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Hip FracturesPhase 4NCT05721924

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

A Phase 4 study testing Pericapsular nerve group (PENG) block and Supra-inguinal fascia iliaca compartment (S-FICB) block in people with Hip Fractures, run by National University of Malaysia at 1 site in Malaysia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 80 years
Conditions the study is for
Hip Fractures
What is being tested?
Pericapsular nerve group (PENG) block and Supra-inguinal fascia iliaca compartment (S-FICB) block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteMalaysia
Study dates
1 Dec 2022to 30 Nov 2023
Phase
Phase 4
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 45 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ASA I, II and III
  • Hip fractures such as neck of femur (not older than 2 weeks and have persistent pain)

Who cannot join

  • Patients contraindicated to peripheral nerve blocks
  • Patients with history of chronic pain
  • Patients with significant cognitive impairment
  • Patients with known allergic to study medications

Trial locations and contacts

1 site in 1 country.

Siti Nidzwani Mohamad Mahdi Associate Profressor Datin Dr, MBBS contact

+6012-4210670 ext. 03-9145 5555

nidzwani@yahoo.com

Malaysia1 site, 1 recruiting
  • Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia

    Cheras, Kuala Lumpur, 56000

    Siti Nidzwani Mohamad Mahdi Associate Profressor Dr, MBBS, 012-4210670 ext. 03-9145 5555, nidzwani@yahoo.com

    Chong Kok Peng Dr, MD, +60163930729 ext. 03-9145 5555, kokpeng5178@hotmail.com

    Recruiting

Other trials in Malaysia

About this study

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.

Read the 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.

Conditions
Hip Fractures
Being tested
Pericapsular nerve group (PENG) block, Supra-inguinal fascia iliaca compartment (S-FICB) block
Keywords
Hip Fractures Patients Going For Internal Fixation
Medical subject headings
Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pericapsular nerve group (PENG) blockProcedure or surgery

    In PENG group, the patient will be given PENG block 30mls of 0.2% ropivacaine

  • Supra-inguinal fascia iliaca compartment (S-FICB) blockProcedure or surgery

    Patients in group B (S-FICB group) will be supra-inguinal fascia iliaca compartment block 30mls of 0.2% ropivacaine

Study groups in NCT05721924
Study groupRoleWhat they receive
Pericapsular nerve group (PENG) blockActive comparatorThe 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.
Receives: Procedure: Pericapsular nerve group (PENG) block
Supra-inguinal fascia iliaca compartment (S-FICB) blockActive comparatorA supra-inguinal fascia iliaca compartment block (S-FICB), a 3 in 1 block involving femoral nerve , lateral femoral cutaneous nerve and obturator nerve.
Receives: Procedure: Supra-inguinal fascia iliaca compartment (S-FICB) block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 minutes after intervention

Secondary outcomes (2)
  1. 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)

    Measured: 30 minutes after intervention

  2. 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)

    Measured: 30 minutes after neuraxial anaesthesia being given

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2023
  2. Study start1 Dec 2022
  3. Primary completion30 Sep 2023 (estimated)
  4. Study completion30 Nov 2023 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Double blind
Who is masked
Participant, Care provider
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05721924
Sponsor's protocol ID
FF-2022-336
Status last verified
Feb 2023
First submitted
26 Jan 2023
Last updated
10 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pericapsular nerve group (PENG) block and Supra-inguinal fascia iliaca compartment (S-FICB) block in people with Hip Fractures, run by National University of Malaysia at 1 site in Malaysia.

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 2 inclusion and 4 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 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Siti Nidzwani Mohamad Mahdi Associate Profressor Datin Dr, MBBS (+6012-4210670 ext. 03-9145 5555, nidzwani@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain score (time frame: 30 minutes after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 10 Feb 2023.

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