- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05921110
Evaluation of the Effectiviness of Two Different Bupivacaine Concentrations of the Pericapsular Nerve Group (PENG) Block (PENG)
Evaluation of the Effectiveness of Two Different Bupivacaine Concentrations of Ultrasound-guided Postoperative PENG Block in Hip Operations Performed With Spinal Anesthesia
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ilker Ital
- Phone Number: +905337723300
- Email: ilkerital@gmail.com
Study Contact Backup
- Name: Fatma Saridemir
- Phone Number: +905067179398
- Email: fatos_dtz2@hotmail.com
Study Locations
-
-
-
Bolu, Turkey, 14030
- Recruiting
- Bolu Abant İzzet Baysal University Faculty of Medicine
-
Sub-Investigator:
- Ilker Ital, MD
-
Contact:
- Ilker Ital, MD
- Phone Number: 05337723300
- Email: ilkerital@gmail.com
-
Sub-Investigator:
- Hamit Yoldas, MD
-
Sub-Investigator:
- Cengiz Isık, MD
-
Principal Investigator:
- Fatma Saridemir, MD
-
Bolu, Turkey, 14030
- Recruiting
- Bolu Abant İzzet Baysal Medical School
-
Contact:
- Ilker Ital, MD
- Phone Number: (0374) 253 46 56
- Email: ilkerital@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ASA I- III risk undergoing hip surgery.
Exclusion Criteria:
- Contraindications for regional blocks (eg. patient refusal, coagulopathy, infection at the injection site), allergic reaction to local anesthetics and other analgesics.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: PENG Block %0,25
PENG Block will be applied with 0.25% bupivacaine in 20 ml volume under ultrasound guidance.
|
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.
Other Names:
|
Active Comparator: PENG Block %0,16
PENG Block will be applied with 0.16% bupivacaine in 20 ml volume under ultrasound guidance.
|
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
Other Names:
|
No Intervention: Control Group
Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
First 24 Hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VAS ( Visual Analogue Scale) scores
Time Frame: 1th, 2nd, 4th, 8th,12th,18th and 24th hours
|
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').
|
1th, 2nd, 4th, 8th,12th,18th and 24th hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Fatma Saridemir, Bolu Abant İzzet Baysal Medical School
- Study Director: Hamit Yoldas, Bolu Abant İzzet Baysal Medical School
- Study Chair: Ilker Ital, Bolu Abant İzzet Baysal Medical School
- Study Chair: Cengiz Isık, Bolu Abant İzzet Baysal Medical School
Publications and helpful links
General Publications
- Giron-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.
- 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.
- Del 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.
- Guven 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-TF-AR-II-004
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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