Hip SurgeryESPTANCT07104097
Comparison Between 2 Techniques for Lumbar-ESPB
A study testing spinal anesthesia, superficial erector spinal plane block (ESPB) and deep (inter laminar) erector spinal plane block (ESPB) in people with Hip Surgery, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
Trial summary
Diffusion of local anesthetics after a lumbar ESPB within fascial planes towards nerve structures is a matter of debate. The main objective of the study is to compare the incidence of sensory block between two techniques of needle placement (superficial or translaminar) during lumbar ESPB block. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Surgery
- What is being tested?
- spinal anesthesia, superficial erector spinal plane block (ESPB) and deep (inter laminar) erector spinal plane block (ESPB)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 6 Oct 2025to 2 Jul 2026
- 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 total hip replacement
- informed consent
Who cannot join
- allergies to study drugs
- spinal anesthesia contraindicated
- kidney failure (GFR<30)
- epilepsy, psychiatric disease, neurologic deficits
- revision surgery
- neuropathies in the lumbar area (tingling, hypoestesia, numbness, motor deficit)
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- 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 Hip Arthroplasty- Comparison Between Two Techniques for Erector Spinae Plane Block
Diffusion of local anesthetics after a lumbar ESPB within fascial planes towards nerve structures is a matter of debate.
The main objective of the study is to compare the incidence of sensory block between two techniques of needle placement (superficial or translaminar) during lumbar ESPB block.
Patients are treated with lumbar ESPB (randomized to superficial or translaminar), spinal anesthesia and multimodal analgesia.
The primary endpoint will be the incidence of numbness/reduced skin sensitivity to cold (ice test) in the area innervated by the lumbar plexus. Secondary outcomes are pain and analgesic's consumption, motor block, quality of recovery and discharge ability.
- Conditions
- Hip Surgery
- Being tested
- spinal anesthesia, superficial erector spinal plane block (ESPB), deep (inter laminar) erector spinal plane block (ESPB), Dexamethasone, Ibuprofen 400 mg
- Keywords
- erector spinae plane block, hip surgery, sensory block, motor block, local anesthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesiaProcedure or surgery
spinal anesthesia at L3-L4 plain bupivacaine 0.5% 2.2 ml
superficial erector spinal plane block (ESPB)Procedure or surgery
Lidocaine 1% + ropivacaine 0.25% 30 ml with adrenaline 1:200.000 on top of L3 transverse process, between bone and erector spinae muscle
deep (inter laminar) erector spinal plane block (ESPB)Procedure or surgery
Lidocaine 1% + ropivacaine 0.25% 30 ml with adrenaline 1:200.000 between L3 and L4 transverse process, between erector spinae muscle and deep muscles
DexamethasoneDrug
8 mg iv preoperatively
Ibuprofen 400 mgDrug
preoperatively and postoperatively (every 8 hours)
ParacetamolDrug
1000 mg preoperatively and postoperatively (every 8 hours)
MorphineDrug
Patient Controlled Analgesia
| Study group | Role | What they receive |
|---|---|---|
| superficial ESPB | Active comparator | Injection on top of L3 transverse process, plane between bone and erector spinae muscle Receives: Procedure: spinal anesthesia; Procedure: superficial erector spinal plane block (ESPB); Drug: Dexamethasone; Drug: Ibuprofen 400 mg; Drug: Paracetamol; Drug: Morphine |
| deep ESPB | Experimental | Injection BETWEEN L3 and L4 transverse process, fascial plane between erector spinae muscle AND the deep muscles Receives: Procedure: spinal anesthesia; Procedure: deep (inter laminar) erector spinal plane block (ESPB); Drug: Dexamethasone; Drug: Ibuprofen 400 mg; Drug: Paracetamol; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensory block
incidence of reduced or abolished cold sensation on the skin in the territory of lumbar plexus (anterior, medial and lateral thigh)
Measured: 24 hours
Secondary outcomes (6)
motor block
block of extension and/or adduction of the thigh
Measured: 24 hours
postoperative pain
numeric rating scale - NRS 11 point scale from 0 = "no pain" to 10 = "worst imaginable pain"
Measured: 48 hours
morphine consumption
milligrams of morphine by patient controlled analgesia intravenously
Measured: 24 hours
quality of recovery
QoR-15 (Quality of Recovery 15 items) questionnaire - global measure of postoperative recovery, with a score ranging from 0 (extremely poor) to 150 (excellent)
Measured: 48 hours
complications
presence of nausea and vomiting, any other complication
Measured: 48 hours
discharge ability
PADDs score (Post Anaesthetic Discharge Scoring System) - 5 items, each scored from 0 to 2, where the higher the score (from 0 to 10), the greater the degree of the patient's recovery and readiness to be discharged. Scores of 9 or 10 mean the patient can be safely discharged.
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 Aug 2025
- Study start6 Oct 2025
- Primary completion30 Jun 2026
- Study completion2 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized trial, single blind
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 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
- NCT07104097
- Sponsor's protocol ID
- 0018028/25
- Acronym
- ESPTA
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Anesthesia in Hip Arthroplasty- Comparison Between Two Techniques for Erector Spinae Plane Block
- ClinicalTrials.gov ID
- NCT07104097
- Acronym / sponsor ID
- ESPTA / 0018028/25
- Conditions
- Hip Surgery
- Keywords
- erector spinae plane block, hip surgery, sensory block, motor block, local anesthetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Papa Giovanni XXIII HospitalUniversity, hospital or other
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 2 Jul 2026 (actual)
- First posted
- 5 Aug 2025 (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.
Diffusion of local anesthetics after a lumbar ESPB within fascial planes towards nerve structures is a matter of debate.
The main objective of the study is to compare the incidence of sensory block between two techniques of needle placement (superficial or translaminar) during lumbar ESPB block.
Patients are treated with lumbar ESPB (randomized to superficial or translaminar), spinal anesthesia and multimodal analgesia.
The primary endpoint will be the incidence of numbness/reduced skin sensitivity to cold (ice test) in the area innervated by the lumbar plexus. Secondary outcomes are pain and analgesic's consumption, motor block, quality of recovery and discharge ability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized trial, single blind
| Arm | Type | Receives |
|---|---|---|
| superficial ESPB | Active comparator | Procedure: spinal anesthesia, Procedure: superficial erector spinal plane block (ESPB), Drug: Dexamethasone, Drug: Ibuprofen 400 mg, Drug: Paracetamol, Drug: MorphineInjection on top of L3 transverse process, plane between bone and erector spinae muscle |
| deep ESPB | Experimental | Procedure: spinal anesthesia, Procedure: deep (inter laminar) erector spinal plane block (ESPB), Drug: Dexamethasone, Drug: Ibuprofen 400 mg, Drug: Paracetamol, Drug: MorphineInjection BETWEEN L3 and L4 transverse process, fascial plane between erector spinae muscle AND the deep muscles |
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 total hip replacement
- informed consent
Key exclusion criteria (10 listed)
- allergies to study drugs
- spinal anesthesia contraindicated
- kidney failure (GFR<30)
- 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 |
|---|---|---|
| spinal anesthesiaspinal anesthesia at L3-L4 plain bupivacaine 0.5% 2.2 ml | Procedure or surgery | deep ESPB, superficial ESPB |
| superficial erector spinal plane block (ESPB)Lidocaine 1% + ropivacaine 0.25% 30 ml with adrenaline 1:200.000 on top of L3 transverse process, between bone and erector spinae muscle | Procedure or surgery | superficial ESPB |
| deep (inter laminar) erector spinal plane block (ESPB)Lidocaine 1% + ropivacaine 0.25% 30 ml with adrenaline 1:200.000 between L3 and L4 transverse process, between erector spinae muscle and deep muscles | Procedure or surgery | deep ESPB |
| Dexamethasone8 mg iv preoperatively | Drug | deep ESPB, superficial ESPB |
| Ibuprofen 400 mgpreoperatively and postoperatively (every 8 hours) | Drug | deep ESPB, superficial ESPB |
| Paracetamol1000 mg preoperatively and postoperatively (every 8 hours) | Drug | deep ESPB, superficial ESPB |
| MorphinePatient Controlled Analgesia | Drug | deep ESPB, superficial ESPB |
Primary outcome
sensory block
Time frame: 24 hours
incidence of reduced or abolished cold sensation on the skin in the territory of lumbar plexus (anterior, medial and lateral thigh)
6 secondary outcomes
motor block
Time frame: 24 hours
postoperative pain
Time frame: 48 hours
morphine consumption
Time frame: 24 hours
quality of recovery
Time frame: 48 hours
complications
Time frame: 48 hours
discharge ability
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 25 Aug 2026.
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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 spinal anesthesia, superficial erector spinal plane block (ESPB) and deep (inter laminar) erector spinal plane block (ESPB) in people with Hip Surgery, 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 25 Aug 2026. 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?
sensory block (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 25 Aug 2026.