An observational study in Hip Arthroplasty, Postoperative Pain and Hip Fractures, sponsored by Fatih Sultan Mehmet Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by Fatih Sultan Mehmet Training and Research Hospital · Observational
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 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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 62 is below the median of 102 across 608 observational studies indexed under Pain, Postoperative.
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Elderly patients (≥65 years) undergoing elective partial or total hip arthroplasty under general anesthesia at Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Turkey.
Exclusion Criteria:
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.
Procedure: PENG + LFCN 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.
Procedure: PENG + Lumbar ESP Block
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.
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.
Quality of Recovery (QoR-15 Score)
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.
Time frame: 24 hours after surgery
Postoperative Pain Score at Rest
Pain intensity at rest assessed using the Numeric Rating Scale (NRS, 0-10; 0=no pain, 10=worst imaginable pain)
Time frame: At 0, 15, 30 minutes in PACU and at 2, 4, 6, 12, 24 hours postoperatively
Postoperative Pain Score on Movement
Pain intensity on movement assessed using the Numeric Rating Scale (NRS, 0-10; 0=no pain, 10=worst imaginable pain)
Time frame: At 0, 15, 30 minutes in PACU and at 2, 4, 6, 12, 24 hours postoperatively
Total Tramadol Consumption
Total amount of tramadol consumed via patient-controlled analgesia (PCA) in the first 24 hours postoperatively
Time frame: 24 hours after surgery
Time to First Rescue Analgesic
Time from end of surgery to first administration of rescue analgesic (dexketoprofen 50 mg IV) due to NRS ≥4
Time frame: 24 hours after surgery
Incidence of Postoperative Delirium
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).
Time frame: At 2, 4, 6, 12, 24 hours postoperatively
Postoperative Nausea and Vomiting (PONV)
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)
Time frame: At 2, 4, 6, 12, 24 hours postoperatively
Postoperative Mortality and Morbidity
Presence of mortality and morbidity assessed by telephone follow-up
Time frame: At postoperative day 7 and day 30
Plan to share: No — Individual participant data will not be shared due to local ethical and institutional data privacy regulations. Patient confidentiality is protected in accordance with Turkish Personal Data Protection Law (KVKK). Aggregated and de-identified data supporting the findings of this study may be made available upon reasonable request to the corresponding author.
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Fatih Sultan Mehmet Training and Research Hospital