Postoperative ComplicationsNCT04402450
Suprainguinal Fascia Iliaca Block Versus PENG Block for Hip Arthroplasty Analgesia
A study testing Ultrasound-guided suprainguinal fascia iliaca nerve block and Ultrasound-guided pericapsular nerves group of the hip block in people with Postoperative Complications and Postoperative Pain, run by University of Chile at 1 site in Chile.
Trial summary
In recent years, suprainguinal fascia iliaca block (SFIB) has emerged as a reliable analgesic option for primary total hip arthroplasty (THA). In 2018, a new block was described, termed pericapsular nerve group block or PENG block, that selectively targets the articular branches of the femoral and obturator nerves… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Complications, Postoperative Pain, Weakness, Muscle
- What is being tested?
- Ultrasound-guided suprainguinal fascia iliaca nerve block and Ultrasound-guided pericapsular nerves group of the hip block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChile
- Study dates
- 31 Aug 2020to 28 May 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years
- American Society of Anesthesiologists classification 1-3
- Body mass index between 20 and 35 (kg/m2)
Who cannot join
- Adults who are unable to give their own consent
- Pre-existing neuropathy (assessed by history and physical examination)
- Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤a100, International Normalized Ratio ≥01.4 or prothrombin time ≥ 50)
- Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
- Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
- Allergy to local anesthetics (LAs)
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- Pregnancy
- Prior surgery in the corresponding side of the inguinal or suprainguinal area
- Chronic pain syndromes requiring opioid intake at home
Trial locations and contacts
1 site in 1 country.
Chile1 site
Hospital Clínico Universidad de Chile
Santiago, Metropolitan, 8380456
About this study
Official title: A Randomized Comparison Between Ultrasound-Guided Suprainguinal Fascia Iliaca Block and Pericapsular Nerve Group Block For Total Hip Replacement
In recent years, suprainguinal fascia iliaca block (SFIB) has emerged as a reliable analgesic option for primary total hip arthroplasty (THA). In 2018, a new block was described, termed pericapsular nerve group block or PENG block, that selectively targets the articular branches of the femoral and obturator nerves while sparing their motor components. In this randomized trial, the investigators will compare US-guided SFIB and PENG block in patients undergoing primary THA. Since the main benefit of PENGB stems from its quadriceps-sparing effect, it was selected the incidence of quadriceps motor block (at 6 hours) as the primary outcome and the hypothesis that PENG block will result in significantly less motor block compared to SFIB.
- Being tested
- Ultrasound-guided suprainguinal fascia iliaca nerve block, Ultrasound-guided pericapsular nerves group of the hip block
- Medical subject headings
- Postoperative Complications, Pain, Postoperative, Muscle Weakness, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided suprainguinal fascia iliaca nerve blockProcedure or surgery
After an ultrasound-guided insertion of a block needle below the inguinal ligament, the needle will be advance in the plane between fascia iliaca and iliopsoas muscle up to a point cranial to the ligament in order to inject a 40 mL of adrenalized 0.25% levobupivacaine.
Ultrasound-guided pericapsular nerves group of the hip blockProcedure or surgery
After an ultrasound-guided insertion of a block needle at the level of the inguinal ligament, the needle will be advance into the plane between iliac bone periosteum and the tendon of the iliopsoas muscle in order to inject 20 mL of adrenalized 0.5% levobupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| suprainguinal fascia iliaca block | Active comparator | Forty mL of levobupivacaine 0.25% with epinephrine 5 ug/mL will be injected cranial to the inguinal ligament between the fascia iliaca and the iliopsoas muscle. Receives: Procedure: Ultrasound-guided suprainguinal fascia iliaca nerve block |
| Pericapsular nerve group block | Experimental | Twenty mL of levobupivacaine 0.5% with epinephrine 5 ug/mL will be deposited in the anterior aspect of the iliac bone between its periosteum and the tendon of the iliopsoas muscle. Receives: Procedure: Ultrasound-guided pericapsular nerves group of the hip block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of quadriceps motor block (defined as paralysis or paresis).
Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).
Measured: 6 hours after block performance
Secondary outcomes (24)
Block performance time
temporal interval between the start of skin disinfection and the end of LA injection through the block needle
Measured: 1 hour after surgery
Static and dynamic pain
Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Measured: 3 hours after the block
Static and dynamic pain
Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Measured: 6 hours after the block
Static and dynamic pain
Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Measured: 12 hours after the block
Static and dynamic pain
Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Measured: 18 hours after the block
Static and dynamic pain
Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Measured: 24 hours after the block
Static and dynamic pain
Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Measured: 36 hours after the block
Static and dynamic pain
Pain intensity at rest and during active movement using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Measured: 48 hours after the block
Postoperative morphine consumption
consumption of intravenous morphine registered by a patient controlled analgesia device
Measured: 24 hours after the block
Postoperative morphine consumption
consumption of intravenous morphine registered by a patient controlled analgesia device
Measured: 48 hours after the block
Sensory block
Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch)
Measured: 3 hours after the block
Sensory block
Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch)
Measured: 6 hours after the block
Sensory block
Sensory block in the anterior, lateral and medial aspects of the mid-thigh. For each territory, blockade will be evaluated using a 3-point scale: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot feel touch)
Measured: 24 hours after the block
Presence of quadriceps motor block (defined as paralysis or paresis).
Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).
Measured: 3 hours after the block
Presence of quadriceps motor block (defined as paralysis or paresis).
Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).
Measured: 24 hours after the block
Hip adduction strength.
Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively.
Measured: 3 hours after the block
Hip adduction strength.
Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively.
Measured: 6 hours after the block
Hip adduction strength.
Hip adduction will be evaluated by comparing it to baseline strength (i.e., prior to spinal anesthesia). A blood pressure cuff, inflated at 40 mmHg, will be inserted between the knees of the patient: the latter will then be instructed to squeeze the cuff as hard as possible and to sustain the effort. We will define hip adduction scores of 0, 1 and 2 points as decreases in strength of 0-20%, 21-70% and 71-90% compared to baseline measurement, respectively.
Measured: 24 hours after the block
Block-related complications
vascular puncture, paresthesia or systemic local anesthetic toxicity
Measured: 1 hour after the block
Postoperative opioid related side effects
Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression
Measured: 48 hours after the block
Inability to perform physiotherapy due to motor block
Number of participants that cannot end the physiotherapy protocol programmed for the first postoperative day secondary to decreased strength in the operated leg.
Measured: Postoperative day 1
Inability to perform physiotherapy due to motor block
Number of participants that cannot end the physiotherapy protocol programmed for the second postoperative day secondary to decreased strength in the operated leg.
Measured: postoperative day 2
Inability to perform physiotherapy due to pain
Number of participants that cannot end the physiotherapy protocol programmed for the first postoperative day secondary to pain in the operated leg.
Measured: postoperative day 1
Inability to perform physiotherapy due to pain
Number of participants that cannot end the physiotherapy protocol programmed for the second postoperative day secondary to pain in the operated leg.
Measured: postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start31 Aug 2020
- Primary completion25 May 2021
- Study completion28 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective randomized comparison between two analgesic techniques
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julian Aliste, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402450
- Sponsor's protocol ID
- OAIC 1111/20
- Status last verified
- Sep 2021
- First submitted
- 13 May 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: unidentified data can be shared upon reasonable request after study publication
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 30063657Hebbard P, Ivanusic J, Sha S. Ultrasound-guided supra-inguinal fascia iliaca block: a cadaveric evaluation of a novel approach. Anaesthesia. 2011 Apr;66(4):300-5. doi: 10.1111/j.1365-2044.2011.06628.x. Epub 2011 Feb 24.
PubMed 21401544Aliste J, Layera S, Bravo D, Jara A, Munoz G, Barrientos C, Wulf R, Branez J, Finlayson RJ, Tran Q. Randomized comparison between pericapsular nerve group (PENG) block and suprainguinal fascia iliaca block for total hip arthroplasty. Reg Anesth Pain Med. 2021 Oct;46(10):874-878. doi: 10.1136/rapm-2021-102997. Epub 2021 Jul 20.
PubMed 34290085
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison Between Ultrasound-Guided Suprainguinal Fascia Iliaca Block and Pericapsular Nerve Group Block For Total Hip Replacement
- ClinicalTrials.gov ID
- NCT04402450
- Acronym / sponsor ID
- OAIC 1111/20
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 26 May 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.
In recent years, suprainguinal fascia iliaca block (SFIB) has emerged as a reliable analgesic option for primary total hip arthroplasty (THA). In 2018, a new block was described, termed pericapsular nerve group block or PENG block, that selectively targets the articular branches of the femoral and obturator nerves while sparing their motor components. In this randomized trial, the investigators will compare US-guided SFIB and PENG block in patients undergoing primary THA. Since the main benefit of PENGB stems from its quadriceps-sparing effect, it was selected the incidence of quadriceps motor block (at 6 hours) as the primary outcome and the hypothesis that PENG block will result in significantly less motor block compared to SFIB.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective randomized comparison between two analgesic techniques
| Arm | Type | Receives |
|---|---|---|
| suprainguinal fascia iliaca block | Active comparator | Procedure: Ultrasound-guided suprainguinal fascia iliaca nerve blockForty mL of levobupivacaine 0.25% with epinephrine 5 ug/mL will be injected cranial to the inguinal ligament between the fascia iliaca and the iliopsoas muscle. |
| Pericapsular nerve group block | Experimental | Procedure: Ultrasound-guided pericapsular nerves group of the hip blockTwenty mL of levobupivacaine 0.5% with epinephrine 5 ug/mL will be deposited in the anterior aspect of the iliac bone between its periosteum and the tendon of the iliopsoas muscle. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 80 years
- American Society of Anesthesiologists classification 1-3
- Body mass index between 20 and 35 (kg/m2)
Key exclusion criteria (9 listed)
- Adults who are unable to give their own consent
- Pre-existing neuropathy (assessed by history and physical examination)
- Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤a100, International Normalized Ratio ≥01.4 or prothrombin time ≥ 50)
- Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
- Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
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 |
|---|---|---|
| Ultrasound-guided suprainguinal fascia iliaca nerve blockAfter an ultrasound-guided insertion of a block needle below the inguinal ligament, the needle will be advance in the plane between fascia iliaca and iliopsoas muscle up to a point cranial to the ligament in order to inject a 40 mL of adrenalized 0.25% levobupivacaine. | Procedure or surgery | suprainguinal fascia iliaca block |
| Ultrasound-guided pericapsular nerves group of the hip blockAfter an ultrasound-guided insertion of a block needle at the level of the inguinal ligament, the needle will be advance into the plane between iliac bone periosteum and the tendon of the iliopsoas muscle in order to inject 20 mL of adrenalized 0.5% levobupivacaine. | Procedure or surgery | Pericapsular nerve group block |
Primary outcome
Presence of quadriceps motor block (defined as paralysis or paresis).
Time frame: 6 hours after block performance
Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).
24 secondary outcomes
Block performance time
Time frame: 1 hour after surgery
Static and dynamic pain
Time frame: 3 hours after the block
Static and dynamic pain
Time frame: 6 hours after the block
Static and dynamic pain
Time frame: 12 hours after the block
Static and dynamic pain
Time frame: 18 hours after the block
Static and dynamic pain
Time frame: 24 hours after the block
Static and dynamic pain
Time frame: 36 hours after the block
Static and dynamic pain
Time frame: 48 hours after the block
Postoperative morphine consumption
Time frame: 24 hours after the block
Postoperative morphine consumption
Time frame: 48 hours after the block
Sensory block
Time frame: 3 hours after the block
Sensory block
Time frame: 6 hours after the block
Sensory block
Time frame: 24 hours after the block
Presence of quadriceps motor block (defined as paralysis or paresis).
Time frame: 3 hours after the block
Presence of quadriceps motor block (defined as paralysis or paresis).
Time frame: 24 hours after the block
Hip adduction strength.
Time frame: 3 hours after the block
Hip adduction strength.
Time frame: 6 hours after the block
Hip adduction strength.
Time frame: 24 hours after the block
Block-related complications
Time frame: 1 hour after the block
Postoperative opioid related side effects
Time frame: 48 hours after the block
Inability to perform physiotherapy due to motor block
Time frame: Postoperative day 1
Inability to perform physiotherapy due to motor block
Time frame: postoperative day 2
Inability to perform physiotherapy due to pain
Time frame: postoperative day 1
Inability to perform physiotherapy due to pain
Time frame: postoperative day 2
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 28 Sep 2021.
- Results publication: 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.
- Results publication: PubMed 21401544Hebbard P, Ivanusic J, Sha S. Ultrasound-guided supra-inguinal fascia iliaca block: a cadaveric evaluation of a novel approach. Anaesthesia. 2011 Apr;66(4):300-5. doi: 10.1111/j.1365-2044.2011.06628.x. Epub 2011 Feb 24.
- Derived from this study: PubMed 34290085Aliste J, Layera S, Bravo D, Jara A, Munoz G, Barrientos C, Wulf R, Branez J, Finlayson RJ, Tran Q. Randomized comparison between pericapsular nerve group (PENG) block and suprainguinal fascia iliaca block for total hip arthroplasty. Reg Anesth Pain Med. 2021 Oct;46(10):874-878. doi: 10.1136/rapm-2021-102997. Epub 2021 Jul 20.
- Individual participant dataSharing planned: No. unidentified data can be shared upon reasonable request after study publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided suprainguinal fascia iliaca nerve block and Ultrasound-guided pericapsular nerves group of the hip block in people with Postoperative Complications and Postoperative Pain, run by University of Chile at 1 site in Chile.
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 9 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 28 Sep 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 Chile. 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?
Presence of quadriceps motor block (defined as paralysis or paresis). (time frame: 6 hours after block performance). 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 NCT04402450, which also lists 3 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 28 Sep 2021.