Total Hip SurgeryNCT05654519
Comparison of Pericapsular Nerve Group Block and Quadratus Lumborum Block
A study testing PENG/LFCN and QL Blocks in people with Total Hip Surgery and Pericapsular Nerve, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
Trial summary
Adequate pain management following total hip arthroplasty (THA) is a key component for patient satisfaction and early ambulation. However, due to the complexity of the innervation of the hip joint, the most appropriate anaesthetic and analgesic technique for THA remains unclear. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Total Hip Surgery, Pericapsular Nerve, Quadratus Lumborum
- What is being tested?
- PENG/LFCN and QL Blocks
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 21 Apr 2023
- Phase
- Interventional
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physical status according to American Society of Anesthesiologists (ASA ) I-III
Who cannot join
- Younger than 40 years old and older than 85
- Patients undergoing general anesthesia
- Allergy or intolerance to one of the study medications
- Infection of the skin at the site of the needle puncture,
- Patients who do not accept the procedure
- History of bleeding diathesis
Show all 11Show fewer
- ASA IV,
- Chronic gabapentin/pregabalin,opioid use
- Hepatic or renal insufficiency
- Previous operation on the same hip
- BMI >40
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Pericapsular Nerve Group Block with Lateral Femoral Cutaneous Nerve Block and Quadratus Lumborum Block for Total Hip Arthroplasty
Adequate pain management following total hip arthroplasty (THA) is a key component for patient satisfaction and early ambulation. However, due to the complexity of the innervation of the hip joint, the most appropriate anaesthetic and analgesic technique for THA remains unclear. A femoral nerve block is commonly performed and well established but is associated with motor weakness. Recently, the pericapsular nerve group (PENG) block has been introduced as an effective choice which targets the articular branches of the hip. The quadratus lumborum block (QLB) is a relatively new regional block that has been reported to provide effective analgesia for THA.
The main objective of this study is to compare the effectiveness of the ultrasound-guided PENG block technique compared to QLB block in terms of efficacy of pain control and the safety profile after total hip arthroplasty under spinal anesthesia.
Read the detailed description
The patients will be randomly classified into two equal groups (40 patients each). Group allocation will be done by computer generated random numbers and closed opaque sealed envelopes. The study will be designed to be double blind as all patients and outcomes assessor will be blinded to group assignment.
Patients will be randomized to one of three equal groups:
Group I (n= 40 patients): Patients in this group will receive an ipsilateral single shot of QLB (30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.
Group II(n= 40 patients): patients in this group will receive an ipsilateral single-shot of PENG block (25 ml of plain bupivacaine 0.25%) and LFCN block (5 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.
- Conditions
- Total Hip Surgery, Pericapsular Nerve, Quadratus Lumborum
- Being tested
- PENG/LFCN and QL Blocks
- Keywords
- Total Hip Surgery, PENG block, QLB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG/LFCN and QL BlocksDrug
Bupivacaine 0.25% injection
| Study group | Role | What they receive |
|---|---|---|
| Group QL Block | Active comparator | A convex transducer will be placed in the transverse plane on the flank cranial to the iliac crest to visualise the transverse process of the 4th lumbar vertebra, erector spina, quadratus lumborum and psoas muscles as a 'Shamrock sign'. The needle will inserted in to the fascial plane between the quadratus lumborum and psoas muscles and 30 ml bupivacaine 0.25% will be administered. Receives: Drug: PENG/LFCN and QL Blocks |
| Group PENG+LFCN Block | Active comparator | A linear probe will be placed on the anterior inferior iliac crest in the transverse plane while the patient is in the supine position. After rotating 45 degrees, the pubic ramus, femoral artery and psoas muscle will be visualized. Puncture will be performed in a lateromedial direction until the needle tip reached the plane between the iliopsoas tendon and the iliopubic eminence After a negative aspiration test, 25 ml bupivacaine 0.25% will be injected.
Then, the lateral femoral cutaneous nerve (LFCN) block was performed using linear US probe (10-18 MHz).The LFCN will be localized, infero-medially to the antero-superior iliac spine, laterally to the sartorius muscle and 5 ml of bupivacaine 0.25% will be carefully injected. Receives: Drug: PENG/LFCN and QL Blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
Numerical Rating Scale-NRS (0 = no pain and 10 = worst imaginable painranged from 0 to 10)
Measured: Changes from baseline opioid consumption at postoperative 0, 2, 6, 12 and 24 hours
Opioid consumption
Mean opioid consumption in morphine equivalents
Measured: Changes from baseline opioid consumption at postoperative 0, 2, 6, 12 and 24 hours
Secondary outcomes (3)
Quadriceps muscle strength
Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively
Measured: Postoperative 24 hours period
Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression
Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depressio
Measured: Postoperative 24 hours period
Patient satisfaction
Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No
Measured: Postoperative 24 hours period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start1 Jan 2022
- Primary completion10 Apr 2023
- Study completion21 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Total Hip SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Necmettin Erbakan Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper Kilicaslan, Konya Necmettin Erbakan Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654519
- Sponsor's protocol ID
- 2021-541
- Status last verified
- Apr 2023
- First submitted
- 30 Nov 2022
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hussain N, Brull R, Speer J, Hu LQ, Sawyer T, McCartney CJL, Abdallah FW. Analgesic benefits of the quadratus lumborum block in total hip arthroplasty: a systematic review and meta-analysis. Anaesthesia. 2022 Oct;77(10):1152-1162. doi: 10.1111/anae.15823. Epub 2022 Aug 10.
PubMed 35947882Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
PubMed 30063657Aslan M, Kilicaslan A, Gok F, Kekec AF, Colak TS. Comparison of pericapsular nerve group block and anterior quadratus lumborum block for hip fracture surgery: a randomized clinical trial. Braz J Anesthesiol. 2025 Sep-Oct;75(5):844643. doi: 10.1016/j.bjane.2025.844643. Epub 2025 May 23.
PubMed 40414494
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pericapsular Nerve Group Block with Lateral Femoral Cutaneous Nerve Block and Quadratus Lumborum Block for Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT05654519
- Acronym / sponsor ID
- 2021-541
- Conditions
- Total Hip Surgery, Pericapsular Nerve, Quadratus Lumborum
- Keywords
- Total Hip Surgery, PENG block, QLB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Konya Necmettin Erbakan ÜniversitesiUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 21 Apr 2023 (actual)
- First posted
- 16 Dec 2022 (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.
Adequate pain management following total hip arthroplasty (THA) is a key component for patient satisfaction and early ambulation. However, due to the complexity of the innervation of the hip joint, the most appropriate anaesthetic and analgesic technique for THA remains unclear. A femoral nerve block is commonly performed and well established but is associated with motor weakness. Recently, the pericapsular nerve group (PENG) block has been introduced as an effective choice which targets the articular branches of the hip. The quadratus lumborum block (QLB) is a relatively new regional block that has been reported to provide effective analgesia for THA.
The main objective of this study is to compare the effectiveness of the ultrasound-guided PENG block technique compared to QLB block in terms of efficacy of pain control and the safety profile after total hip arthroplasty under spinal anesthesia.
Detailed description
The patients will be randomly classified into two equal groups (40 patients each). Group allocation will be done by computer generated random numbers and closed opaque sealed envelopes. The study will be designed to be double blind as all patients and outcomes assessor will be blinded to group assignment.
Patients will be randomized to one of three equal groups:
Group I (n= 40 patients): Patients in this group will receive an ipsilateral single shot of QLB (30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.
Group II(n= 40 patients): patients in this group will receive an ipsilateral single-shot of PENG block (25 ml of plain bupivacaine 0.25%) and LFCN block (5 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Group QL Block | Active comparator | Drug: PENG/LFCN and QL BlocksA convex transducer will be placed in the transverse plane on the flank cranial to the iliac crest to visualise the transverse process of the 4th lumbar vertebra, erector spina, quadratus lumborum and psoas muscles as a 'Shamrock sign'. The needle will inserted in to the fascial plane between the quadratus lumborum and psoas muscles and 30 ml bupivacaine 0.25% will be administered. |
| Group PENG+LFCN Block | Active comparator | Drug: PENG/LFCN and QL BlocksA linear probe will be placed on the anterior inferior iliac crest in the transverse plane while the patient is in the supine position. After rotating 45 degrees, the pubic ramus, femoral artery and psoas muscle will be visualized. Puncture will be performed in a lateromedial direction until the needle tip reached the plane between the iliopsoas tendon and the iliopubic eminence After a negative aspiration test, 25 ml bupivacaine 0.25% will be injected. Then, the lateral femoral cutaneous nerve (LFCN) block was performed using linear US probe (10-18 MHz).The LFCN will be localized, infero-medially to the antero-superior iliac spine, laterally to the sartorius muscle and 5 ml of bupivacaine 0.25% will be carefully injected. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Physical status according to American Society of Anesthesiologists (ASA ) I-III
Key exclusion criteria (11 listed)
- Younger than 40 years old and older than 85
- Patients undergoing general anesthesia
- Allergy or intolerance to one of the study medications
- Infection of the skin at the site of the needle puncture,
- Patients who do not accept the procedure
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 and QL BlocksBupivacaine 0.25% injection | Drug | Group PENG+LFCN Block, Group QL Block |
Primary outcome
Pain scores
Time frame: Changes from baseline opioid consumption at postoperative 0, 2, 6, 12 and 24 hours
Numerical Rating Scale-NRS (0 = no pain and 10 = worst imaginable painranged from 0 to 10)
Opioid consumption
Time frame: Changes from baseline opioid consumption at postoperative 0, 2, 6, 12 and 24 hours
Mean opioid consumption in morphine equivalents
3 secondary outcomes
Quadriceps muscle strength
Time frame: Postoperative 24 hours period
Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression
Time frame: Postoperative 24 hours period
Patient satisfaction
Time frame: Postoperative 24 hours period
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 20 Dec 2024.
- Background: PubMed 35947882Hussain N, Brull R, Speer J, Hu LQ, Sawyer T, McCartney CJL, Abdallah FW. Analgesic benefits of the quadratus lumborum block in total hip arthroplasty: a systematic review and meta-analysis. Anaesthesia. 2022 Oct;77(10):1152-1162. doi: 10.1111/anae.15823. Epub 2022 Aug 10.
- Background: PubMed 30063657Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
- Derived from this study: PubMed 40414494Aslan M, Kilicaslan A, Gok F, Kekec AF, Colak TS. Comparison of pericapsular nerve group block and anterior quadratus lumborum block for hip fracture surgery: a randomized clinical trial. Braz J Anesthesiol. 2025 Sep-Oct;75(5):844643. doi: 10.1016/j.bjane.2025.844643. Epub 2025 May 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PENG/LFCN and QL Blocks in people with Total Hip Surgery and Pericapsular Nerve, run by Konya Necmettin Erbakan Üniversitesi 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 1 inclusion and 11 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 20 Dec 2024. 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?
Pain scores (time frame: Changes from baseline opioid consumption at postoperative 0, 2, 6, 12 and 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05654519, which also lists 3 linked publications.
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 20 Dec 2024.