Acute PainNCT05154318
Efficacy of Pericapsular Nerve Group Block
A study testing Pericapsular Nerve Group Block and Fascia iliaca compartment block in people with Acute Pain, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Hip fracture is a common orthpaedic problem especially in elderly population. Fascia iliaca compartment block (FICB) and femoral nerve block are well-established technique as part of peri-operative multimodal analgesia for hip fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain
- What is being tested?
- Pericapsular Nerve Group Block and Fascia iliaca compartment block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Nov 2021to 31 Dec 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II
- Age 18 or above
- Scheduled for hip fracture corrective surgery in Queen Mary Hospital
- Chinese patients
- Able to provide informed oral and written consent
- Abbreviated Mental Test (AMT) 7 or above
Who cannot join
- Patient refusal
- ASA III or above
- Allergy to local anaesthetics, opioids, paracetamol, NSAID including COX-2 inhibitors
- Operation delayed for more than 2 days on admission
- Pre-existing peripheral neuropathy or history of stroke
- Preoperative non-walker
Show all 12Show fewer
- Pre-existing osteoarthritis of knee (KL grade 4)
- Multiple fractures (additional to hip fracture)
- Sepsis
- Impaired renal function (Defined as preoperative creatinine level >120 μmol or eGFR <50% of normal reference for their age group
- Patient with coagulopathy (Platelet < 100 or INR >1.5)
- Prior surgery at the inguinal or supra-inguinal area
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Timmy Chan
Hong Kong
Timmy Chan, MBBS, 22555791, timmychancw@gmail.com
About this study
Official title: Study Comparing the Efficacy of Pericapsular Nerve Group (PENG) Block and Facia Iliaca Compartment Block (FICB) in Hip Fracture - A Prospective Randomised Controlled Trial
Hip fracture is a common orthpaedic problem especially in elderly population. Fascia iliaca compartment block (FICB) and femoral nerve block are well-established technique as part of peri-operative multimodal analgesia for hip fractures. Reviews have shown peripheral nerve blocks including FICB, femoral nerve block and 3-in-1 block could reduce both pain and opioid consumption compared with systematic analgesia. However, there are also literature suggesting that some nerves that account for the major hip joint sensory innervation are not consistently covered. As a result, a new ultrasound guided regional technique, Pericapsular Nerve Group Block (PENG) was introduced in 2018. The primary aim of this study is to compare the analgesic effect of PENG block and FICB in terms of pain score during post-operative period. It also compares the range of movement, quadriceps power and other parameters related to physical functions of the operated hip as secondary outcomes.
Read the detailed description
Hip fracture is a common orthopaedic problem especially in elderly population. The number of hip fractures each year is expected to double from 2.2 million in 2017 to 4.5 million in 2050. It is the commonest reason for elderly to require hospitalisation and emergency operation. Significant morbidities such as pulmonary embolism, pneumonia and bed sore can be resulted from immobility and pain. Hip fracture also contributes to post-operative mortality at a rate about 8% at 1 month and 30% at 1 year.
Fascia iliaca compartment block (FICB) and femoral nerve block are well-established technique as part of peri-operative multimodal analgesia for hip fractures. Cochrane review has shown peripheral nerve blocks including FICB, Femoral nerve block and 3-in-1 block could reduce both pain at 30 minute and opioid consumption compared with systemic analgesia. In particular, FICB is found to be superior to opioids for pain control on movement, preoperative analgesic consumption, time to first analgesic request, and time to perform spinal anaesthesia. However, literature suggests that the obturator nerve is not consistently covered.
The anterior hip capsule which contributes the major hip joint sensory innervation is supplied by femoral nerve (FN), obturator nerve (ON) and accessory obturator nerve (AON). As a result, a novel ultrasound guided regional technique, Pericapsular Nerve Group Block (PENG) was introduced in 2018, targeting the above 3 nerves. This is very important as the obturator nerve is also blocked with this technique. Case reports showed reduction in pain scores compared with baseline 30 minutes after block placement and no clinically evident quadriceps weakness was detected.
- Conditions
- Acute Pain
- Being tested
- Pericapsular Nerve Group Block, Fascia iliaca compartment block
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular Nerve Group BlockProcedure or surgery
Nerve block targeting major hip joint sensory nerves.
Fascia iliaca compartment blockProcedure or surgery
Routine nerve block for hip fracture surgery.
| Study group | Role | What they receive |
|---|---|---|
| Pericapsular Nerve Group Block | Experimental | 30ml 0.3% Ropivacaine will be injected between psoas muscle and iliopubic eminence. Receives: Procedure: Pericapsular Nerve Group Block |
| Fascia iliaca compartment block | Active comparator | 30ml 0.3% Ropivacaine will be injected into fascia iliaca compartment. Receives: Procedure: Fascia iliaca compartment block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score at rest on postoperative day 1
Measure pain score at rest using numerical rating scale from 0 to 10, where 0 is no pain and 10 is the worst pain
Measured: on postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start15 Nov 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Chan Chi-Wing, The University of Hong Kong
- Investigators
- Timmy CW Chan, MBBS, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154318
- Sponsor's protocol ID
- UW21-382
- Status last verified
- Nov 2023
- First submitted
- 29 Nov 2021
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Comparing the Efficacy of Pericapsular Nerve Group (PENG) Block and Facia Iliaca Compartment Block (FICB) in Hip Fracture - A Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05154318
- Acronym / sponsor ID
- UW21-382
- Conditions
- Acute Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hip fracture is a common orthpaedic problem especially in elderly population. Fascia iliaca compartment block (FICB) and femoral nerve block are well-established technique as part of peri-operative multimodal analgesia for hip fractures. Reviews have shown peripheral nerve blocks including FICB, femoral nerve block and 3-in-1 block could reduce both pain and opioid consumption compared with systematic analgesia. However, there are also literature suggesting that some nerves that account for the major hip joint sensory innervation are not consistently covered. As a result, a new ultrasound guided regional technique, Pericapsular Nerve Group Block (PENG) was introduced in 2018. The primary aim of this study is to compare the analgesic effect of PENG block and FICB in terms of pain score during post-operative period. It also compares the range of movement, quadriceps power and other parameters related to physical functions of the operated hip as secondary outcomes.
Detailed description
Hip fracture is a common orthopaedic problem especially in elderly population. The number of hip fractures each year is expected to double from 2.2 million in 2017 to 4.5 million in 2050. It is the commonest reason for elderly to require hospitalisation and emergency operation. Significant morbidities such as pulmonary embolism, pneumonia and bed sore can be resulted from immobility and pain. Hip fracture also contributes to post-operative mortality at a rate about 8% at 1 month and 30% at 1 year.
Fascia iliaca compartment block (FICB) and femoral nerve block are well-established technique as part of peri-operative multimodal analgesia for hip fractures. Cochrane review has shown peripheral nerve blocks including FICB, Femoral nerve block and 3-in-1 block could reduce both pain at 30 minute and opioid consumption compared with systemic analgesia. In particular, FICB is found to be superior to opioids for pain control on movement, preoperative analgesic consumption, time to first analgesic request, and time to perform spinal anaesthesia. However, literature suggests that the obturator nerve is not consistently covered.
The anterior hip capsule which contributes the major hip joint sensory innervation is supplied by femoral nerve (FN), obturator nerve (ON) and accessory obturator nerve (AON). As a result, a novel ultrasound guided regional technique, Pericapsular Nerve Group Block (PENG) was introduced in 2018, targeting the above 3 nerves. This is very important as the obturator nerve is also blocked with this technique. Case reports showed reduction in pain scores compared with baseline 30 minutes after block placement and no clinically evident quadriceps weakness was detected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pericapsular Nerve Group Block | Experimental | Procedure: Pericapsular Nerve Group Block30ml 0.3% Ropivacaine will be injected between psoas muscle and iliopubic eminence. |
| Fascia iliaca compartment block | Active comparator | Procedure: Fascia iliaca compartment block30ml 0.3% Ropivacaine will be injected into fascia iliaca compartment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ASA I-II
- Age 18 or above
- Scheduled for hip fracture corrective surgery in Queen Mary Hospital
- Chinese patients
- Able to provide informed oral and written consent
Key exclusion criteria (12 listed)
- Patient refusal
- ASA III or above
- Allergy to local anaesthetics, opioids, paracetamol, NSAID including COX-2 inhibitors
- Operation delayed for more than 2 days on admission
- Pre-existing peripheral neuropathy or history of stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pericapsular Nerve Group BlockNerve block targeting major hip joint sensory nerves. | Procedure or surgery | Pericapsular Nerve Group Block |
| Fascia iliaca compartment blockRoutine nerve block for hip fracture surgery. | Procedure or surgery | Fascia iliaca compartment block |
Primary outcome
Pain score at rest on postoperative day 1
Time frame: on postoperative day 1
Measure pain score at rest using numerical rating scale from 0 to 10, where 0 is no pain and 10 is the worst pain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
Related trials for Acute Pain
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Apical Healing After Root Canal (re)Treatment With Laser-activated Irrigation Versus Sonic or no Activation
Apical Periodontitis, Post Operative Pain, Acute
RecruitingPhase 1/2
A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
Acute Postoperative Pain, Dental Pain
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timmy CW Chan, MBBS principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pericapsular Nerve Group Block and Fascia iliaca compartment block in people with Acute Pain, run by The University of Hong Kong at 1 site in Hong Kong.
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 6 inclusion and 12 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 1 Dec 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 Hong Kong. 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.
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 Timmy CW Chan, MBBS (22555679, timmychancw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score at rest on postoperative day 1 (time frame: on postoperative day 1). 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 1 Dec 2023.