Hip FracturesNCT04677348
Comparison of PENG Block and FICB in Hip Fracture Patients
A study testing Pericapsular nerve group (PENG) block and Fascia iliaca compartment block (FICB) in people with Hip Fractures and Regional Anesthesia, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Fascia iliaca compartment block (FICB) has been considered the block of choice for patients with hip fracture. However, pericapsular nerve group (PENG) block, one of the relatively newly-developed blocks, could be also used for analgesia in patients with hip fracture. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hip Fractures, Regional Anesthesia
- What is being tested?
- Pericapsular nerve group (PENG) block and Fascia iliaca compartment block (FICB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Jan 2021to 11 Feb 2022
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA PS 1-4
- age: ≥19
- baseline pain score (associated with hip fracture): ≥4
Who cannot join
- patients who do not agree to participate in this study
- patients with uncontrolled hypertension, hyperthyroidism, severe dementia
- allergic to ropivacaine
- contraindicated to spinal anesthesia due to coagulopathy, severe aortic stenosis/mitral stenosis, or active infection on lumbar region
- patients who are considered ineligible with any other reason by investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Analgesic Effect of Pericapsular Nerve Group Block and Suprainguinal Fascia Iliaca Compartment Block on Dynamic Pain in Patients Undergoing Hip Fracture Surgery: a Randomized Controlled Trial
Fascia iliaca compartment block (FICB) has been considered the block of choice for patients with hip fracture. However, pericapsular nerve group (PENG) block, one of the relatively newly-developed blocks, could be also used for analgesia in patients with hip fracture. Since PENG block could block the accessory obturator nerve, PENG block might have greater analgesic effects compared to FICB theoretically. However, the comparison of these two blocks in patients with hip fracture has not performed in clinical setting. Thus, we aimed to compare the analgesic effect of PENG block and FICB.
- Conditions
- Hip Fractures, Regional Anesthesia
- Being tested
- Pericapsular nerve group (PENG) block, Fascia iliaca compartment block (FICB)
- Keywords
- pericapsular nerve group block, fascia iliaca compartment block, hip fracture, regional anesthesia, dynamic pain
- 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
ultrasound-guided PENG block with 0.3% ropivacaine 20cc
Fascia iliaca compartment block (FICB)Procedure or surgery
ultrasound-guided suprainguinal FICB with 0.3% ropivacaine 30cc
| Study group | Role | What they receive |
|---|---|---|
| PENG group | Experimental | pericapsular nerve group (PENG) block before surgery Receives: Procedure: Pericapsular nerve group (PENG) block |
| FICB group | Active comparator | suprainguinal fascia iliaca compartment block (FICB) before surgery Receives: Procedure: Fascia iliaca compartment block (FICB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of each block (Pain score)
We will assess the dynamic pain (pain during a movement) using NRS before and 20-30min after applying the assigned block. Then, we will calculate the change of NRS at the two time-points.
NRS: Numerical rating scale (0, no pain; 10, the worst pain imaginable)
Measured: before surgery
Secondary outcomes (5)
change of blood pressure (systolic, diastolic, mean blood pressure)
We will evaluate the blood pressure before and 20-30min after applying the assigned block. Then, we will calculate the change of blood pressure at the two time-points.
Measured: before surgery
postoperative pain score
resting and dynamic pain using NRS at postoperative 6, 24, 48hours
NRS: Numerical rating scale (0, no pain; 10, the worst pain imaginable)
Measured: postoperative 6, 24, 48hours
postoperative opioid consumption
morphine-equivalent dose
Measured: postoperative 24, 48hours
postoperative motor function
motor function of quadriceps femoris
grade5: normal power grade4: movement possible against some resistance grade3: movement against gravity but not resistance grade2: movement possible if gravity eliminated grade1: flicker of contraction possible grade0: complete paralysis
Measured: postoperative 6, 24, 48hours
change of heart rate
We will evaluate the heart rate before and 20-30 min after applying the assigned block. Then, we will calculate the change of heart rate at the two time-points.
Measured: before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start21 Jan 2021
- Primary completion26 Jan 2022
- Study completion11 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hajung Kim, Asan Medical Center
- Investigators
- Won Uk Koh, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677348
- Sponsor's protocol ID
- 2020-1822
- Status last verified
- Mar 2022
- First submitted
- 10 Dec 2020
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koh WU, Kim H, Kim YJ, Park JI, Yeo HJ, Ro YJ, Kim HJ. Comparison of analgesic effect of pericapsular nerve group block and supra-inguinal fascia iliaca compartment block on dynamic pain in patients with hip fractures: a randomized controlled trial. Reg Anesth Pain Med. 2025 Aug 5;50(8):635-640. doi: 10.1136/rapm-2024-105627.
PubMed 38866559
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Effect of Pericapsular Nerve Group Block and Suprainguinal Fascia Iliaca Compartment Block on Dynamic Pain in Patients Undergoing Hip Fracture Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04677348
- Acronym / sponsor ID
- 2020-1822
- Conditions
- Hip Fractures, Regional Anesthesia
- Keywords
- pericapsular nerve group block, fascia iliaca compartment block, hip fracture, regional anesthesia, dynamic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 26 Jan 2022 (actual)
- Study completion
- 11 Feb 2022 (actual)
- First posted
- 21 Dec 2020 (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.
Fascia iliaca compartment block (FICB) has been considered the block of choice for patients with hip fracture. However, pericapsular nerve group (PENG) block, one of the relatively newly-developed blocks, could be also used for analgesia in patients with hip fracture. Since PENG block could block the accessory obturator nerve, PENG block might have greater analgesic effects compared to FICB theoretically. However, the comparison of these two blocks in patients with hip fracture has not performed in clinical setting. Thus, we aimed to compare the analgesic effect of PENG block and FICB.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PENG group | Experimental | Procedure: Pericapsular nerve group (PENG) blockpericapsular nerve group (PENG) block before surgery |
| FICB group | Active comparator | Procedure: Fascia iliaca compartment block (FICB)suprainguinal fascia iliaca compartment block (FICB) before surgery |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA PS 1-4
- age: ≥19
- baseline pain score (associated with hip fracture): ≥4
Key exclusion criteria (5 listed)
- patients who do not agree to participate in this study
- patients with uncontrolled hypertension, hyperthyroidism, severe dementia
- allergic to ropivacaine
- contraindicated to spinal anesthesia due to coagulopathy, severe aortic stenosis/mitral stenosis, or active infection on lumbar region
- patients who are considered ineligible with any other reason by investigators
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 (PENG) blockultrasound-guided PENG block with 0.3% ropivacaine 20cc | Procedure or surgery | PENG group |
| Fascia iliaca compartment block (FICB)ultrasound-guided suprainguinal FICB with 0.3% ropivacaine 30cc | Procedure or surgery | FICB group |
Primary outcome
Efficacy of each block (Pain score)
Time frame: before surgery
We will assess the dynamic pain (pain during a movement) using NRS before and 20-30min after applying the assigned block. Then, we will calculate the change of NRS at the two time-points. NRS: Numerical rating scale (0, no pain; 10, the worst pain imaginable)
5 secondary outcomes
change of blood pressure (systolic, diastolic, mean blood pressure)
Time frame: before surgery
postoperative pain score
Time frame: postoperative 6, 24, 48hours
postoperative opioid consumption
Time frame: postoperative 24, 48hours
postoperative motor function
Time frame: postoperative 6, 24, 48hours
change of heart rate
Time frame: before surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Derived from this study: PubMed 38866559Koh WU, Kim H, Kim YJ, Park JI, Yeo HJ, Ro YJ, Kim HJ. Comparison of analgesic effect of pericapsular nerve group block and supra-inguinal fascia iliaca compartment block on dynamic pain in patients with hip fractures: a randomized controlled trial. Reg Anesth Pain Med. 2025 Aug 5;50(8):635-640. doi: 10.1136/rapm-2024-105627.
- Individual participant dataSharing planned: No
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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.
Won Uk Koh, MD, PhD principal investigator
Asan Medical Center
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 (PENG) block and Fascia iliaca compartment block (FICB) in people with Hip Fractures and Regional Anesthesia, run by Asan Medical Center at 1 site in South Korea.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 23 Mar 2022. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of each block (Pain score) (time frame: before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04677348, which also lists 1 linked publication.
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 23 Mar 2022.