Pain, PostoperativeESFIBHANCT03860324
Erector Spinae vs Fascia Iliaca Block in Hip Arthroplasty
A study testing Single-shot erector spinae plane block and Single-shot fascia iliaca block in people with Pain, Postoperative, run by Hospital Beatriz Ângelo at 1 site in Portugal.
Trial summary
The thoracic erector spinae plane (ESP) block was first described by Forero et al in September 2016. In their article, the authors presented the possibility of using this block as an option for the control of thoracic neuropathic pain as well as post-operative thoracic pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Single-shot erector spinae plane block and Single-shot fascia iliaca block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Apr 2019to 31 Dec 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Surgical plan for total hip replacement
- Signing of consent form to participate in the study
Who cannot join
- Patient refusal
- BMI > 40 kg/m2
- Surgical plan for revision of hip replacement
- Patient unable to quantify pain level
- Chronic kidney disease with a Glomerular Filtration Rate < 50ml/min
- Previously medicated with opioids
Show all 10Show fewer
- Patient unable to perform the surgery with spinal block
- Allergy to local anesthetics
- Infection in the site of the Erector Spinae Plane or Fascia Iliaca block
- Allergy or contraindication to the use of morphine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erector Spinae vs Fascia Iliaca Block in Hip Arthroplasty Post-operative Analgesia With Erector Spinae Plane Block After Total Hip Replacement Surgery
The thoracic erector spinae plane (ESP) block was first described by Forero et al in September 2016. In their article, the authors presented the possibility of using this block as an option for the control of thoracic neuropathic pain as well as post-operative thoracic pain. The ESP block is done by administering local anesthetic in the plane deep to the erector spinae muscle, which spreads through the costotransverse foramen to the dorsal and ventral roots of the spinal nerves.
Since then, there have been reports about the successful use of this block for bariatric surgery, ventral hernia repair, radical mastectomy, rib fractures, major abdominal surgery and hip replacement. However, there are no studies in the literature comparing the efficacy of the ESP block to other nerve blocks.
The purpose of this study is to compare the post-operative analgesic efficacy of the ESP block to the fascia iliaca (FI) block after total hip replacement (THR).
- Conditions
- Pain, Postoperative
- Being tested
- Single-shot erector spinae plane block, Single-shot fascia iliaca block
- Keywords
- Hip Arthroplasty, Erector Spinae Plane 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.
Single-shot erector spinae plane blockProcedure or surgery
Single-shot Erector Spinae Plane block with 30ml of ropivacaine 0,5% + adrenaline 150mcg.
Single-shot fascia iliaca blockProcedure or surgery
Single-shot Fascia Iliaca block with 40ml of ropivacaine 0,2%
| Study group | Role | What they receive |
|---|---|---|
| Control-group | No intervention | No peripheral nerve block |
| Single-shot erector spinae plane block | Experimental | The patient is positioned in lateral decubitus. The anesthesiologist uses a linear high-frequency probe in a longitudinal direction laterally to the mid-sagittal plane at the level of L4 until the transverse process is identified and, more superficial, the erector spinae muscle. A 22G needle of 80mm is introduced in-plane craniocaudally towards the transverse process of L4 until its tip is in the plane deep to the erector spinae muscle. Single-shot block with 30ml of ropivacaine 0,5% + adrenaline 100mcg Receives: Procedure: Single-shot erector spinae plane block |
| Single-shot fascia iliaca block | Active comparator | The patient is positioned in dorsal decubitus. The anesthesiologist uses a linear high-frequency probe in a transversal direction, below the crural arch so as to identify the femoral artery. Afterwards the probe is moved laterally to find the iliac muscle and its fascia. A 22G needle of 80mm is introduced in-plane latero-medially until its tip is below the fascia iliaca (between the muscle and its fascia). Single-shot block with 40ml of ropivacaine 0,2%. Receives: Procedure: Single-shot fascia iliaca block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain level measured by the Visual Analog Scale
Measurement of patient's pain level using the Visual Analog Scale (with a score of 0-100, 0 being no pain and 100 maximum pain)
Measured: At 6 hours post-operative
Post-operative pain level measured by the Visual Analog Scale
Measurement of patient's pain level using the Visual Analog Scale (with a score of 0-100, 0 being no pain and 100 maximum pain)
Measured: At 12 hours post-operative
Post-operative pain level measured by the Visual Analog Scale
Measurement of patient's pain level using the Visual Analog Scale (with a score of 0-100, 0 being no pain and 100 maximum pain)
Measured: At 24 hours post-operative
Post-operative pain level measured by morphine consumption using patient-controlled intravenous analgesia
Total amount (in mg) of morphine administered by a patient-controlled intravenous analgesia pump of morphine 1mg/ml with bolus of 1ml per patient request with a lockout time of 10 minutes
Measured: At 24 hours post-operative
Secondary outcomes (5)
Muscle Strength grade
Muscle strength grade and comparison with the contralateral limb in the quadriceps femoris muscle
Muscle strength scale:
Grade 0: No muscle contraction is detected Grade 1: Muscle contraction is identified but it is insufficient to produce motion Grade 2: The muscle can move the joint only if the force of gravity is eliminated Grade 3: The muscle can move the joint against gravity but without any resistance Grade 4: The muscle can move the joint against moderate resistance Grade 5: The muscle can move the joint against full resistance
Measured: At 12 hours post-operative
Muscle Strength grade
Muscle strength grade and comparison with the contralateral limb in the quadriceps femoris muscle
Muscle strength scale:
Grade 0: No muscle contraction is detected Grade 1: Muscle contraction is identified but it is insufficient to produce motion Grade 2: The muscle can move the joint only if the force of gravity is eliminated Grade 3: The muscle can move the joint against gravity but without any resistance Grade 4: The muscle can move the joint against moderate resistance Grade 5: The muscle can move the joint against full resistance
Measured: At 24 hours post-operative
Sensory block assessed through a temperature test
Assessment of sensory block through a temperature test and comparison with the contralateral limb (sensory block vs no sensory block)
Measured: At 24 hours post-operative
Sensory block assessed through a tactile stimulation test
Assessment of sensory block through a tactile stimulation test and comparison with the contralateral limb (sensory block vs no sensory block)
Measured: At 24 hours post-operative
Detection of side effects related to the anesthetic and analgesic technique namely pruritus, urinary retention, nausea and vomiting in each patient
Presence of side effects (pruritus, urinary retention, nausea/vomiting)
Measured: At 24 hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion30 Jun 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Why it stopped: Cancelled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Beatriz Ângelo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, André Carrão, Hospital Beatriz Ângelo
- Investigators
- André Carrão, Principal investigator, Hospital Beatriz Ângelo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860324
- Sponsor's protocol ID
- 45149
- Acronym
- ESFIBHA
- Status last verified
- Aug 2021
- First submitted
- 24 Feb 2019
- Last updated
- 27 Aug 2021
- 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 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae vs Fascia Iliaca Block in Hip Arthroplasty Post-operative Analgesia With Erector Spinae Plane Block After Total Hip Replacement Surgery
- ClinicalTrials.gov ID
- NCT03860324
- Acronym / sponsor ID
- ESFIBHA / 45149
- Conditions
- Pain, Postoperative
- Keywords
- Hip Arthroplasty, Erector Spinae Plane Block
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Cancelled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital Beatriz ÂngeloUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 1 Mar 2019 (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.
The thoracic erector spinae plane (ESP) block was first described by Forero et al in September 2016. In their article, the authors presented the possibility of using this block as an option for the control of thoracic neuropathic pain as well as post-operative thoracic pain. The ESP block is done by administering local anesthetic in the plane deep to the erector spinae muscle, which spreads through the costotransverse foramen to the dorsal and ventral roots of the spinal nerves.
Since then, there have been reports about the successful use of this block for bariatric surgery, ventral hernia repair, radical mastectomy, rib fractures, major abdominal surgery and hip replacement. However, there are no studies in the literature comparing the efficacy of the ESP block to other nerve blocks.
The purpose of this study is to compare the post-operative analgesic efficacy of the ESP block to the fascia iliaca (FI) block after total hip replacement (THR).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control-group | No intervention | –No peripheral nerve block |
| Single-shot erector spinae plane block | Experimental | Procedure: Single-shot erector spinae plane blockThe patient is positioned in lateral decubitus. The anesthesiologist uses a linear high-frequency probe in a longitudinal direction laterally to the mid-sagittal plane at the level of L4 until the transverse process is identified and, more superficial, the erector spinae muscle. A 22G needle of 80mm is introduced in-plane craniocaudally towards the transverse process of L4 until its tip is in the plane deep to the erector spinae muscle. Single-shot block with 30ml of ropivacaine 0,5% + adrenaline 100mcg |
| Single-shot fascia iliaca block | Active comparator | Procedure: Single-shot fascia iliaca blockThe patient is positioned in dorsal decubitus. The anesthesiologist uses a linear high-frequency probe in a transversal direction, below the crural arch so as to identify the femoral artery. Afterwards the probe is moved laterally to find the iliac muscle and its fascia. A 22G needle of 80mm is introduced in-plane latero-medially until its tip is below the fascia iliaca (between the muscle and its fascia). Single-shot block with 40ml of ropivacaine 0,2%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Surgical plan for total hip replacement
- Signing of consent form to participate in the study
Key exclusion criteria (10 listed)
- Patient refusal
- BMI > 40 kg/m2
- Surgical plan for revision of hip replacement
- Patient unable to quantify pain level
- Chronic kidney disease with a Glomerular Filtration Rate < 50ml/min
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 |
|---|---|---|
| Single-shot erector spinae plane blockSingle-shot Erector Spinae Plane block with 30ml of ropivacaine 0,5% + adrenaline 150mcg. | Procedure or surgery | Single-shot erector spinae plane block |
| Single-shot fascia iliaca blockSingle-shot Fascia Iliaca block with 40ml of ropivacaine 0,2% | Procedure or surgery | Single-shot fascia iliaca block |
Primary outcome
Post-operative pain level measured by the Visual Analog Scale
Time frame: At 6 hours post-operative
Measurement of patient's pain level using the Visual Analog Scale (with a score of 0-100, 0 being no pain and 100 maximum pain)
Post-operative pain level measured by the Visual Analog Scale
Time frame: At 12 hours post-operative
Measurement of patient's pain level using the Visual Analog Scale (with a score of 0-100, 0 being no pain and 100 maximum pain)
Post-operative pain level measured by the Visual Analog Scale
Time frame: At 24 hours post-operative
Measurement of patient's pain level using the Visual Analog Scale (with a score of 0-100, 0 being no pain and 100 maximum pain)
Post-operative pain level measured by morphine consumption using patient-controlled intravenous analgesia
Time frame: At 24 hours post-operative
Total amount (in mg) of morphine administered by a patient-controlled intravenous analgesia pump of morphine 1mg/ml with bolus of 1ml per patient request with a lockout time of 10 minutes
5 secondary outcomes
Muscle Strength grade
Time frame: At 12 hours post-operative
Muscle Strength grade
Time frame: At 24 hours post-operative
Sensory block assessed through a temperature test
Time frame: At 24 hours post-operative
Sensory block assessed through a tactile stimulation test
Time frame: At 24 hours post-operative
Detection of side effects related to the anesthetic and analgesic technique namely pruritus, urinary retention, nausea and vomiting in each patient
Time frame: At 24 hours post-operative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- 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.
André Carrão principal investigator
Hospital Beatriz Ângelo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-shot erector spinae plane block and Single-shot fascia iliaca block in people with Pain, Postoperative, run by Hospital Beatriz Ângelo at 1 site in Portugal.
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 2 inclusion and 10 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: withdrawn, as of the sponsor's last update on 27 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 Portugal. 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 was withdrawn before enrolling participants, so there are no results.
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?
Post-operative pain level measured by the Visual Analog Scale (time frame: At 6 hours post-operative). The study lists 4 primary outcomes in all. 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 27 Aug 2021.