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Comparison of the Effects of Pericapsular Nerve Group (PENG), Suprainguinal Fascia Iliaca Compartment (S-FICB) and 3-1 Blocks on Comfort in Positioning for Unilateral Spinal Anesthesia and Postoperative Pain in Hip Fracture Surgery

Primary Purpose

Hip Fractures, Pain Management, Pain Postoperative

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pericapsular Nerve Group Block
Suprainguinal Fascia Compartment Block
3-1 Block
Sponsored by
Bozyaka Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring Hip Fracture, Unilateral Spinal Anesthesia, Pericapsular Nerve Group Block, 3-1 Block, Suprainguinal Fascia Iliaca Compartment Block, Pain Management

Eligibility Criteria

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

Inclusion Criteria: 18 years and over American Society of Anesthesiologists Physical Status Classification(ASA) I,II and III Fully oriented and able to cooperate Consented to participate in the study by signing the informed consent form Patients with hip fracture and planned unilateral surgery with spinal anesthesia Exclusion Criteria: Patients under 18 years of age Refusal to participate American Society of Anesthesiologists Physical Status Classification(ASA) IV-V Non-cooperation Coagulopathy or thrombocytopenia Allergic to local anesthetics and analgesics Patients with anatomical abnormalities or active infection at the points of application

Sites / Locations

  • Izmir Bozyaka Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1 (PENG)

Group 2 (S-FICB)

Group 3 (3-1)

Arm Description

A convex USG Probe (1-5 mHz) is placed transversely on the SIAS (Spina Iliaca Anterior Superior). The probe is then rotated 45 degrees and aligned with the pubic ramus. In this position, the iliopubic eminence, ilipsoas muscle-tendon, femoral artery and pectineus muscle are observed. A 100 mm 21G block needle (Stimuplex A®:B. Braun Melsungen AG, Japan) is inserted in-plane from lateral to medial to the musculofascial plane with the psoas tendon in front and the pubic ramus behind and the injection is performed.

A linear USG probe (7-13 mHz) is placed parasagittal to obtain an image of the SIAS. The probe is then shifted medially to identify the fascia iliaca, iliac muscle, internal oblique muscle and deep circumflex iliac artery. A 50 mm 21G block needle (Stimuplex A®:B. Braun Melsungen AG, Japan) is advanced in-plane from caudal to cephalic and injected between the fascia iliaca and iliac muscle.

A linear USG probe (7-13 mHz) is placed at the level of the femoral fold and the femoral vein-arterial-nerve is visualized. The femoral nerve is located below the fascia iliaca. At this point, a 50 mm 21G block needle (Stimuplex A®:B. Braun Melsungen AG, Japan) is inserted in-plane from lateral to medial and injected lateral to the femoral nerve. After injection, pressure is applied distal to the needle entry site to spread the local anesthetic proximally in the nerve sheath.

Outcomes

Primary Outcome Measures

Positional Pain in Unilateral Spinal Anesthesia
Pain in the pre-block period and during unilateral spinal anesthesia positioning after the block will be evaluated by VAS score.

Secondary Outcome Measures

Position Quality in Unilateral Spinal Anesthesia
The quality of the patient position will be assessed by Anesthesiologist B who administers spinal anesthesia and is blind to the blocks performed (0 = insufficient, 1 = sufficient, 2 = good, 3 = optimal)
The Necessity for Sedoanalgesia for Positional Pain in Unilateral Spinal Anesthesia
The necessity for sedoanalgesia for pain in the unilateral spinal anesthesia position will be assessed by the Anesthesiologist B who administers spinal anesthesia and is blind to the blocks performed. Rescue sedoanalgesia (propofol - ketamine combination) will be applied to patients with VAS >3. Patients will be recorded as 1 = needing sedoanalgesia, 2 = not needing sedoanalgesia.
Postoperative Pain
Postoperative pain at 2nd, 6th, 12th and 24th hours will be evaluated using VAS by Anesthesiologist B who is blind to the blocks performed.
The Time Until First Opiod Requirement
Within the first 24-hour-period, as soon as the VAS >3, intravenous opiod (1 mg/kg Tramadol) will be administered and time to first opioid requirement will be recorded.
Postoperative First 24-hour-period Total Opioid Consumption
Total opioid (tramadol) consumption in the first 24 hours postoperatively will be recorded in mg/kg/day.
Patient and Surgeon Satisfaction
Patient and surgeon satisfaction will be evaluated as: 1 = Complete dissatisfaction, 2 = Moderate dissatisfaction, 3 = Moderate satisfaction, 4 = Complete satisfaction
Undesirable Side Effects
Recorded when there is vascular puncture, hematoma, signs of LA toxicity.

Full Information

First Posted
June 11, 2023
Last Updated
June 11, 2023
Sponsor
Bozyaka Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05912101
Brief Title
Comparison of the Effects of Pericapsular Nerve Group (PENG), Suprainguinal Fascia Iliaca Compartment (S-FICB) and 3-1 Blocks on Comfort in Positioning for Unilateral Spinal Anesthesia and Postoperative Pain in Hip Fracture Surgery
Official Title
Comparison of the Effects of Pericapsular Nerve Group (PENG), Suprainguinal Fascia Iliaca Compartment (S-FICB) and 3-1 Blocks on Comfort in Positioning for Unilateral Spinal Anesthesia and Postoperative Pain in Hip Fracture Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bozyaka Training and Research Hospital

4. Oversight

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

5. Study Description

Brief Summary
Hip fracture is a common cause of surgery, especially in elderly patients. Unilateral spinal anesthesia in hip fracture surgery can prevent the undesirable effects of spinal anesthesia due to sympathetic blockade. However, severe pain in hip fracture patients limits the positioning required for unilateral spinal anesthesia. The sedation and analgesia required to position patients with fractured hip remains inferior may cause respiratory depression, hemodynamic instability or postoperative cognitive impairment, especially in elderly patients. Lower extremity peripheral blocks can be used preoperatively to minimize the use of sedatives that may be required during positioning and to provide effective and safe analgesia.
Detailed Description
In the study, one anesthesiologist (Anesthesiologist A) will perform the relevant peripheral blocks according to the groups to which the patients are randomized; the other anesthesiologist (Anesthesiologist B) will perform unilateral spinal anesthesia in all patients blinded to the peripheral blocks. On the day of surgery, the patients will first be taken to the block application room and standard monitoring (ECG, pulse oximetry, noninvasive blood pressure) will be applied in the supine position. In the pre-block period, individual pain assessment will be performed with the Visual Analog Scale (VAS - 0 cm = no pain / 10 cm = unbearable pain) and recorded on the case report form. After the pain assessment, disinfection of the block area will be performed with 10% povidone iodine (Batidex) in accordance with surgical sterilization rules. After sterilization, the relevant peripheral block will be performed by Anesthesiologist A under USG guidance. Intermittent negative aspiration will be performed during all interventions to detect possible vascular puncture. All groups will receive 30 ml of local anesthetic solution containing 5 mcg/ml adrenaline and bupivacaine at 0.25% concentration. Group 1 (PENG Block): Convex USG Probe (1-5 mHz) is placed transversely on SIAS (Spina Iliaca Anterior Superior). The probe is then rotated 45 degrees and aligned with the pubic ramus. In this position, the iliopubic eminence, ilipsoas muscle-tendon, femoral artery and pectineus muscle are observed. A 100 mm 21G block needle (Stimuplex A®:B. Braun Melsungen AG, Japan) is inserted in-plane from lateral to medial to the musculofascial plane with the psoas tendon in front and the pubic ramus behind and the injection is performed. Group 2 (Suprainguinal Fascia Iliaca Compartment Block) : Linear USG Probe (7-13 mHz) is placed parasagittal to obtain an image of the SIAS. The probe is then shifted medially to identify the fascia iliaca, iliac muscle, internal oblique muscle and deep circumflex iliac artery. A 50 mm 21G block needle (Stimuplex A®:B. Braun Melsungen AG, Japan) is advanced in-plane from caudal to cephalic and injected between the fascia iliaca and iliac muscle. Group 3 (3-1 Block) Linear USG Probe (7-13 mHz) is placed at the femoral fold and femoral vein-arterial-nerve is visualized. The femoral nerve is located below the fascia iliaca. At this point, a 50 mm 21G block needle (Stimuplex A®:B. Braun Melsungen AG, Japan) is inserted in-plane from lateral to medial and injected lateral to the femoral nerve. After injection, pressure is applied distal to the needle entry site to spread the local anesthetic proximally in the nerve sheath. The VAS score of the patients will be reevaluated and recorded during positioning for unilateral spinal anesthesia 30 minutes after the block is performed. Patients with VAS > 3 will be administered sedoanalgesia with propofol - ketamine combination as rescue analgesia before spinal anesthesia and recorded in the case report form. (1 = need sedoanalgesia / 2 = no need sedoanalgesia) Unilateral spinal anesthesia will be administered by Anesthesiologist B after the patient is positioned so that the fractured hip remains at the bottom. The quality of the patient's position will be evaluated by Anesthesiologist B administering spinal anesthesia and recorded on the case report form (0 = inadequate, 1 = adequate, 2 = good, 3 = optimal) All patients will be routinely administered 1000 mg acetominophen 3x1 in the postoperative period. All patients will be followed up in terms of VAS score and possible opioid requirement in the postoperative 24 hours and evaluated in terms of satisfaction with the procedure. Patients will be monitored for 24 hours in terms of undesirable side effects and if signs of vascular puncture, hematoma, LA toxicity are observed, these events will be recorded in the case report form and serious adverse reactions will be reported.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Pain Management, Pain Postoperative, Spinal Anesthesia, Nerve Block/Methods
Keywords
Hip Fracture, Unilateral Spinal Anesthesia, Pericapsular Nerve Group Block, 3-1 Block, Suprainguinal Fascia Iliaca Compartment Block, Pain Management

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group 1 (PENG)
Arm Type
Experimental
Arm Description
A convex USG Probe (1-5 mHz) is placed transversely on the SIAS (Spina Iliaca Anterior Superior). The probe is then rotated 45 degrees and aligned with the pubic ramus. In this position, the iliopubic eminence, ilipsoas muscle-tendon, femoral artery and pectineus muscle are observed. A 100 mm 21G block needle (Stimuplex A®:B. Braun Melsungen AG, Japan) is inserted in-plane from lateral to medial to the musculofascial plane with the psoas tendon in front and the pubic ramus behind and the injection is performed.
Arm Title
Group 2 (S-FICB)
Arm Type
Experimental
Arm Description
A linear USG probe (7-13 mHz) is placed parasagittal to obtain an image of the SIAS. The probe is then shifted medially to identify the fascia iliaca, iliac muscle, internal oblique muscle and deep circumflex iliac artery. A 50 mm 21G block needle (Stimuplex A®:B. Braun Melsungen AG, Japan) is advanced in-plane from caudal to cephalic and injected between the fascia iliaca and iliac muscle.
Arm Title
Group 3 (3-1)
Arm Type
Experimental
Arm Description
A linear USG probe (7-13 mHz) is placed at the level of the femoral fold and the femoral vein-arterial-nerve is visualized. The femoral nerve is located below the fascia iliaca. At this point, a 50 mm 21G block needle (Stimuplex A®:B. Braun Melsungen AG, Japan) is inserted in-plane from lateral to medial and injected lateral to the femoral nerve. After injection, pressure is applied distal to the needle entry site to spread the local anesthetic proximally in the nerve sheath.
Intervention Type
Procedure
Intervention Name(s)
Pericapsular Nerve Group Block
Intervention Description
A convex USG Probe (1-5 mHz) is placed transversely on the SIAS (Spina Iliaca Anterior Superior). The probe is then rotated 45 degrees and aligned with the pubic ramus. In this position, the iliopubic eminence, ilipsoas muscle-tendon, femoral artery and pectineus muscle are observed. A 100 mm 21G block needle (Stimuplex A®:B. Braun Melsungen AG, Japan) is inserted in-plane from lateral to medial to the musculofascial plane with the psoas tendon in front and the pubic ramus behind and the injection is performed.
Intervention Type
Procedure
Intervention Name(s)
Suprainguinal Fascia Compartment Block
Intervention Description
A linear USG probe (7-13 mHz) is placed parasagittal to obtain an image of the SIAS. The probe is then shifted medially to identify the fascia iliaca, iliac muscle, internal oblique muscle and deep circumflex iliac artery. A 50 mm 21G block needle (Stimuplex A®:B. Braun Melsungen AG, Japan) is advanced in-plane from caudal to cephalic and injected between the fascia iliaca and iliac muscle.
Intervention Type
Procedure
Intervention Name(s)
3-1 Block
Intervention Description
A linear USG probe (7-13 mHz) is placed at the level of the femoral fold and the femoral vein-arterial-nerve is visualized. The femoral nerve is located below the fascia iliaca. At this point, a 50 mm 21G block needle (Stimuplex A®:B. Braun Melsungen AG, Japan) is inserted in-plane from lateral to medial and injected lateral to the femoral nerve. After injection, pressure is applied distal to the needle entry site to spread the local anesthetic proximally in the nerve sheath.
Primary Outcome Measure Information:
Title
Positional Pain in Unilateral Spinal Anesthesia
Description
Pain in the pre-block period and during unilateral spinal anesthesia positioning after the block will be evaluated by VAS score.
Time Frame
30 minutes after the block is performed
Secondary Outcome Measure Information:
Title
Position Quality in Unilateral Spinal Anesthesia
Description
The quality of the patient position will be assessed by Anesthesiologist B who administers spinal anesthesia and is blind to the blocks performed (0 = insufficient, 1 = sufficient, 2 = good, 3 = optimal)
Time Frame
30 minutes after the block is performed
Title
The Necessity for Sedoanalgesia for Positional Pain in Unilateral Spinal Anesthesia
Description
The necessity for sedoanalgesia for pain in the unilateral spinal anesthesia position will be assessed by the Anesthesiologist B who administers spinal anesthesia and is blind to the blocks performed. Rescue sedoanalgesia (propofol - ketamine combination) will be applied to patients with VAS >3. Patients will be recorded as 1 = needing sedoanalgesia, 2 = not needing sedoanalgesia.
Time Frame
30 minutes after the block is performed
Title
Postoperative Pain
Description
Postoperative pain at 2nd, 6th, 12th and 24th hours will be evaluated using VAS by Anesthesiologist B who is blind to the blocks performed.
Time Frame
Postoperative 2nd, 6th, 12th and 24th hours
Title
The Time Until First Opiod Requirement
Description
Within the first 24-hour-period, as soon as the VAS >3, intravenous opiod (1 mg/kg Tramadol) will be administered and time to first opioid requirement will be recorded.
Time Frame
Postoperative first 24-hour-period
Title
Postoperative First 24-hour-period Total Opioid Consumption
Description
Total opioid (tramadol) consumption in the first 24 hours postoperatively will be recorded in mg/kg/day.
Time Frame
Postoperative first 24-hour-period
Title
Patient and Surgeon Satisfaction
Description
Patient and surgeon satisfaction will be evaluated as: 1 = Complete dissatisfaction, 2 = Moderate dissatisfaction, 3 = Moderate satisfaction, 4 = Complete satisfaction
Time Frame
Immediately after the surgery
Title
Undesirable Side Effects
Description
Recorded when there is vascular puncture, hematoma, signs of LA toxicity.
Time Frame
Postoperative first 24-hour-period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years and over American Society of Anesthesiologists Physical Status Classification(ASA) I,II and III Fully oriented and able to cooperate Consented to participate in the study by signing the informed consent form Patients with hip fracture and planned unilateral surgery with spinal anesthesia Exclusion Criteria: Patients under 18 years of age Refusal to participate American Society of Anesthesiologists Physical Status Classification(ASA) IV-V Non-cooperation Coagulopathy or thrombocytopenia Allergic to local anesthetics and analgesics Patients with anatomical abnormalities or active infection at the points of application
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nuri Arda Ertem, MD
Phone
+90 232 250 50 50
Email
n.ardaertem@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zeki Tuncel Tekgul, Professor, MD
Phone
+90 232 250 50 50
Email
zekittekgul@yahoo.com
Facility Information:
Facility Name
Izmir Bozyaka Training and Research Hospital
City
Izmir
State/Province
Karabaglar
ZIP/Postal Code
35170
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nuri Arda Ertem, MD
Phone
+90 0232 250 50 50
Email
n.ardaertem@gmail.com
First Name & Middle Initial & Last Name & Degree
Nuri Arda Ertem, MD
First Name & Middle Initial & Last Name & Degree
Zeki Tuncel Tekgul, Professor, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
background
PubMed Identifier
21401544
Citation
Hebbard P, Ivanusic J, Sha S. Ultrasound-guided supra-inguinal fascia iliaca block: a cadaveric evaluation of a novel approach. Anaesthesia. 2011 Apr;66(4):300-5. doi: 10.1111/j.1365-2044.2011.06628.x. Epub 2011 Feb 24.
Results Reference
background
PubMed Identifier
4796576
Citation
Winnie AP, Ramamurthy S, Durrani Z. The inguinal paravascular technic of lumbar plexus anesthesia: the "3-in-1 block". Anesth Analg. 1973 Nov-Dec;52(6):989-96. No abstract available.
Results Reference
background

Learn more about this trial

Comparison of the Effects of Pericapsular Nerve Group (PENG), Suprainguinal Fascia Iliaca Compartment (S-FICB) and 3-1 Blocks on Comfort in Positioning for Unilateral Spinal Anesthesia and Postoperative Pain in Hip Fracture Surgery

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