Hip FracturesPhase 4NCT06567522
Comparative Assessment of Effectiveness and Safety of L-ESPB Versus Absence of Locoregional Block in Hip Surgery
A Phase 4 study testing Lumbar Erector Spinae Plane Block. L bupivacaína 0.25% in people with Hip Fractures and Lumbar Erector Spinae Plane Block, run by Hospital Álvaro Cunqueiro at 1 site in Spain.
Trial summary
Hip surgery accounts for a high percentage of both emergency and elective surgical procedures in hospitals. Regardless of surgery being prescribed to treat a fracture or coxarthrosis, patients are usually elderly with multiple associated comorbidities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures, Lumbar Erector Spinae Plane Block
- What is being tested?
- Lumbar Erector Spinae Plane Block. L bupivacaína 0.25%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jun 2024to 31 Dec 2025
- Phase
- Phase 4
- 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
- Both sexes over 18 years of age having undergone hip surgery
- ASA I-III (classification system used by the American Society of Anesthesiologists where I is low anesthetic risk and IV is high risk)
- Capacity to comprehend the principles of pain assessment using the VAS visual analogue scale
- Previously signed an informed consent.
Who cannot join
- Contraindications for the technique and/or the drugs used in this context
- Technical inability to perform the block
- Severe cognitive impairment or prior mental disabilities described in their medical records
- Patients already included in other clinical trials.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, 36312
Laura García Reza, 626708239, laura.garcia.reza@sergas.es
About this study
Official title: Comparative Assessment of Effectiveness and Safety of Lumbar Erector Spinae Plane Block (L-ESPB) Versus Absence of Locoregional Block in Hip Surgery
Hip surgery accounts for a high percentage of both emergency and elective surgical procedures in hospitals. Regardless of surgery being prescribed to treat a fracture or coxarthrosis, patients are usually elderly with multiple associated comorbidities. When faced with this patient profile, there is a tendency to undertreat pain for fear of the side effects and pharmacological interactions of conventional analgesic drugs.
Ultrasound-guided regional anesthesia applied in orthopedic and trauma surgery has been shown to reduce the doses of opioids and conventional analgesics, to ease deambulation and early recovery, to improve respiratory dynamics and to reduce vein thrombosis and pneumonias. Our study aims to verify whether L-ESP block is effective in the hip and proximal femur surgeries and allows to lower the dosage of opioids in these patients.
- Conditions
- Hip Fractures, Lumbar Erector Spinae Plane Block
- Being tested
- Lumbar Erector Spinae Plane Block. L bupivacaína 0.25%
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Erector Spinae Plane Block. L bupivacaína 0.25%Drug
Ultrasound-guided ESP-L shall be carried out at the L3-14 level with 30 mL of levobupivacaine 0.25%
| Study group | Role | What they receive |
|---|---|---|
| ESP-L | Experimental | After hip fracture surgery ultrasound-guided ESP-L shall be carried out at the L3-14 level with 30 mL of levobupivacaine 0.25% Receives: Drug: Lumbar Erector Spinae Plane Block. L bupivacaína 0.25% |
| No ESP-L | No intervention | Conventional intravenous analgesia after hip fracture surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the analgesic effectiveness and safety of lumbar ESP block versus absence of block after hip and proximal femur surgeries by means of the VAS scale with pain reduction of at least 1 point in the first two hours after surgery.
Collect data on post-surgery pain using the Visual Analogue Scale (VAS).The VAS scale ranges from 0 to 10, with 0 being no pain and 10 being maximum pain.
Measured: 2 hours after surgery
Secondary outcomes (4)
Compare the analgesic postoperative needs after performing L-ESP block versus a control group of patients having undergone hip or proximal femur surgeries and the postoperative consumption of opioids in both groups
Consumption of morphine (mg)
Measured: 12 hours postoperative
Percentage of patients with technical ease to perform the esp-l block
We will define the technical ease of the esp-l block from 1 to 3. 1 being good and when we are able to clearly distinguish anatomical structures in order to carry out the locoregional analgesia, 2 would be equivalent to regular, when these are sensed but not clearly defined structures and bad when we are not able to distinguish any anatomical structure that allows us to carry out the block.
Measured: 48 hours postoperative
Patient satisfaction survey on pain management
We will classify patients into two groups according to their satisfaction with pain management in the postoperative period of hip surgery.
Being the group of patients who consider themselves satisfied with pain management when it meets their expectations and dissatisfied if the patients are discomforted with it.
Measured: 48 hours postoperative
Describe de side effects of the lumbar ESP block and morphine
pruritus, nausea, vomiting, erythema, hypotension
Measured: 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start8 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic single-centre parallel group randomized clinical trial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Álvaro Cunqueiro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura García Reza, Principal investigator, Hospital Álvaro Cunqueiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567522
- Sponsor's protocol ID
- ESPL - MORFINA
- Status last verified
- Aug 2024
- First submitted
- 10 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Garcia-Reza L, Raposeiras S, P Loureiro J, Pita-Romero R, Amate Pena JJ, Pereira Loureiro MA. Effectiveness and Safety of Lumbar Erector Spinae Plane Block Versus No Locoregional Block in Hip Surgery: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 15;14:e75854. doi: 10.2196/75854.
PubMed 40953436
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Assessment of Effectiveness and Safety of Lumbar Erector Spinae Plane Block (L-ESPB) Versus Absence of Locoregional Block in Hip Surgery
- ClinicalTrials.gov ID
- NCT06567522
- Acronym / sponsor ID
- ESPL - MORFINA
- Conditions
- Hip Fractures, Lumbar Erector Spinae Plane Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Hospital Álvaro CunqueiroUniversity, hospital or other
- Study start
- 8 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Aug 2024 (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.
Hip surgery accounts for a high percentage of both emergency and elective surgical procedures in hospitals. Regardless of surgery being prescribed to treat a fracture or coxarthrosis, patients are usually elderly with multiple associated comorbidities. When faced with this patient profile, there is a tendency to undertreat pain for fear of the side effects and pharmacological interactions of conventional analgesic drugs.
Ultrasound-guided regional anesthesia applied in orthopedic and trauma surgery has been shown to reduce the doses of opioids and conventional analgesics, to ease deambulation and early recovery, to improve respiratory dynamics and to reduce vein thrombosis and pneumonias. Our study aims to verify whether L-ESP block is effective in the hip and proximal femur surgeries and allows to lower the dosage of opioids in these patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Pragmatic single-centre parallel group randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| ESP-L | Experimental | Drug: Lumbar Erector Spinae Plane Block. L bupivacaína 0.25%After hip fracture surgery ultrasound-guided ESP-L shall be carried out at the L3-14 level with 30 mL of levobupivacaine 0.25% |
| No ESP-L | No intervention | –Conventional intravenous analgesia after hip fracture surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both sexes over 18 years of age having undergone hip surgery
- ASA I-III (classification system used by the American Society of Anesthesiologists where I is low anesthetic risk and IV is high risk)
- Capacity to comprehend the principles of pain assessment using the VAS visual analogue scale
- Previously signed an informed consent.
Key exclusion criteria (4 listed)
- Contraindications for the technique and/or the drugs used in this context
- Technical inability to perform the block
- Severe cognitive impairment or prior mental disabilities described in their medical records
- Patients already included in other clinical trials.
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 |
|---|---|---|
| Lumbar Erector Spinae Plane Block. L bupivacaína 0.25%Ultrasound-guided ESP-L shall be carried out at the L3-14 level with 30 mL of levobupivacaine 0.25% | Drug | ESP-L |
Primary outcome
To compare the analgesic effectiveness and safety of lumbar ESP block versus absence of block after hip and proximal femur surgeries by means of the VAS scale with pain reduction of at least 1 point in the first two hours after surgery.
Time frame: 2 hours after surgery
Collect data on post-surgery pain using the Visual Analogue Scale (VAS).The VAS scale ranges from 0 to 10, with 0 being no pain and 10 being maximum pain.
4 secondary outcomes
Compare the analgesic postoperative needs after performing L-ESP block versus a control group of patients having undergone hip or proximal femur surgeries and the postoperative consumption of opioids in both groups
Time frame: 12 hours postoperative
Percentage of patients with technical ease to perform the esp-l block
Time frame: 48 hours postoperative
Patient satisfaction survey on pain management
Time frame: 48 hours postoperative
Describe de side effects of the lumbar ESP block and morphine
Time frame: 48 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Derived from this study: PubMed 40953436Garcia-Reza L, Raposeiras S, P Loureiro J, Pita-Romero R, Amate Pena JJ, Pereira Loureiro MA. Effectiveness and Safety of Lumbar Erector Spinae Plane Block Versus No Locoregional Block in Hip Surgery: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 15;14:e75854. doi: 10.2196/75854.
- Individual participant dataSharing planned: Yes
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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.
Laura García Reza principal investigator
Hospital Álvaro Cunqueiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lumbar Erector Spinae Plane Block. L bupivacaína 0.25% in people with Hip Fractures and Lumbar Erector Spinae Plane Block, run by Hospital Álvaro Cunqueiro at 1 site in Spain.
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 4 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: status not confirmed, as of the sponsor's last update on 22 Aug 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura García Reza (626708239, laura.garcia.reza@sergas.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the analgesic effectiveness and safety of lumbar ESP block versus absence of block after hip and proximal femur surgeries by means of the VAS scale with pain reduction of at least 1 point in the first two hours after surgery. (time frame: 2 hours after surgery). 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 NCT06567522, which also lists 1 linked publication.
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 22 Aug 2024.