Hip FracturesPENGNCT05921110
Evaluation of the Effectiviness of Two Different Bupivacaine Concentrations of the Pericapsular Nerve Group (PENG) Block
A study testing Pericapsular nerve group block 0,25% and Pericapsular nerve group block 0,16% in people with Hip Fractures and Postoperative Pain, run by Ilker Ital at 2 sites in Turkey (Türkiye).
Trial summary
The use of regional anaesthesia techniques as part of multimodal analgesia in hip surgeries improves postoperative analgesia. PENG (Pericapsular nerve group) block is an effective motor sparing analgesia technique used in hip surgeries. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hip Fractures, Postoperative Pain
- What is being tested?
- Pericapsular nerve group block 0,25% and Pericapsular nerve group block 0,16%
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 May 2023to 30 Nov 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I- III risk undergoing hip surgery.
Who cannot join
- Contraindications for regional blocks (eg. patient refusal, coagulopathy, infection at the injection site), allergic reaction to local anesthetics and other analgesics.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Bolu Abant İzzet Baysal Medical School
Bolu, 14030
Ilker Ital, MD, (0374) 253 46 56, ilkerital@gmail.com
- Recruiting
Bolu Abant İzzet Baysal University Faculty of Medicine
Bolu, 14030
Ilker Ital, MD, 05337723300, ilkerital@gmail.com
Hamit Yoldas, MD
About this study
Official title: Evaluation of the Effectiveness of Two Different Bupivacaine Concentrations of Ultrasound-guided Postoperative PENG Block in Hip Operations Performed With Spinal Anesthesia
The use of regional anaesthesia techniques as part of multimodal analgesia in hip surgeries improves postoperative analgesia. PENG (Pericapsular nerve group) block is an effective motor sparing analgesia technique used in hip surgeries. The purpose of this study was to assess the efficacy of PENG block in terms of analgesic requirements and pain density in patients undergoing hip surgery, using two different concentrations of local anaesthetic.
Read the detailed description
Hip operations; it is applied in femur fractures adjacent to the hip joint or in pathologies requiring reconstruction. It is operated with general anesthesia or neuraxial anesthetic blocking methods. Patients who are planned to heal bone and regain function with prosthesis after these operations are faced with acute pain due to surgical incisions and traumas in the postoperative period.
Pharmacological treatment comes to the fore in pain management in patients who are admitted to the service after surgery. Today, multimodal pain treatment is recommended for postoperative analgesia, and regional analgesia is a very important part of this. Despite their side effects, opioids are frequently used in patients with postoperative pain. In patients who will undergo hip surgery, apart from pharmacological methods; methods such as neuraxial blocks (spinal anesthesia, epidural anesthesia) are used. Alternatively, peripheral nerve blocks such as femoral nerve, sciatic nerve, lumbar plexus block, 3 in 1 block acting on this area are applied. With the increase in the use of ultrasound (US), the number and success of analgesic and anesthetic nerve blocks have increased. Especially US guided field blocks (such as erector spinae block, suprainguinal fascia iliaca block, pericapsular nerve group (PENG) block...) have become an important part of multimodal analgesia. As the advantages of these blocks made with US; technique is simple, its application is practical and it is safe in terms of complications. PENG block applied with US is one of the new methods; local anesthetic drugs are injected into the fascia, which is the transition region of the articular branches that receive the sensation of the hip joint.
The aim of this study is to evaluate the analgesia levels of patients undergoing hip surgery by applying two different doses of PENG block after surgery. Sixtysix patients with ASA I-III risk, aged between 18-85 years, who were planned for elective hip surgery under spinal anesthesia at Bolu AIBU Medical Faculty Hospital will be included in the study. The patients will be randomly divided into 3 groups (Group 0.25, Group 0.16, Group C (Control)) randomized, prospective, using the randomizer.org website. Patients will be informed about the study during the preoperative evaluation and information will be given about the visual analog pain scale (VAS) and Patient controlled analgesia (PCA) device to be used for postoperative analgesia. Both verbal and written consent will be obtained. After being taken to the operating table, standard monitoring will be performed by opening a vascular access to all patients. Anesthesia will be provided by spinal anesthesia from neuraxial blocks. A total of 12.5-15 mg with a 25-27 G spinal needle from the L3-4 vertebral space to the patient. (2.5-3 ml. volume) Heavy Bupivacaine 0.5% will be injected into the subarachnoid area and the success of the block will be checked and the surgical procedure will be started. Ultrasound-guided PENG block will be applied to patients with postoperative PENG block at doses of 2,5 mg/ml and 1,6mg/ml in 20 ml volumes on the side of the operated hip, depending on their groups. In the control group, only standard analgesic procedures will be applied. In the patients to be treated, asepsis-antisepsis will be applied in the supine position and the anterior inferior iliac process and iliopubic eminence, tendon of the iliopsoas muscle will be visualized using the convex ultrasound probe (Esaote MyLab 5). After the hydrodissection is made with 2 ml of physiological saline, it will be seen that there is no air or blood with the help aspiration. Local anesthetic solution will be applied and its distribution will be monitored. No postoperative block procedure will be applied to the patients in Group C.
Postoperative intravenous (iv) PCA will be applied to patients in all three groups. For this, Tramadol HCL (Tramosel 100 mg/2 ml Haver Pharma İlaç A.Ş, Istanbul) continuous opioid infusion at 4mg/ml concentration is 2 ml/hour, at a maximum dose of 400mg within 24 hours, with a 20-minute locking interval and bolus doses of 20 mg tramadol HCL will be administered iv each time the patient presses button. Paracetamol 3x1000 mg iv will be applied. Before the operation, the patient will be told to press the button whenever he has pain. VAS values at the 1st, 2nd, 4th, 8th, 12th, 18th, 24th hours after the operation, SAP (Systolic arterial pressure), DAP (Distolic arterial pressure), MAP (Mean arterial pressure), HR (Heart pulse rate), SpO2 (Peripheral oxygen saturation), opioid consumption (tramadol HCL ) at the 0-1, 1-12, 12-24 hours, and patient satisfaction level before discharge, whether there is motor loss or not will be registered. If nausea, vomiting, pruritus, allergy, desaturation, and other side effects occur in the patient follow-up, they will be recorded. Nausea, vomiting will be treated with ondansetron iv, rash and pruritus will be treated with feniramin hidrojen maleat iv. When analgesia is insufficient, 75 mg diclofenac sodium intramuscular (im) as a rescue analgesic when VAS is above 4 was planned.
- Conditions
- Hip Fractures, Postoperative Pain
- Being tested
- Pericapsular nerve group block 0,25%, Pericapsular nerve group block 0,16%
- Keywords
- PENG Block, Hip Surgery, Postoperative Pain
- Medical subject headings
- Hip Fractures, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular nerve group block 0,25%Procedure or surgery
Also called PENG Block
Used for postoperative anagesia after hip operations under spinal anaesthesia.
Drug: Bupivacaine (Block Drug)
For block performances, 0,25% Bupivacaine will be used at 20 ml volume.
Pericapsular nerve group block 0,16%Procedure or surgery
Also called PENG Block
Used for postoperative anagesia after hip operations under spinal anaesthesia.
Drug: Bupivacaine (Block Drug)
For block performances, 0,16% Bupivacaine will be used at 20 ml volume
| Study group | Role | What they receive |
|---|---|---|
| PENG Block %0,25 | Active comparator | PENG Block will be applied with 0.25% bupivacaine in 20 ml volume under ultrasound guidance. Receives: Procedure: Pericapsular nerve group block 0,25% |
| PENG Block %0,16 | Active comparator | PENG Block will be applied with 0.16% bupivacaine in 20 ml volume under ultrasound guidance. Receives: Procedure: Pericapsular nerve group block 0,16% |
| Control Group | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic requirement
The amount of analgesic required in the first postoperative 24 hours is the primary outcome of this study.
Measured: First 24 Hour
Secondary outcomes (1)
VAS ( Visual Analogue Scale) scores
The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Measured: 1th, 2nd, 4th, 8th,12th,18th and 24th hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start15 May 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ilker Ital
- Sponsor type
- University, hospital or other
- Collaborators
- Abant Izzet Baysal University
- Responsible party
- Sponsor-investigator, Ilker Ital, Abant Izzet Baysal University
- Investigators
- Fatma Saridemir, Principal investigator, Bolu Abant İzzet Baysal Medical SchoolHamit Yoldas, Study director, Bolu Abant İzzet Baysal Medical SchoolIlker Ital, Study chair, Bolu Abant İzzet Baysal Medical SchoolCengiz Isık, Study chair, Bolu Abant İzzet Baysal Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921110
- Sponsor's protocol ID
- AIBU-TF-AR-II-004
- Acronym
- PENG
- Status last verified
- Jun 2023
- First submitted
- 30 Apr 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Remily EA, Hochstein SR, Wilkie WA, Mohamed NS, Thompson JV, Kluk MW, Nace J, Delanois RE. The pericapsular nerve group block: a step towards outpatient total hip arthroplasty? Hip Int. 2022 May;32(3):318-325. doi: 10.1177/1120700020978211. Epub 2020 Dec 3.
PubMed 33269617Guven Kose S, Kose HC, Arslan G, Eler Cevik B, Tulgar S. Evaluation of ultrasound-guided adductor canal block with two different concentration of bupivacaine in arthroscopic knee surgery: A feasibility study. Int J Clin Pract. 2021 Nov;75(11):e14747. doi: 10.1111/ijcp.14747. Epub 2021 Sep 3.
PubMed 34428334Del Buono R, Padua E, Pascarella G, Costa F, Tognu A, Terranova G, Greco F, Fajardo Perez M, Barbara E. Pericapsular nerve group block: an overview. Minerva Anestesiol. 2021 Apr;87(4):458-466. doi: 10.23736/S0375-9393.20.14798-9. Epub 2021 Jan 12.
PubMed 33432791Giron-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 30063657
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Two Different Bupivacaine Concentrations of Ultrasound-guided Postoperative PENG Block in Hip Operations Performed With Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT05921110
- Acronym / sponsor ID
- PENG / AIBU-TF-AR-II-004
- Conditions
- Hip Fractures, Postoperative Pain
- Keywords
- PENG Block, Hip Surgery, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Ilker ItalUniversity, hospital or other
- Collaborators
- Abant Izzet Baysal University
- Study start
- 15 May 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 27 Jun 2023 (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.
The use of regional anaesthesia techniques as part of multimodal analgesia in hip surgeries improves postoperative analgesia. PENG (Pericapsular nerve group) block is an effective motor sparing analgesia technique used in hip surgeries. The purpose of this study was to assess the efficacy of PENG block in terms of analgesic requirements and pain density in patients undergoing hip surgery, using two different concentrations of local anaesthetic.
Detailed description
Hip operations; it is applied in femur fractures adjacent to the hip joint or in pathologies requiring reconstruction. It is operated with general anesthesia or neuraxial anesthetic blocking methods. Patients who are planned to heal bone and regain function with prosthesis after these operations are faced with acute pain due to surgical incisions and traumas in the postoperative period.
Pharmacological treatment comes to the fore in pain management in patients who are admitted to the service after surgery. Today, multimodal pain treatment is recommended for postoperative analgesia, and regional analgesia is a very important part of this. Despite their side effects, opioids are frequently used in patients with postoperative pain. In patients who will undergo hip surgery, apart from pharmacological methods; methods such as neuraxial blocks (spinal anesthesia, epidural anesthesia) are used. Alternatively, peripheral nerve blocks such as femoral nerve, sciatic nerve, lumbar plexus block, 3 in 1 block acting on this area are applied. With the increase in the use of ultrasound (US), the number and success of analgesic and anesthetic nerve blocks have increased. Especially US guided field blocks (such as erector spinae block, suprainguinal fascia iliaca block, pericapsular nerve group (PENG) block...) have become an important part of multimodal analgesia. As the advantages of these blocks made with US; technique is simple, its application is practical and it is safe in terms of complications. PENG block applied with US is one of the new methods; local anesthetic drugs are injected into the fascia, which is the transition region of the articular branches that receive the sensation of the hip joint.
The aim of this study is to evaluate the analgesia levels of patients undergoing hip surgery by applying two different doses of PENG block after surgery. Sixtysix patients with ASA I-III risk, aged between 18-85 years, who were planned for elective hip surgery under spinal anesthesia at Bolu AIBU Medical Faculty Hospital will be included in the study. The patients will be randomly divided into 3 groups (Group 0.25, Group 0.16, Group C (Control)) randomized, prospective, using the randomizer.org website. Patients will be informed about the study during the preoperative evaluation and information will be given about the visual analog pain scale (VAS) and Patient controlled analgesia (PCA) device to be used for postoperative analgesia. Both verbal and written consent will be obtained. After being taken to the operating table, standard monitoring will be performed by opening a vascular access to all patients. Anesthesia will be provided by spinal anesthesia from neuraxial blocks. A total of 12.5-15 mg with a 25-27 G spinal needle from the L3-4 vertebral space to the patient. (2.5-3 ml. volume) Heavy Bupivacaine 0.5% will be injected into the subarachnoid area and the success of the block will be checked and the surgical procedure will be started. Ultrasound-guided PENG block will be applied to patients with postoperative PENG block at doses of 2,5 mg/ml and 1,6mg/ml in 20 ml volumes on the side of the operated hip, depending on their groups. In the control group, only standard analgesic procedures will be applied. In the patients to be treated, asepsis-antisepsis will be applied in the supine position and the anterior inferior iliac process and iliopubic eminence, tendon of the iliopsoas muscle will be visualized using the convex ultrasound probe (Esaote MyLab 5). After the hydrodissection is made with 2 ml of physiological saline, it will be seen that there is no air or blood with the help aspiration. Local anesthetic solution will be applied and its distribution will be monitored. No postoperative block procedure will be applied to the patients in Group C.
Postoperative intravenous (iv) PCA will be applied to patients in all three groups. For this, Tramadol HCL (Tramosel 100 mg/2 ml Haver Pharma İlaç A.Ş, Istanbul) continuous opioid infusion at 4mg/ml concentration is 2 ml/hour, at a maximum dose of 400mg within 24 hours, with a 20-minute locking interval and bolus doses of 20 mg tramadol HCL will be administered iv each time the patient presses button. Paracetamol 3x1000 mg iv will be applied. Before the operation, the patient will be told to press the button whenever he has pain. VAS values at the 1st, 2nd, 4th, 8th, 12th, 18th, 24th hours after the operation, SAP (Systolic arterial pressure), DAP (Distolic arterial pressure), MAP (Mean arterial pressure), HR (Heart pulse rate), SpO2 (Peripheral oxygen saturation), opioid consumption (tramadol HCL ) at the 0-1, 1-12, 12-24 hours, and patient satisfaction level before discharge, whether there is motor loss or not will be registered. If nausea, vomiting, pruritus, allergy, desaturation, and other side effects occur in the patient follow-up, they will be recorded. Nausea, vomiting will be treated with ondansetron iv, rash and pruritus will be treated with feniramin hidrojen maleat iv. When analgesia is insufficient, 75 mg diclofenac sodium intramuscular (im) as a rescue analgesic when VAS is above 4 was planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PENG Block %0,25 | Active comparator | Procedure: Pericapsular nerve group block 0,25%PENG Block will be applied with 0.25% bupivacaine in 20 ml volume under ultrasound guidance. |
| PENG Block %0,16 | Active comparator | Procedure: Pericapsular nerve group block 0,16%PENG Block will be applied with 0.16% bupivacaine in 20 ml volume under ultrasound guidance. |
| Control Group | No intervention | –Control |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I- III risk undergoing hip surgery.
Key exclusion criteria (1 listed)
- Contraindications for regional blocks (eg. patient refusal, coagulopathy, infection at the injection site), allergic reaction to local anesthetics and other analgesics.
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 |
|---|---|---|
| Pericapsular nerve group block 0,25%Also: PENG BlockUsed for postoperative anagesia after hip operations under spinal anaesthesia. Drug: Bupivacaine (Block Drug) For block performances, 0,25% Bupivacaine will be used at 20 ml volume. | Procedure or surgery | PENG Block %0,25 |
| Pericapsular nerve group block 0,16%Also: PENG BlockUsed for postoperative anagesia after hip operations under spinal anaesthesia. Drug: Bupivacaine (Block Drug) For block performances, 0,16% Bupivacaine will be used at 20 ml volume | Procedure or surgery | PENG Block %0,16 |
Primary outcome
Analgesic requirement
Time frame: First 24 Hour
The amount of analgesic required in the first postoperative 24 hours is the primary outcome of this study.
1 secondary outcome
VAS ( Visual Analogue Scale) scores
Time frame: 1th, 2nd, 4th, 8th,12th,18th and 24th hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Background: PubMed 33269617Remily EA, Hochstein SR, Wilkie WA, Mohamed NS, Thompson JV, Kluk MW, Nace J, Delanois RE. The pericapsular nerve group block: a step towards outpatient total hip arthroplasty? Hip Int. 2022 May;32(3):318-325. doi: 10.1177/1120700020978211. Epub 2020 Dec 3.
- Background: PubMed 34428334Guven Kose S, Kose HC, Arslan G, Eler Cevik B, Tulgar S. Evaluation of ultrasound-guided adductor canal block with two different concentration of bupivacaine in arthroscopic knee surgery: A feasibility study. Int J Clin Pract. 2021 Nov;75(11):e14747. doi: 10.1111/ijcp.14747. Epub 2021 Sep 3.
- Background: PubMed 33432791Del Buono R, Padua E, Pascarella G, Costa F, Tognu A, Terranova G, Greco F, Fajardo Perez M, Barbara E. Pericapsular nerve group block: an overview. Minerva Anestesiol. 2021 Apr;87(4):458-466. doi: 10.23736/S0375-9393.20.14798-9. Epub 2021 Jan 12.
- 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.
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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.
Fatma Saridemir principal investigator
Bolu Abant İzzet Baysal Medical School
Hamit Yoldas study director
Bolu Abant İzzet Baysal Medical School
Ilker Ital study chair
Bolu Abant İzzet Baysal Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pericapsular nerve group block 0,25% and Pericapsular nerve group block 0,16% in people with Hip Fractures and Postoperative Pain, run by Ilker Ital at 2 sites 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 1 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: status not confirmed, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilker Ital (+905337723300, ilkerital@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic requirement (time frame: First 24 Hour). 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 NCT05921110, which also lists 4 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 27 Jun 2023.