Hip ArthroplastyNCT07445009
Comparison of Pericapsular Nerve Group+ Lateral Femoral Cutaneous Nerve Block Versus Lumbar Erector Spinae Plane Block in Hip Arthroplasty Surgery
An observational study of Hip Arthroplasty and Postoperative Pain, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Arthroplasty, Postoperative Pain, Hip Fractures
- What is being tested?
- PENG + LFCN Block and PENG + Lumbar ESP Block
- Type of treatment
- Surgery or procedure
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients (≥65 years) undergoing elective partial or total hip arthroplasty under general anesthesia at Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Turkey.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital
Istanbul, 34000
About this study
Official title: 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.
Read the 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.
- Being tested
- PENG + LFCN Block, PENG + Lumbar ESP Block
- Keywords
- PENG block, Erector Spinae Plane Block, Lateral Femoral Cutaneous Nerve Block, Regional Analgesia, QoR-15, Quality of Recovery, Multimodal Analgesia, Hip Arthroplasty
- Medical subject headings
- Pain, Postoperative, Hip Fractures, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG + LFCN BlockProcedure or surgery
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 + Lumbar ESP BlockProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: PENG + LFCN Block | |
| 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. Receives: Procedure: PENG + Lumbar ESP Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours after surgery
Secondary outcomes (7)
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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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).
Measured: 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)
Measured: At 2, 4, 6, 12, 24 hours postoperatively
Postoperative Mortality and Morbidity
Presence of mortality and morbidity assessed by telephone follow-up
Measured: At postoperative day 7 and day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Jul 2024
- Primary completion1 Sep 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- eda eseroglu gulsen, MD, Principal investigator, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445009
- Sponsor's protocol ID
- FSMTRH-EDA-01
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Effect of Ultrasound Guided Regional Blocks on Postoperative Analgesia in Hip Arthroplasty Using The Quality of Recovery-15 (QoR-15) Scale
- ClinicalTrials.gov ID
- NCT07445009
- Acronym / sponsor ID
- FSMTRH-EDA-01
- Keywords
- PENG block, Erector Spinae Plane Block, Lateral Femoral Cutaneous Nerve Block, Regional Analgesia, QoR-15, Quality of Recovery, Multimodal Analgesia, Hip Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENG + LFCN Block | – | Procedure: PENG + LFCN BlockPatients 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. |
| PENG + ESP Block | – | Procedure: PENG + Lumbar ESP BlockPatients 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients (≥65 years) undergoing elective partial or total hip arthroplasty under general anesthesia at Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Turkey.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PENG + LFCN BlockUltrasound-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. | Procedure or surgery | PENG + LFCN Block |
| PENG + Lumbar ESP BlockUltrasound-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. | Procedure or surgery | PENG + ESP Block |
Primary outcome
Quality of Recovery (QoR-15 Score)
Time frame: 24 hours after surgery
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.
7 secondary outcomes
Postoperative Pain Score at Rest
Time frame: 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
Total Tramadol Consumption
Time frame: 24 hours after surgery
Time to First Rescue Analgesic
Time frame: 24 hours after surgery
Incidence of Postoperative Delirium
Time frame: At 2, 4, 6, 12, 24 hours postoperatively
Postoperative Nausea and Vomiting (PONV)
Time frame: At 2, 4, 6, 12, 24 hours postoperatively
Postoperative Mortality and Morbidity
Time frame: At postoperative day 7 and day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
eda eseroglu gulsen, MD principal investigator
Fatih Sultan Mehmet Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Arthroplasty and Postoperative Pain, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery (QoR-15 Score) (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.