Postoperative PainPTA-ALRNCT04574154
Regional Anesthesia in THR - Comparing the Analgesic Efficacy of Fascia Iliaca Block and Erector Spinae Plane Block
A study testing FIB, ESPB and spinal anesthesia in people with Postoperative Pain, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
Trial summary
THR (Total Hip Replacement) can be very painful and regional anesthesia is very effective in reducing postoperative pain. Fascia Iliaca Block (FIB) and Erector Spinae Plane Block (ESPB) are indirect approaches to the lumbar plexus that resulted to be very promising for THR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- FIB, ESPB and spinal anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jan 2020to 21 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary THR
- informed consent
Who cannot join
- allergies to study drugs
- spinal anesthesia contraindicated
- kidney failure
- epilepsy, psychiatric disease, neurologic deficits
- revision surgery
- neuropathies in the lumbar area
Show all 10Show fewer
- no informed consent
- pregnancy
- alcohol/opioid abuse
- emergency surgery/intensive care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Regional Anesthesia in THR - Comparing Analgesic Efficacy of Fascia Iliaca Block and Erector Spinae Plane Block
THR (Total Hip Replacement) can be very painful and regional anesthesia is very effective in reducing postoperative pain. Fascia Iliaca Block (FIB) and Erector Spinae Plane Block (ESPB) are indirect approaches to the lumbar plexus that resulted to be very promising for THR. However, no studies investigated the analgesic superiority of either FIB or ESPB. In our study the investigators compare FIB and ESPB in terms of pain relief expressed as morphine consumption in the first 24 hours after primary THR.
- Conditions
- Postoperative Pain
- Being tested
- FIB, ESPB, spinal anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIBProcedure or surgery
FIB with ultrasound: Ropivacaine 0.5% 40 ml
ESPBProcedure or surgery
ESPB (L4) with ultrasound: Ropivacaine 0.5% 40 ml
spinal anesthesiaProcedure or surgery
bupivacaine 0,5% 2.2 ml
| Study group | Role | What they receive |
|---|---|---|
| FIB | Experimental | ultrasound guided Fascia Iliaca Block Receives: Procedure: FIB; Procedure: spinal anesthesia |
| ESPB | Experimental | ultrasound guided Erector Spinae Plane Block Receives: Procedure: ESPB; Procedure: spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine
milligrams of morphine consumed in the first postoperative day
Measured: 24 hours
Secondary outcomes (3)
perceived postoperative pain: Numeric Rating Scale (NRS)
11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"
Measured: 24 hs
perceived postoperative pain: Numeric Rating Scale (NRS)
11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"
Measured: 48 hours
side effects
occurrence of nausea/vomiting, ileum, pruritus and urinary retention in the first 48 hours
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start20 Jan 2020
- Primary completion15 May 2021
- Study completion21 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papa Giovanni XXIII Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dario Bugada, Papa Giovanni XXIII Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574154
- Sponsor's protocol ID
- 191-19000
- Acronym
- PTA-ALR
- Status last verified
- Nov 2021
- First submitted
- 8 Jan 2020
- Last updated
- 9 Dec 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 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Anesthesia in THR - Comparing Analgesic Efficacy of Fascia Iliaca Block and Erector Spinae Plane Block
- ClinicalTrials.gov ID
- NCT04574154
- Acronym / sponsor ID
- PTA-ALR / 191-19000
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Papa Giovanni XXIII HospitalUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 21 Aug 2021 (actual)
- First posted
- 5 Oct 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.
THR (Total Hip Replacement) can be very painful and regional anesthesia is very effective in reducing postoperative pain. Fascia Iliaca Block (FIB) and Erector Spinae Plane Block (ESPB) are indirect approaches to the lumbar plexus that resulted to be very promising for THR. However, no studies investigated the analgesic superiority of either FIB or ESPB. In our study the investigators compare FIB and ESPB in terms of pain relief expressed as morphine consumption in the first 24 hours after primary THR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized trial
| Arm | Type | Receives |
|---|---|---|
| FIB | Experimental | Procedure: FIB, Procedure: spinal anesthesiaultrasound guided Fascia Iliaca Block |
| ESPB | Experimental | Procedure: ESPB, Procedure: spinal anesthesiaultrasound guided Erector Spinae Plane Block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- primary THR
- informed consent
Key exclusion criteria (10 listed)
- allergies to study drugs
- spinal anesthesia contraindicated
- kidney failure
- epilepsy, psychiatric disease, neurologic deficits
- revision surgery
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 |
|---|---|---|
| FIBFIB with ultrasound: Ropivacaine 0.5% 40 ml | Procedure or surgery | FIB |
| ESPBESPB (L4) with ultrasound: Ropivacaine 0.5% 40 ml | Procedure or surgery | ESPB |
| spinal anesthesiabupivacaine 0,5% 2.2 ml | Procedure or surgery | ESPB, FIB |
Primary outcome
morphine
Time frame: 24 hours
milligrams of morphine consumed in the first postoperative day
3 secondary outcomes
perceived postoperative pain: Numeric Rating Scale (NRS)
Time frame: 24 hs
perceived postoperative pain: Numeric Rating Scale (NRS)
Time frame: 48 hours
side effects
Time frame: 48 hours
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 Dec 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.
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 FIB, ESPB and spinal anesthesia in people with Postoperative Pain, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
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: finished, as of the sponsor's last update on 9 Dec 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 Italy. 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?
morphine (time frame: 24 hours). 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 9 Dec 2021.