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Comparing The Effectiveness Of Pericapsular Nerve Group (PENG) Block Versus Supra-Inguinal Fascia Iliaca Compartment Block(S-FICB) In Reducing Positional Pain During Neuraxial Anaesthesia In Hip Fractures Patients

Primary Purpose

Hip Fractures

Status
Recruiting
Phase
Phase 4
Locations
Malaysia
Study Type
Interventional
Intervention
Pericapsular nerve group (PENG) block
Supra-inguinal fascia iliaca compartment (S-FICB) block
Sponsored by
National University of Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring Hip Fractures Patients Going For Internal Fixation

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ASA I, II and III Hip fractures such as neck of femur (not older than 2 weeks and have persistent pain) Exclusion Criteria: Patients contraindicated to peripheral nerve blocks Patients with history of chronic pain Patients with significant cognitive impairment Patients with known allergic to study medications

Sites / Locations

  • Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan MalaysiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pericapsular nerve group (PENG) block

Supra-inguinal fascia iliaca compartment (S-FICB) block

Arm Description

The pericapsular nerve group (PENG) block is an ultrasound-guided approach, first described by Giron-Arango et al. for the blockade of the articular branches of the femoral, obturator and accessory obturator nerves that provide sensory innervation to the anterior hip capsule.

A supra-inguinal fascia iliaca compartment block (S-FICB), a 3 in 1 block involving femoral nerve , lateral femoral cutaneous nerve and obturator nerve.

Outcomes

Primary Outcome Measures

Pain score
Baseline pain scores (PS0) at rest and on movement (15° passive elevation) as PS0m will be recorded in the data collection sheet before PENG block or S-FICB administration and recorded on numeric pain rating scale (NRS).Pain score will be assessed via numerical pain rating scale (NRS) which the scale is composed of 0 (no pain at all; the best scoring) to 10 (worst imaginable pain; the worst scoring). The pain score will be categorised into mild pain (score of 1-4); moderate pain (score of 5-7) and severe pain (score of 8-10). Pain score will be assessed at 30 minute post bock during rest (PSPB) and on movement at 15° passive elevation (PSPBm). Pain score during positioning during neuraxial anaesthesia also will be recorded.

Secondary Outcome Measures

Ease of positioning during neuraxial anaesthesia
The ease of positioning will be graded by the attending anaesthetist with the scale of 0-3 (0 = unable to position, 1= patient has abnormal posturing due to pain and require support for positioning, 2= mild discomfort but does not require support for positioning, 3=optimal condition where the patient is able to position himself/ herself without pain)(The highest the score; the better the positional scoring)
Patient satisfaction toward the block being given
Post neuraxial anaesthesia the patients will be rated for satisfaction score via Likert scale for the block been given.(The higher the score; the better satisfaction toward the intervention)

Full Information

First Posted
January 26, 2023
Last Updated
February 8, 2023
Sponsor
National University of Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT05721924
Brief Title
Comparing The Effectiveness Of Pericapsular Nerve Group (PENG) Block Versus Supra-Inguinal Fascia Iliaca Compartment Block(S-FICB) In Reducing Positional Pain During Neuraxial Anaesthesia In Hip Fractures Patients
Official Title
Comparing The Effectiveness Of Pericapsular Nerve Group (PENG) Block Versus Supra-Inguinal Fascia Iliaca Compartment Block(S-FICB) In Reducing Positional Pain During Neuraxial Anaesthesia In Hip Fractures Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University of Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Fractures in and around the hip are common in the elderly and most of them required early surgical fixation. Hip fractures are accompanied with a considerable amount of pain. Based on National Orthopaedic Registry Malaysia (NORM), spinal/neuraxial anaesthesia makes up 66.3%, is the preferred mode of anaesthesia. Severe pain associated with fractured hip often results in difficulty during positioning for neuraxial anaesthesia and hence it is extremely challenging to position the patients in sitting or lateral position for neuraxial anaesthesia procedures. A supra-inguinal fascia iliaca compartment block (S-FICB), a 3 in 1 block involving femoral nerve , lateral femoral cutaneous nerve and obturator nerve. It is famous technique among anaesthesiologist to treat immediate and postoperative pain in hip fractures patients. The pericapsular nerve group (PENG) block is an ultrasound-guided approach, first described by Giron-Arango et al. in 2018 for the blockade of the articular branches of the femoral, obturator and accessory obturator nerves that provide sensory innervation to the anterior hip capsule. It is an alternative regional anaesthesia technique for the management of acute pain after hip fracture. The goal of this clinical trial is to compare the effectiveness of (PENG) block vs (S-FICB) block in reducing positional pain during neuraxial block in patients going for elective internal fixation of neck of femur fractures. And investigators's hypothesis is PENG block is as effective as S-FICB in reducing positional pain during neuraxial block in patients going for elective internal fixation of neck of femur fractures.
Detailed Description
The recruited participants will be randomly divided into two groups via stratified randomization based on participants's neck of femur fractures classification. Intra-articular fractures involving fractures within the hip joint. While extra-articular fractures are those fractures outside the capsule of the hip joint which are intertrochanteric and subtrochanteric. Two envelopes will be prepared which is intra-articular and extra-articular fractures envelope. In each envelope, there will be 10 "A" blocks and 10 "B" blocks. Researcher will draw from the particular envelope and thus Group A will be receiving PENG Block 30mls of 0.2% ropivacaine; Group B where the S-FICB will be given 30mls of 0.2% ropivacaine which will be prepared by researcher. The demographic data of the participants which include age, gender, height, weight, body mass index (BMI), ASA status, diagnosis and type of surgery will be recorded in the data collection sheet. Standard monitoring devices will be applied to all paricipants such as automatic non-invasive blood pressure (NIBP), electrocardiograph (ECG), and pulse oximetry (SPO2) will be recorded at baseline. Baseline pain scores (PS0) at rest and on movement (15° passive elevation) as PS0m will be recorded in the data collection sheet before PENG block or S-FICB administration and recorded on numeric pain rating scale (NRS). Pain score will be assessed via numerical pain rating scale (NRS) which the scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). The pain score will be categorised into mild pain (score of 1-4); moderate pain (score of 5-7) and severe pain (score of 8-10). The block will be performed by a single operator who has been trained to perform the block by a certified trained regional anaesthesia specialist (credentialed by performing at least 20 successful PENG and S-FICB block). The operator will undergo a probationary phase under supervision of a regional anaesthetist in UKMMC by performing at least 5 PENG and 5 S-FICB in HUKM. A report will be written to the committee regarding capability and safety of the operator before starting the study. In the PENG group, the participant will be placed in supine position and the monitoring devices will be applied as mentioned earlier and the baseline parameters will be recorded. The block will be administered under ultrasound guidance with a curvilinear probe/linear probe locating the iliopubic eminence, iliopsoas tendon and femoral artery. Stimuplex® needle, an echogenic needle that enables use of nerve stimulation and visualized under ultrasound in performing peripheral nerve blocks 100 mm 22 G will be advanced from lateral to medial approach until the needle tip reach the plane between the iliopsoas tendon and periosteum which is between anterior inferior iliac spine and iliopubic eminence. Next, 30 mls of local LA agent ropivacaine 0.2% will be injected. There will be total of 60 mg of Ropivacaine (maximum dose 3mg/kg). The 30 mls of LA solution (ropivacaine 0.2%) will be injected in 5 mls increments while observing for adequate fluid spread under ultrasound guided. Negative aspiration will be performed at the start of the injection and after each 5 mls of the injectate. The spread of LA below iliopsoas tendon and floating up iliopsoas tendon indicate correct LA distribution. Participants in group B (S-FICB group) will be positioned supine with extended hip, and any abdominal pannus will be retracted by an assistant or heavy tape. The anterior superior iliac spine (ASIS) will be located and the ultrasound probe will be placed slightly inferior and medial to ASIS with a parasagittal orientation and more perpendicular to the inguinal ligament. The iliacus muscle will be identified superficial to the ilium and the hyperechoic fascia iliaca will be identified on the superficial border of the muscle. Superficial to the fascia iliaca, there will be abdominal wall muscles meet those of the lower extremity at the inguinal ligament. The Stimuplex® needle will be inserted from the caudal directed cephalad in in-plane approach until the needle tip reach the fascia iliaca plane. Then, 1-2 mls of saline or local anaesthetic will be injected to confirm spread between the hyperechoic fascia iliaca and the more heterogeneous iliacus muscle beneath it. The 30 mls of LA solution (ropivacaine 0.2%) will be injected in 5 mls increments while observing for adequate fluid spread under ultrasound guided. Negative aspiration will be performed at the start of the injection and after each 5 mls of the injectate. In both the groups, the vital signs of participants, NIBP and ECG, respiratory rate (RR) and SpO2 will be evaluated at 5 minute intervals for 30 minute after the injection. Pain score will be assessed at 30 minute post bock during rest (PSPB) and on movement at 15° passive elevation (PSPBm). Pain score will be assessed via numerical pain rating scale (NRS) as explained above. If any patient has NRS> 4/10 then will be considered as failed block and will be dropped out from the study. The failed block participants will be managed by the attending anaesthetists in charged based on the standard protocol and rescue analgesia with IV fentanyl 50mcg will be given to the participant. All participants will be carefully observed to detect any symptoms of LA toxicity such as peri-oral and tongue numbness, dizziness, tinnitus, visual disturbances, seizure, unconscious, respiratory depression and cardiovascular depression as per standard protocol. Any paricipant who developed LA toxicity will be treated based on the standard management and will be dropped out from the study. After 30 minutes of observation following the block for both the groups, the participants will be pushed into the dedicated operating room and the spinal anaesthesia (SA) or combined spinal epidural anaesthesia (CSE) will be performed by the attending anaesthetists in charge based on the standard protocol. The attending anaesthetist will be blinded to the type of block provided for the participants. During the positioning for neuraxial anaesthesia, the pain score during the positioning will be assessed via NRS and the ease of positioning will be graded by the attending anaesthetist with the scale of 0-3 (0 = unable to position, 1= participant has abnormal posturing due to pain and require support for positioning, 2= mild discomfort but does not require support for positioning, 3=optimal condition where the participant is able to position himself/ herself without pain) as adopted from Jadon A. et al. Subsequent management of the participants throughout the surgery will be carried out by the attending anaesthetists as per standard protocol throughout the perioperative period. Post neuraxial anaesthesia the paricipants will be rated for satisfaction score via Likert scale for the block been given.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Hip Fractures Patients Going For Internal Fixation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
The recruited patients will be randomly divided into two groups via stratified randomization based on patient's hips fractures classification. Intra-articular fractures involving fractures within the hip joint. While extra-articular fractures are those fractures outside the capsule of the hip joint which are intertrochanteric and subtrochanteric. Two envelopes will be prepared which is intra-articular and extra-articular fractures envelope. In each envelope, there will be 10 "A" blocks and 10 "B" blocks.
Masking
ParticipantCare Provider
Masking Description
The recruited patients and the attending anaesthetist will be blinded to the type of block provided for the patient.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pericapsular nerve group (PENG) block
Arm Type
Active Comparator
Arm Description
The pericapsular nerve group (PENG) block is an ultrasound-guided approach, first described by Giron-Arango et al. for the blockade of the articular branches of the femoral, obturator and accessory obturator nerves that provide sensory innervation to the anterior hip capsule.
Arm Title
Supra-inguinal fascia iliaca compartment (S-FICB) block
Arm Type
Active Comparator
Arm Description
A supra-inguinal fascia iliaca compartment block (S-FICB), a 3 in 1 block involving femoral nerve , lateral femoral cutaneous nerve and obturator nerve.
Intervention Type
Procedure
Intervention Name(s)
Pericapsular nerve group (PENG) block
Intervention Description
In PENG group, the patient will be given PENG block 30mls of 0.2% ropivacaine
Intervention Type
Procedure
Intervention Name(s)
Supra-inguinal fascia iliaca compartment (S-FICB) block
Intervention Description
Patients in group B (S-FICB group) will be supra-inguinal fascia iliaca compartment block 30mls of 0.2% ropivacaine
Primary Outcome Measure Information:
Title
Pain score
Description
Baseline pain scores (PS0) at rest and on movement (15° passive elevation) as PS0m will be recorded in the data collection sheet before PENG block or S-FICB administration and recorded on numeric pain rating scale (NRS).Pain score will be assessed via numerical pain rating scale (NRS) which the scale is composed of 0 (no pain at all; the best scoring) to 10 (worst imaginable pain; the worst scoring). The pain score will be categorised into mild pain (score of 1-4); moderate pain (score of 5-7) and severe pain (score of 8-10). Pain score will be assessed at 30 minute post bock during rest (PSPB) and on movement at 15° passive elevation (PSPBm). Pain score during positioning during neuraxial anaesthesia also will be recorded.
Time Frame
30 minutes after intervention
Secondary Outcome Measure Information:
Title
Ease of positioning during neuraxial anaesthesia
Description
The ease of positioning will be graded by the attending anaesthetist with the scale of 0-3 (0 = unable to position, 1= patient has abnormal posturing due to pain and require support for positioning, 2= mild discomfort but does not require support for positioning, 3=optimal condition where the patient is able to position himself/ herself without pain)(The highest the score; the better the positional scoring)
Time Frame
30 minutes after intervention
Title
Patient satisfaction toward the block being given
Description
Post neuraxial anaesthesia the patients will be rated for satisfaction score via Likert scale for the block been given.(The higher the score; the better satisfaction toward the intervention)
Time Frame
30 minutes after neuraxial anaesthesia being given

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA I, II and III Hip fractures such as neck of femur (not older than 2 weeks and have persistent pain) Exclusion Criteria: Patients contraindicated to peripheral nerve blocks Patients with history of chronic pain Patients with significant cognitive impairment Patients with known allergic to study medications
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Siti Nidzwani Mohamad Mahdi Associate Profressor Datin Dr, MBBS
Phone
+6012-4210670
Ext
03-9145 5555
Email
nidzwani@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chong Kok Peng Dr, MD
Phone
+60163930729
Ext
03-9145 5555
Email
kokpeng5178@hotmail.com
Facility Information:
Facility Name
Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia
City
Cheras
State/Province
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siti Nidzwani Mohamad Mahdi Associate Profressor Dr, MBBS
Phone
012-4210670
Ext
03-9145 5555
Email
nidzwani@yahoo.com
First Name & Middle Initial & Last Name & Degree
Chong Kok Peng Dr, MD
Phone
+60163930729
Ext
03-9145 5555
Email
kokpeng5178@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Comparing The Effectiveness Of Pericapsular Nerve Group (PENG) Block Versus Supra-Inguinal Fascia Iliaca Compartment Block(S-FICB) In Reducing Positional Pain During Neuraxial Anaesthesia In Hip Fractures Patients

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