Postoperative PainDSG-PENGNCT07770932
Deep Subgluteal Block vs PENG Combined With LFCN Block for Analgesia After Hip Arthroplasty
A study testing 0.25% Bupivacaine for Deep Subgluteal Block and 0.25% and 0.125% Bupivacaine for PENG+LFCN Block in people with Postoperative Pain, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- 0.25% Bupivacaine for Deep Subgluteal Block and 0.25% and 0.125% Bupivacaine for PENG+LFCN Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Infection, severe anatomic distortion, or previous surgery at the proposed block injection sites
- History of substance abuse or chronic opioid use (defined as daily opioid use for > 3 months prior to surgery)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Medipol Mega University Hospital
Istanbul, Bagcilar, 34214
Haci Ahmet Alici, MD, Prof., +90 212 453 4800, haalici@medipol.edu.tr
About this study
Official title: Comparison of Deep Subgluteal Block and Pericapsular Nerve Group Block Combined With Lateral Femoral Cutaneous Nerve Block for Postoperative Analgesia After Hip Arthroplasty: A Randomized Prospective Study
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).
Read the detailed description
This randomized, prospective, double-blind study is designed to evaluate and compare the postoperative analgesic efficacy of two different ultrasound-guided regional anesthesia techniques in patients undergoing elective hip arthroplasty under general anesthesia. Following institutional ethical approval and written informed consent, a total of 60 patients will be randomly allocated into two equal groups (n=30 per group): Group DSG (Deep Subgluteal Block) and Group PENG+LFCN (Pericapsular Nerve Group block combined with Lateral Femoral Cutaneous Nerve block).
To optimize methodological quality, minimize bias, and maintain a strict double-blind design, both total local anesthetic volume (30 mL) and total active drug dose (75 mg bupivacaine) are perfectly standardized between the groups. All regional blocks will be performed by an experienced anesthesiologist using a high-frequency ultrasound transducer under sterile conditions after surgery is completed but before patient emergence/extubation.
In Group DSG (n=30), patients will receive a total of 30 mL of 0.25% bupivacaine (15 mL administered beneath the gluteus minimus muscle and 15 mL beneath the gluteus medius muscle). No saline will be added to this group.
In Group PENG+LFCN (n=30), patients will receive a total injection volume of 30 mL divided into two separate targets. First, the PENG block will be performed with 20 mL of 0.25% bupivacaine. Second, the LFCN block will be performed using a 10 mL volume consisting of 5 mL of 0.25% bupivacaine diluted with 5 mL of normal saline (0.9% NaCl), resulting in a final local anesthetic concentration of 0.125% bupivacaine at the LFCN site.
Following block administration, a standard general anesthesia protocol will be applied. Postoperative patient-controlled analgesia (PCA) with intravenous fentanyl (10 mcg/mL solution, 10 mcg bolus, 10-minute lockout time, no basal infusion) will be initiated in the post-anesthesia care unit (PACU). Multi-modal analgesia will be supplemented with scheduled oral/IV ibuprofen (400 mg every 8 hours) and tramadol administered 30 minutes before the end of surgery.
Postoperative pain assessments will be performed by a blinded independent investigator at 0 (PACU), 2, 4, 8, 16, and 24 hours using the Numerical Rating Scale (NRS) both at rest and during movement. In case of severe pain (NRS >= 4), intravenous meperidine (0.5 mg/kg) will be administered as rescue analgesia. Cumulative opioid consumption, quadriceps motor strength (evaluated via the Oxford Muscle Strength Scale), and opioid-related adverse effects (such as postoperative nausea, vomiting, or pruritus) will be comprehensively monitored and recorded for the first 24 hours.
- Conditions
- Postoperative Pain
- Being tested
- 0.25% Bupivacaine for Deep Subgluteal Block, 0.25% and 0.125% Bupivacaine for PENG+LFCN Block
- Keywords
- Deep Subgluteal Block PENG Block Lateral Femoral Cutaneous Nerve Block Hip Arthroplasty Nerve Block Opioid Consumption
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.25% Bupivacaine for Deep Subgluteal BlockDrug
Ultrasound-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 BlockDrug
Ultrasound-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).
| Study group | Role | What they receive |
|---|---|---|
| Group DSG | Active comparator | Patients will receive an ultrasound-guided Deep Subgluteal Block using a total of 30 mL of 0.25% bupivacaine (15 mL administered beneath the gluteus minimus muscle and 15 mL beneath the gluteus medius muscle). Receives: Drug: 0.25% Bupivacaine for Deep Subgluteal Block |
| Group PENG+LCFN | Active comparator | Patients will receive an ultrasound-guided Pericapsular Nerve Group (PENG) block combined with a Lateral Femoral Cutaneous Nerve (LFCN) block. The PENG block will be performed with 20 mL of 0.25% bupivacaine. The LFCN block will be performed using a 10 mL volume consisting of 5 mL of 0.25% bupivacaine diluted with 5 mL of normal saline (0.9% NaCl), resulting in a final local anesthetic concentration of 0.125% bupivacaine at the LFCN site. Receives: Drug: 0.25% and 0.125% Bupivacaine for PENG+LFCN Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Postoperative Opioid Consumption
Total intravenous fentanyl consumption (in micrograms) delivered via patient-controlled analgesia (PCA) within the first 24 hours postoperatively.
Measured: First 24 hours postoperatively
Secondary outcomes (3)
Postoperative Pain Scores
Pain intensity evaluated at rest and during movement using the Numerical Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain).
Measured: Postoperative hours 0 (PACU), 2, 4, 8, 16, and 24
Quadriceps Motor Strength
Assessment of quadriceps motor block evaluated using the Oxford Muscle Strength Scale (0 = total paralysis, 5 = normal strength).
Measured: Postoperative hours 2, 4, 8, 16, and 24
Opioid-Related Adverse Effects
Incidence of opioid-related side effects including postoperative nausea, vomiting, pruritus, and respiratory depression.
Measured: First 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomly assigned to one of the two parallel groups to receive either ultrasound-guided Deep Subgluteal Block or a combination of PENG and LFCN blocks.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunus Oktay Atalay, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770932
- Sponsor's protocol ID
- E-10840098-772.02-2965
- Acronym
- DSG-PENG
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Deep Subgluteal Block and Pericapsular Nerve Group Block Combined With Lateral Femoral Cutaneous Nerve Block for Postoperative Analgesia After Hip Arthroplasty: A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT07770932
- Acronym / sponsor ID
- DSG-PENG / E-10840098-772.02-2965
- Conditions
- Postoperative Pain
- Keywords
- Deep Subgluteal Block PENG Block Lateral Femoral Cutaneous Nerve Block Hip Arthroplasty Nerve Block Opioid Consumption
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 18 Aug 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.
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).
Detailed description
This randomized, prospective, double-blind study is designed to evaluate and compare the postoperative analgesic efficacy of two different ultrasound-guided regional anesthesia techniques in patients undergoing elective hip arthroplasty under general anesthesia. Following institutional ethical approval and written informed consent, a total of 60 patients will be randomly allocated into two equal groups (n=30 per group): Group DSG (Deep Subgluteal Block) and Group PENG+LFCN (Pericapsular Nerve Group block combined with Lateral Femoral Cutaneous Nerve block).
To optimize methodological quality, minimize bias, and maintain a strict double-blind design, both total local anesthetic volume (30 mL) and total active drug dose (75 mg bupivacaine) are perfectly standardized between the groups. All regional blocks will be performed by an experienced anesthesiologist using a high-frequency ultrasound transducer under sterile conditions after surgery is completed but before patient emergence/extubation.
In Group DSG (n=30), patients will receive a total of 30 mL of 0.25% bupivacaine (15 mL administered beneath the gluteus minimus muscle and 15 mL beneath the gluteus medius muscle). No saline will be added to this group.
In Group PENG+LFCN (n=30), patients will receive a total injection volume of 30 mL divided into two separate targets. First, the PENG block will be performed with 20 mL of 0.25% bupivacaine. Second, the LFCN block will be performed using a 10 mL volume consisting of 5 mL of 0.25% bupivacaine diluted with 5 mL of normal saline (0.9% NaCl), resulting in a final local anesthetic concentration of 0.125% bupivacaine at the LFCN site.
Following block administration, a standard general anesthesia protocol will be applied. Postoperative patient-controlled analgesia (PCA) with intravenous fentanyl (10 mcg/mL solution, 10 mcg bolus, 10-minute lockout time, no basal infusion) will be initiated in the post-anesthesia care unit (PACU). Multi-modal analgesia will be supplemented with scheduled oral/IV ibuprofen (400 mg every 8 hours) and tramadol administered 30 minutes before the end of surgery.
Postoperative pain assessments will be performed by a blinded independent investigator at 0 (PACU), 2, 4, 8, 16, and 24 hours using the Numerical Rating Scale (NRS) both at rest and during movement. In case of severe pain (NRS >= 4), intravenous meperidine (0.5 mg/kg) will be administered as rescue analgesia. Cumulative opioid consumption, quadriceps motor strength (evaluated via the Oxford Muscle Strength Scale), and opioid-related adverse effects (such as postoperative nausea, vomiting, or pruritus) will be comprehensively monitored and recorded for the first 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are randomly assigned to one of the two parallel groups to receive either ultrasound-guided Deep Subgluteal Block or a combination of PENG and LFCN blocks.
| Arm | Type | Receives |
|---|---|---|
| Group DSG | Active comparator | Drug: 0.25% Bupivacaine for Deep Subgluteal BlockPatients will receive an ultrasound-guided Deep Subgluteal Block using a total of 30 mL of 0.25% bupivacaine (15 mL administered beneath the gluteus minimus muscle and 15 mL beneath the gluteus medius muscle). |
| Group PENG+LCFN | Active comparator | Drug: 0.25% and 0.125% Bupivacaine for PENG+LFCN BlockPatients will receive an ultrasound-guided Pericapsular Nerve Group (PENG) block combined with a Lateral Femoral Cutaneous Nerve (LFCN) block. The PENG block will be performed with 20 mL of 0.25% bupivacaine. The LFCN block will be performed using a 10 mL volume consisting of 5 mL of 0.25% bupivacaine diluted with 5 mL of normal saline (0.9% NaCl), resulting in a final local anesthetic concentration of 0.125% bupivacaine at the LFCN site. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
- Infection, severe anatomic distortion, or previous surgery at the proposed block injection sites
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 |
|---|---|---|
| 0.25% Bupivacaine for Deep Subgluteal BlockUltrasound-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. | Drug | Group DSG |
| 0.25% and 0.125% Bupivacaine for PENG+LFCN BlockUltrasound-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). | Drug | Group PENG+LCFN |
Primary outcome
Cumulative Postoperative Opioid Consumption
Time frame: First 24 hours postoperatively
Total intravenous fentanyl consumption (in micrograms) delivered via patient-controlled analgesia (PCA) within the first 24 hours postoperatively.
3 secondary outcomes
Postoperative Pain Scores
Time frame: Postoperative hours 0 (PACU), 2, 4, 8, 16, and 24
Quadriceps Motor Strength
Time frame: Postoperative hours 2, 4, 8, 16, and 24
Opioid-Related Adverse Effects
Time frame: First 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.25% Bupivacaine for Deep Subgluteal Block and 0.25% and 0.125% Bupivacaine for PENG+LFCN Block in people with Postoperative Pain, run by Medipol University 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 18 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunus O Atalay, MD, Prof., DESAIC (+90 212 453 4800, yoatalay@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Postoperative Opioid Consumption (time frame: First 24 hours postoperatively). 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 18 Aug 2026; AzTrials last refreshed its copy on 1 Nov 2026.