Enhanced Recovery After SurgeryNCT05968014
Quality of Recovery After Hip Fracture Surgery: US-guided PENG Block Versus FICB
A study testing PENG vs FICB in people with Enhanced Recovery After Surgery, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
Patients were randomly divided into two groups to receive either ultrasound-guided pericapsular nerve group block (PENG group) or fascia iliaca compartment block (FICB group), using 20 ml of 0.2% ropivacaine Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Enhanced Recovery After Surgery
- What is being tested?
- PENG vs 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 siteTunisia
- Study dates
- 1 Feb 2022to 31 Jul 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- patients aged above 65 years
- patients with an american society of anesthesiologists physical status I to III
- patients undergoing hip fracture surgical repair
Who cannot join
- patients with an american society of anesthesiologists physical status IV or more
- inability or refusal to sign informed consent
- contraindications for regional nerve block or spinal anesthesia
- impaired cognition or dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Recovery After Hip Fracture Surgery: Ultrasound-guided Pericapsular Nerve Group Block Versus Fascia Iliaca Compartment Block
Patients were randomly divided into two groups to receive either ultrasound-guided pericapsular nerve group block (PENG group) or fascia iliaca compartment block (FICB group), using 20 ml of 0.2% ropivacaine
Read the detailed description
Participants were randomly divided into two groups : group PENG and group FICB, to receive either ultrasound-guided pericapsular nerve group block or fascia iliaca compartment block, using 50 ml of 0.2% ropivacaine.
For the FICB, a linear ultrasound probe was placed in the transverse plane and start scanning at the level of the inguinal crease to identify the femoral artery medially and the femoral nerve lateral to the femoral artery. The iliopsoas muscle should be seen overlying fascia iliaca. The block should be performed proximal to the arterial bifurcation. A 50 mm needle was introduced using an in-plane approach to penetrate the fascia iliaca. The hydro dissection separate the fascia iliaca from the iliac muscle, and a total volume of 20 ml of 0.2% ropivacaine was injected in this created space.
The PENG bloc is performed with a low frequency curvilinear ultrasound probe, which was initially placed in a transverse plane over the antero inferior iliac spine and the aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, it is possible to observe the iliopubic eminence, the iliopsoas muscle tendon, the femoral artery and the pectineus muscle. A 100 mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Negative aspiration should be observed before injection of local anaesthetic and a total volume of 20 ml of 0.2% ropivacaine was injected.
Spinal anesthesia was performed after 20 minutes.
QoR-15 score was assessed before the intervention and 24 hours postoperatively.
- Conditions
- Enhanced Recovery After Surgery
- Being tested
- PENG vs FICB
- Keywords
- hip fracture surgery, PENG block, fascia iliaca compartment block, quality of recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG vs FICBProcedure or surgery
pericapsular nerve group block versus fascia iliaca compartment block
| Study group | Role | What they receive |
|---|---|---|
| PENG block | Experimental | Participants enrolled in this group received a pericapsular nerve group block with 20 ml of 0.2% ropivacaine. The block was performed with a 100 mm needle, inserted with an in-plane lateral to medial approach. Operator used a low frequency curvilinear probe. Receives: Procedure: PENG vs FICB |
| FIC block | Experimental | Patients allocated in this group received a fascia iliaca compartment block with 20 mL of 0.2% ropivacaine, using a 50 mm needle inserted with an in-plane approach. Operator used a linear probe. Receives: Procedure: PENG vs FICB |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Quality of Recovery-15 scores at 24 hours postoperatively.
Change in Quality of Recovery-15 (QoR-15) scores before and 24 hours after surgery.
The QoR-15 score consists of 15 items, and includes five dimensions: pain (two items), physical confort (five items), physical independance (two items), psychological support (two items) and emotional state (four items). Each item's score ranged from 0 to 10, and the total score ranged from 0 to 150, with a higher QoR-15 score indicating a better quality of recovery.
Measured: before and 24 hours after surgery
Secondary outcomes (2)
The strength of the quadriceps
The strength of the quadriceps muscle was measured 24 hours after surgery. It was determined by testing the movement of the knee and the hip.
Measured: 24 hours after surgery
Visual analogue scale
change in visual analogue scale ((VAS) with 0 indicating no pain and 10 indicating the worst imaginable pain) at rest and on movement on postoperative day 1.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Feb 2022
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhanced Recovery After SurgeryStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomised-controlled trial with two parallel study groups. Participants will be randomised 1:1 to the PENG group or FICB group. The PENG group was treated with PENG block following randomisation, whereas the FICB group received a fascia iliaca compartment block.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaima Debabi, University Tunis El Manar
- Investigators
- Chaima Debabi, Principal investigator, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968014
- Sponsor's protocol ID
- Chaima Debabi
- Status last verified
- Jul 2023
- First submitted
- 11 Jul 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Recovery After Hip Fracture Surgery: Ultrasound-guided Pericapsular Nerve Group Block Versus Fascia Iliaca Compartment Block
- ClinicalTrials.gov ID
- NCT05968014
- Acronym / sponsor ID
- Chaima Debabi
- Conditions
- Enhanced Recovery After Surgery
- Keywords
- hip fracture surgery, PENG block, fascia iliaca compartment block, quality of recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 1 Aug 2023 (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.
Patients were randomly divided into two groups to receive either ultrasound-guided pericapsular nerve group block (PENG group) or fascia iliaca compartment block (FICB group), using 20 ml of 0.2% ropivacaine
Detailed description
Participants were randomly divided into two groups : group PENG and group FICB, to receive either ultrasound-guided pericapsular nerve group block or fascia iliaca compartment block, using 50 ml of 0.2% ropivacaine.
For the FICB, a linear ultrasound probe was placed in the transverse plane and start scanning at the level of the inguinal crease to identify the femoral artery medially and the femoral nerve lateral to the femoral artery. The iliopsoas muscle should be seen overlying fascia iliaca. The block should be performed proximal to the arterial bifurcation. A 50 mm needle was introduced using an in-plane approach to penetrate the fascia iliaca. The hydro dissection separate the fascia iliaca from the iliac muscle, and a total volume of 20 ml of 0.2% ropivacaine was injected in this created space.
The PENG bloc is performed with a low frequency curvilinear ultrasound probe, which was initially placed in a transverse plane over the antero inferior iliac spine and the aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, it is possible to observe the iliopubic eminence, the iliopsoas muscle tendon, the femoral artery and the pectineus muscle. A 100 mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Negative aspiration should be observed before injection of local anaesthetic and a total volume of 20 ml of 0.2% ropivacaine was injected.
Spinal anesthesia was performed after 20 minutes.
QoR-15 score was assessed before the intervention and 24 hours postoperatively.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomised-controlled trial with two parallel study groups. Participants will be randomised 1:1 to the PENG group or FICB group. The PENG group was treated with PENG block following randomisation, whereas the FICB group received a fascia iliaca compartment block.
| Arm | Type | Receives |
|---|---|---|
| PENG block | Experimental | Procedure: PENG vs FICBParticipants enrolled in this group received a pericapsular nerve group block with 20 ml of 0.2% ropivacaine. The block was performed with a 100 mm needle, inserted with an in-plane lateral to medial approach. Operator used a low frequency curvilinear probe. |
| FIC block | Experimental | Procedure: PENG vs FICBPatients allocated in this group received a fascia iliaca compartment block with 20 mL of 0.2% ropivacaine, using a 50 mm needle inserted with an in-plane approach. Operator used a linear probe. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- patients aged above 65 years
- patients with an american society of anesthesiologists physical status I to III
- patients undergoing hip fracture surgical repair
Key exclusion criteria (4 listed)
- patients with an american society of anesthesiologists physical status IV or more
- inability or refusal to sign informed consent
- contraindications for regional nerve block or spinal anesthesia
- impaired cognition or dementia
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 vs FICBpericapsular nerve group block versus fascia iliaca compartment block | Procedure or surgery | FIC block, PENG block |
Primary outcome
The Quality of Recovery-15 scores at 24 hours postoperatively.
Time frame: before and 24 hours after surgery
Change in Quality of Recovery-15 (QoR-15) scores before and 24 hours after surgery. The QoR-15 score consists of 15 items, and includes five dimensions: pain (two items), physical confort (five items), physical independance (two items), psychological support (two items) and emotional state (four items). Each item's score ranged from 0 to 10, and the total score ranged from 0 to 150, with a higher QoR-15 score indicating a better quality of recovery.
2 secondary outcomes
The strength of the quadriceps
Time frame: 24 hours after surgery
Visual analogue scale
Time frame: 24 hours after 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 5 Mar 2024.
- 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.
Chaima Debabi principal investigator
University Tunis El Manar
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 vs FICB in people with Enhanced Recovery After Surgery, run by University Tunis El Manar at 1 site in Tunisia.
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 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 5 Mar 2024. 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 Tunisia. 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?
The Quality of Recovery-15 scores at 24 hours postoperatively. (time frame: before and 24 hours after surgery). 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 5 Mar 2024.