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Evaluation of the Effectiviness of Two Different Bupivacaine Concentrations of the Pericapsular Nerve Group (PENG) Block (PENG)

Primary Purpose

Hip Fractures, Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pericapsular nerve group block 0,25%
Pericapsular nerve group block 0,16%
Sponsored by
Ilker Ital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring PENG Block, Hip Surgery, Postoperative Pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bolu Abant İzzet Baysal Medical SchoolRecruiting
  • Bolu Abant İzzet Baysal University Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

PENG Block %0,25

PENG Block %0,16

Control Group

Arm Description

PENG Block will be applied with 0.25% bupivacaine in 20 ml volume under ultrasound guidance.

PENG Block will be applied with 0.16% bupivacaine in 20 ml volume under ultrasound guidance.

Control

Outcomes

Primary Outcome Measures

Analgesic requirement
The amount of analgesic required in the first postoperative 24 hours is the primary outcome of this study.

Secondary Outcome Measures

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').

Full Information

First Posted
April 30, 2023
Last Updated
June 26, 2023
Sponsor
Ilker Ital
Collaborators
Abant Izzet Baysal University
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1. Study Identification

Unique Protocol Identification Number
NCT05921110
Brief Title
Evaluation of the Effectiviness of Two Different Bupivacaine Concentrations of the Pericapsular Nerve Group (PENG) Block
Acronym
PENG
Official Title
Evaluation of the Effectiveness of Two Different Bupivacaine Concentrations of Ultrasound-guided Postoperative PENG Block in Hip Operations Performed With Spinal Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ilker Ital
Collaborators
Abant Izzet Baysal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Postoperative Pain
Keywords
PENG Block, Hip Surgery, Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PENG Block %0,25
Arm Type
Active Comparator
Arm Description
PENG Block will be applied with 0.25% bupivacaine in 20 ml volume under ultrasound guidance.
Arm Title
PENG Block %0,16
Arm Type
Active Comparator
Arm Description
PENG Block will be applied with 0.16% bupivacaine in 20 ml volume under ultrasound guidance.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control
Intervention Type
Procedure
Intervention Name(s)
Pericapsular nerve group block 0,25%
Other Intervention Name(s)
PENG Block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Pericapsular nerve group block 0,16%
Other Intervention Name(s)
PENG Block
Intervention Description
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
Primary Outcome Measure Information:
Title
Analgesic requirement
Description
The amount of analgesic required in the first postoperative 24 hours is the primary outcome of this study.
Time Frame
First 24 Hour
Secondary Outcome Measure Information:
Title
VAS ( Visual Analogue Scale) scores
Description
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').
Time Frame
1th, 2nd, 4th, 8th,12th,18th and 24th hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilker Ital
Phone
+905337723300
Email
ilkerital@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma Saridemir
Phone
+905067179398
Email
fatos_dtz2@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatma Saridemir
Organizational Affiliation
Bolu Abant İzzet Baysal Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hamit Yoldas
Organizational Affiliation
Bolu Abant İzzet Baysal Medical School
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ilker Ital
Organizational Affiliation
Bolu Abant İzzet Baysal Medical School
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cengiz Isık
Organizational Affiliation
Bolu Abant İzzet Baysal Medical School
Official's Role
Study Chair
Facility Information:
Facility Name
Bolu Abant İzzet Baysal Medical School
City
Bolu
ZIP/Postal Code
14030
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilker Ital, MD
Phone
(0374) 253 46 56
Email
ilkerital@gmail.com
Facility Name
Bolu Abant İzzet Baysal University Faculty of Medicine
City
Bolu
ZIP/Postal Code
14030
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilker Ital, MD
Phone
05337723300
Email
ilkerital@gmail.com
First Name & Middle Initial & Last Name & Degree
Hamit Yoldas, MD
First Name & Middle Initial & Last Name & Degree
Cengiz Isık, MD
First Name & Middle Initial & Last Name & Degree
Fatma Saridemir, MD
First Name & Middle Initial & Last Name & Degree
Ilker Ital, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
33269617
Citation
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.
Results Reference
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PubMed Identifier
34428334
Citation
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.
Results Reference
background
PubMed Identifier
33432791
Citation
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.
Results Reference
background
PubMed Identifier
30063657
Citation
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.
Results Reference
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Learn more about this trial

Evaluation of the Effectiviness of Two Different Bupivacaine Concentrations of the Pericapsular Nerve Group (PENG) Block

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