Anesthesia, ConductionNCT04996290
Combined PENG and LFCN Block for Total Hip Arthroplasty
A study testing PENG + LFCN block and Ropivacaine injection in people with Anesthesia, Conduction and Pain, Postoperative, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
A clinical trial investigating the effect of a combined locoregional anesthesia technique on the postoperative analgesia outcomes after a total hip arthroplasty. A PENG block will be used in combination with a LFCN block. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anesthesia, Conduction, Pain, Postoperative, Arthroplasty, Replacement, Hip
- What is being tested?
- PENG + LFCN block and Ropivacaine injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2020to 1 Oct 2020
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients who underwent a primary total hip replacement under general anesthesia
Who cannot join
- insulin dependent diabetes mellitus
- chronic pain
- severe dementia or mental retardation
- allergy to local anesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Block for Total Hip Arthroplasty: A Randomized Controlled Trial
A clinical trial investigating the effect of a combined locoregional anesthesia technique on the postoperative analgesia outcomes after a total hip arthroplasty. A PENG block will be used in combination with a LFCN block. The results will be compared to a control group that is solely treated with intravenous analgesia. This technique aims to provide improved pain scores after surgery without interference of revalidation.
- Being tested
- PENG + LFCN block, Ropivacaine injection
- Keywords
- regional anesthesia, postoperative pain, total hip arthroplasty, pericapsular nerve group block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG + LFCN blockProcedure or surgery
Also called pericapsular nerve group block, lateral femoral cutaneous nerve block
Regional anesthesia technique
Ropivacaine injectionDrug
Also called ropivacaine 0.375%
Local anesthetic used for peripheral nerve block.
| Study group | Role | What they receive |
|---|---|---|
| PENG + LFCN block | Active comparator | The participants in this group received a combined regional technique just before surgery:
* Pericapsular nerve group (PENG) block
* Lateral femoral cutaneus nerve (LFCN) block Receives: Procedure: PENG + LFCN block; Drug: Ropivacaine injection |
| No regional anesthesia | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial pain score
numeric rating score (NRS) of 0 to 10
Measured: 0 hours postoperative
Pain score after 2h
numeric rating score (NRS) of 0 to 10
Measured: 2 hours postoperative
Pain score after 24h
numeric rating score (NRS) of 0 to 10
Measured: 24 hours postoperative
Secondary outcomes (5)
Initial motor function
score chart inspired by the Bromage score (NRS) of 0 to 3
Measured: 0 hours postoperative
Motor function after 2h
score chart inspired by the Bromage score (NRS) of 0 to 3
Measured: 2 hours postoperative
Motor function after 24h
score chart inspired by the Bromage score (NRS) of 0 to 3
Measured: 24 hours postoperative
Intraoperative opioids
dose of intravenous opioids in microgram per kilogram bodyweight
Measured: intraoperative
Postoperative opioids
dose of intravenous opioids in microgram per kilogram bodyweight
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start1 Jun 2020
- Primary completion30 Sep 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, ConductionStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe 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
- Model description
- prospective randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lennert De Schrijver, University Hospital, Antwerp
- Investigators
- Yzabel Vandevivere, MD, Principal investigator, AZ Monica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996290
- Sponsor's protocol ID
- B3002020000032
- Status last verified
- Aug 2021
- First submitted
- 19 Jul 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30063657Morrison C, Brown B, Lin DY, Jaarsma R, Kroon H. Analgesia and anesthesia using the pericapsular nerve group block in hip surgery and hip fracture: a scoping review. Reg Anesth Pain Med. 2021 Feb;46(2):169-175. doi: 10.1136/rapm-2020-101826. Epub 2020 Oct 27.
PubMed 33109730Wainwright TW, Gill M, McDonald DA, Middleton RG, Reed M, Sahota O, Yates P, Ljungqvist O. Consensus statement for perioperative care in total hip replacement and total knee replacement surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Acta Orthop. 2020 Feb;91(1):3-19. doi: 10.1080/17453674.2019.1683790. Epub 2019 Oct 30.
PubMed 31663402Roy R, Agarwal G, Pradhan C, Kuanar D. Total postoperative analgesia for hip surgeries, PENG block with LFCN block. Reg Anesth Pain Med. 2019 Mar 28:rapm-2019-100454. doi: 10.1136/rapm-2019-100454. Online ahead of print. No abstract available.
PubMed 30923252Hojer Karlsen AP, Geisler A, Petersen PL, Mathiesen O, Dahl JB. Postoperative pain treatment after total hip arthroplasty: a systematic review. Pain. 2015 Jan;156(1):8-30. doi: 10.1016/j.pain.0000000000000003.
PubMed 25599296
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Block for Total Hip Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04996290
- Acronym / sponsor ID
- B3002020000032
- Keywords
- regional anesthesia, postoperative pain, total hip arthroplasty, pericapsular nerve group block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 9 Aug 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.
A clinical trial investigating the effect of a combined locoregional anesthesia technique on the postoperative analgesia outcomes after a total hip arthroplasty. A PENG block will be used in combination with a LFCN block. The results will be compared to a control group that is solely treated with intravenous analgesia. This technique aims to provide improved pain scores after surgery without interference of revalidation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| PENG + LFCN block | Active comparator | Procedure: PENG + LFCN block, Drug: Ropivacaine injectionThe participants in this group received a combined regional technique just before surgery: * Pericapsular nerve group (PENG) block * Lateral femoral cutaneus nerve (LFCN) block |
| No regional anesthesia | No intervention | –Control group |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients who underwent a primary total hip replacement under general anesthesia
Key exclusion criteria (4 listed)
- insulin dependent diabetes mellitus
- chronic pain
- severe dementia or mental retardation
- allergy to local anesthetics
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 |
|---|---|---|
| PENG + LFCN blockAlso: pericapsular nerve group block, lateral femoral cutaneous nerve blockRegional anesthesia technique | Procedure or surgery | PENG + LFCN block |
| Ropivacaine injectionAlso: ropivacaine 0.375%Local anesthetic used for peripheral nerve block. | Drug | PENG + LFCN block |
Primary outcome
Initial pain score
Time frame: 0 hours postoperative
numeric rating score (NRS) of 0 to 10
Pain score after 2h
Time frame: 2 hours postoperative
numeric rating score (NRS) of 0 to 10
Pain score after 24h
Time frame: 24 hours postoperative
numeric rating score (NRS) of 0 to 10
5 secondary outcomes
Initial motor function
Time frame: 0 hours postoperative
Motor function after 2h
Time frame: 2 hours postoperative
Motor function after 24h
Time frame: 24 hours postoperative
Intraoperative opioids
Time frame: intraoperative
Postoperative opioids
Time frame: 24 hours postoperative
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 9 Aug 2021.
- Background: PubMed 30063657Giron-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.
- Background: PubMed 33109730Morrison C, Brown B, Lin DY, Jaarsma R, Kroon H. Analgesia and anesthesia using the pericapsular nerve group block in hip surgery and hip fracture: a scoping review. Reg Anesth Pain Med. 2021 Feb;46(2):169-175. doi: 10.1136/rapm-2020-101826. Epub 2020 Oct 27.
- Background: PubMed 31663402Wainwright TW, Gill M, McDonald DA, Middleton RG, Reed M, Sahota O, Yates P, Ljungqvist O. Consensus statement for perioperative care in total hip replacement and total knee replacement surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Acta Orthop. 2020 Feb;91(1):3-19. doi: 10.1080/17453674.2019.1683790. Epub 2019 Oct 30.
- Background: PubMed 30923252Roy R, Agarwal G, Pradhan C, Kuanar D. Total postoperative analgesia for hip surgeries, PENG block with LFCN block. Reg Anesth Pain Med. 2019 Mar 28:rapm-2019-100454. doi: 10.1136/rapm-2019-100454. Online ahead of print. No abstract available.
- Background: PubMed 25599296Hojer Karlsen AP, Geisler A, Petersen PL, Mathiesen O, Dahl JB. Postoperative pain treatment after total hip arthroplasty: a systematic review. Pain. 2015 Jan;156(1):8-30. doi: 10.1016/j.pain.0000000000000003.
- 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.
Yzabel Vandevivere, MD principal investigator
AZ Monica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PENG + LFCN block and Ropivacaine injection in people with Anesthesia, Conduction and Pain, Postoperative, run by University Hospital, Antwerp at 1 site in Belgium.
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 1 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: finished, as of the sponsor's last update on 9 Aug 2021. 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 Belgium. 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?
Initial pain score (time frame: 0 hours postoperative). The study lists 3 primary outcomes in all. 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 NCT04996290, which also lists 5 linked publications.
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 9 Aug 2021.