynamic parameters; and 7- and 30-day mortality and morbidity assessed by telephone follow-up.
Sample Size Sample size calculation was performed based on previously published QoR-15 data. With an effect size of 0.729, 80% power, and a 95% confidence level, a minimum of 31 patients per group (62 total) was required. The analysis was conducted using G*Power version 3.1.9.7.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey (Türkiye), 34000
- Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 65 years or older
- ASA physical status I-III
- Scheduled for elective partial or total hip arthroplasty under general anesthesia
- Mini-Mental State Examination (MMSE) score ≥24
- Written informed consent obtained
Exclusion Criteria:
- MMSE score below 24
- Refusal to participate
- Known allergy to local anesthetics or study medications
- Coagulation disorders or anticoagulant use contraindicating regional block
- Infection at the block site
- Pre-existing chronic pain conditions requiring opioid therapy
- ASA physical status IV or above
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
PENG + LFCN Block
Patients who received ultrasound-guided Pericapsular Nerve Group (PENG) block (20 ml 0.25% bupivacaine) combined with Lateral Femoral Cutaneous Nerve (LFCN) block (5 ml 0.25% bupivacaine) at the end of surgery for postoperative analgesia.
|
Ultrasound-guided Pericapsular Nerve Group (PENG) block with 20 ml 0.25% bupivacaine combined with Lateral Femoral Cutaneous Nerve (LFCN) block with 5 ml 0.25% bupivacaine, applied at the end of surgery.
|
|
PENG + ESP Block
Patients who received ultrasound-guided Pericapsular Nerve Group (PENG) block (20 ml 0.25% bupivacaine) combined with Lumbar Erector Spinae Plane (ESP) block (20 ml 0.25% bupivacaine) at the end of surgery for postoperative analgesia.
|
Ultrasound-guided Pericapsular Nerve Group (PENG) block with 20 ml 0.25% bupivacaine combined with Lumbar Erector Spinae Plane (ESP) block with 20 ml 0.25% bupivacaine, applied at the end of surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Recovery (QoR-15 Score)
Time Frame: 24 hours after surgery
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Quality of postoperative recovery assessed using the 15-item Quality of Recovery scale (QoR-15).
Scores range from 0 to 150, with higher scores indicating better recovery quality.
Scores are categorized as excellent (>135), good (122-135), moderate (90-121), or poor (<90).
Baseline (preoperative) and postoperative 24-hour scores are compared between groups.
|
24 hours after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Score at Rest
Time Frame: At 0, 15, 30 minutes in PACU and at 2, 4, 6, 12, 24 hours postoperatively
|
Pain intensity at rest assessed using the Numeric Rating Scale (NRS, 0-10; 0=no pain, 10=worst imaginable pain)
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At 0, 15, 30 minutes in PACU and at 2, 4, 6, 12, 24 hours postoperatively
|
|
Postoperative Pain Score on Movement
Time Frame: At 0, 15, 30 minutes in PACU and at 2, 4, 6, 12, 24 hours postoperatively
|
Pain intensity on movement assessed using the Numeric Rating Scale (NRS, 0-10; 0=no pain, 10=worst imaginable pain)
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At 0, 15, 30 minutes in PACU and at 2, 4, 6, 12, 24 hours postoperatively
|
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Total Tramadol Consumption
Time Frame: 24 hours after surgery
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Total amount of tramadol consumed via patient-controlled analgesia (PCA) in the first 24 hours postoperatively
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24 hours after surgery
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Time to First Rescue Analgesic
Time Frame: 24 hours after surgery
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Time from end of surgery to first administration of rescue analgesic (dexketoprofen 50 mg IV) due to NRS ≥4
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24 hours after surgery
|
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Postoperative Nausea and Vomiting (PONV)
Time Frame: At 2, 4, 6, 12, 24 hours postoperatively
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PONV severity assessed using a 5-point scale (0=no nausea, 1=mild nausea, 2=moderate nausea, 3=vomiting less than twice per hour, 4=vomiting more than twice per hour)
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At 2, 4, 6, 12, 24 hours postoperatively
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Postoperative Mortality and Morbidity
Time Frame: At postoperative day 7 and day 30
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Presence of mortality and morbidity assessed by telephone follow-up
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At postoperative day 7 and day 30
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Incidence of Postoperative Delirium
Time Frame: At 2, 4, 6, 12, 24 hours postoperatively
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Postoperative delirium assessed using the Nursing Delirium Screening Scale (NU-DESC).
The NU-DESC score ranges from 0 to 10, with each of the five items scored from 0 to 2. A total score ≥2 indicates the presence of delirium.
Higher scores indicate greater severity of delirium (worse outcome).
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At 2, 4, 6, 12, 24 hours postoperatively
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Collaborators and Investigators
Investigators
- Principal Investigator: eda eseroglu gulsen, MD, Fatih Sultan Mehmet Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Wounds and Injuries
- Postoperative Complications
- Pathologic Processes
- Leg Injuries
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Fractures, Bone
- Femoral Fractures
- Hip Injuries
- Delirium
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Emergence Delirium
- Pain, Postoperative
- Hip Fractures
Other Study ID Numbers
- FSMTRH-EDA-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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