Hip Replacement SurgeryNCT07017192
OPPOSED (anteriOr hiP arthroPlasty regiOnal aneSthEsia stuDy) Study
A study testing SIFI Block and ESP block in people with Hip Replacement Surgery and Hip Replacement, Total, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
Trial summary
Main indications for total hip arthroplasty (THA) are degenerative osteoarthritis of the coxofemoral joint, osteonecrosis of the hip, congenital disorders such as dysplasia and inflammatory arthritis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hip Replacement Surgery, Hip Replacement, Total, Hip Pain
- What is being tested?
- SIFI Block and ESP block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 23 Jun 2025to 23 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >=18 years and =<85 years
- patients undergoing elective unilateral THA with direct anterior approach
- patients able to understand the purposes of the study and provide signed informed consent
Who cannot join
- pregnancy
- Age <18 years or >85 years
- revision or bilateral surgeries
- psychiatric pathology or cognitive deficits, mental retardation, inability to provide valid informed consent
- History of illicit drugs and/or alcohol abuse
- urgent/emergent surgery with admission to Intensive Care under sedation and mechanical ventilation or complications that do not allow evaluation
- known allergy to the drugs used in the study
- refusal to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
AOU Città della Salute e della Scienza
Torino, TO, 10126
Marco Ulla, MD, +390116933818, marco.ulla@gmail.com
Cecilia Crosetto, MD, +390116933818, cecilia.crosetto@gmail.com
About this study
Official title: OPPOSED (anteriOr hiP arthroPlasty regiOnal aneSthEsia stuDy) Study. Regional Anesthesia Techniques for Anterior Approach Hip Arthroplasty Analgesia: SIFI Block Versus Lumbar ESP Block
Main indications for total hip arthroplasty (THA) are degenerative osteoarthritis of the coxofemoral joint, osteonecrosis of the hip, congenital disorders such as dysplasia and inflammatory arthritis. More recently, surgery using the direct anterior approach is getting popularity: this method, in fact, granting a significant sparing of the hip muscles, is associated with favorable results compared to other techniques, such as a lower risk of dislocation, limitated damage to soft tissues with better recovery and early discharge.
Patients undergoing this procedure may although experience moderate to severe postoperative pain in the first few hours (with peaks observed in the first 12 hours), as well as potential complications such as nausea and vomiting related to opioids use.
Read more
It has been shown that adequate pain control influences early mobilization and rehabilitation, ensuring a quicker recovery. The role of regional anesthesia techniques has been established in almost all areas of orthopedic surgery, and in particularly in the management of postoperative pain following hip replacement surgery, but definitive data are missing with regard to direct anterior approach.
Regional anesthesia consists of infiltrating local anesthetics in sites (fascial planes or nerves), in order to limit or even eliminate the use of traditional painkillers, with a significant reduction in the side effects.
The aim of this study is to compare the impact of two techniques, the Suprainguinal Fascia Iliaca (SIFI) block and the lumbar Erector Spinae Plane (ESP) block, in managing postoperative pain in subjects undergoing total hip replacement surgery performed by direct anterior approach.
The primary objective of the study is the incidence of residual femoral and obturator nerves block (knee extension and hip adduction according to ASIA score) 8 hours after surgery in the two treatment groups.
Secondary objectives include: • Time elapsed between the end of surgery and the recovery of lower limb motility enough to allow the patient to mobilize independently; • Total opioid consumption (calculated as morphine equivalents) at 8, 24 and 48 hours after surgery; • Pain according to NRS (numerica rating scale) at 8, 24 and 48 hours after surgery; • Extent of sensory block of the three branches of the lumbar plexus (femoral, obturator, lateral femorocutaneuous nerves) at 8, 24 and 48 hours after surgery; • Timing of hospital discharge; • Incidence of chronic or persistent postoperative pain (at 30 and 90 days after surgery); • Any postoperative complication
- Conditions
- Hip Replacement Surgery, Hip Replacement, Total, Hip Pain, Hip Arthroplasty, Hip Replacement Postoperative, Hip Surgery
- Being tested
- SIFI Block, ESP 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.
SIFI BlockProcedure or surgery
Infiltration of local anesthetics in the suprainguinal iliac fascia (Ropivacaine 0.375 40 mls)
ESP blockProcedure or surgery
Infiltration of local anesthetics in the fascial plane underneath the erector spoinae mulscle at lumbar level (Ropivacaine 0.375 40 mls)
| Study group | Role | What they receive |
|---|---|---|
| Subjects udergoing SIFI block | Experimental | Not described Receives: Procedure: SIFI Block |
| Subjects udergoing ESP block | Experimental | Not described Receives: Procedure: ESP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of residual femoral and obturator nerves block in the two treatment groups
(knee extension and hip adduction according to ASIA score)
Measured: 8 hours after surgery
Secondary outcomes (9)
Time elapsed between the end of surgery and the recovery of lower limb motility
Ability of patient to mobilize independently within the room
Measured: 8 (or more) hours after surgery
Total opioid consumption
Calculated as morphine equivalents
Measured: 8, 24 and 48 hours after surgery
Pain according to NRS (Numeric Rating Scale)
Scale 1-10 (1 corresponding to minimum and 10 corresponding to maximum pain perceived)
Measured: 8, 24 and 48 hours after surgery
Extent of sensory block
Clinical evaluation of the three branches of the lumbar plexus (femoral, obturator, lateral femorocutaneuous nerves)
Measured: 8, 24 and 48 hours after surgery
Incidence of postoperative complications
Bleeding, Bradyarrhythmic and/or hypotensive events, Nausea and Vomiting
Measured: Up to 48 hrs after surgery
Timing of hospital discharge
Measured: From enrolment to the first follow up at 30 days
Incidence of chronic or persistent postoperative pain
Follow-up by phone, using Brief Pain Inventory (presence of pain/localization/characteristics) and DN4 (neuropathic component) questionnaires.
Measured: 30 and 90 days after surgery
Incidence of acute side effects related to opioid use
excessive sedation, nausea and vomiting, respiratory depression, pruritus, urinary retention, constipation
Measured: Up to 48 hours after surgery
Incidence of complications related to nerve blocks
block failure, nerve damage, hematomas, systemic toxicity from local anesthetics
Measured: up to 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start23 Jun 2025
- Primary completion23 Oct 2026 (estimated)
- Study completion23 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Replacement 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017192
- Sponsor's protocol ID
- 77/2025
- Status last verified
- Aug 2026
- First submitted
- 22 May 2025
- Last updated
- 27 Aug 2026
- 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 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPPOSED (anteriOr hiP arthroPlasty regiOnal aneSthEsia stuDy) Study. Regional Anesthesia Techniques for Anterior Approach Hip Arthroplasty Analgesia: SIFI Block Versus Lumbar ESP Block
- ClinicalTrials.gov ID
- NCT07017192
- Acronym / sponsor ID
- 77/2025
- Conditions
- Hip Replacement Surgery, Hip Replacement, Total, Hip Pain, Hip Arthroplasty, Hip Replacement Postoperative, Hip Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 23 Oct 2026 (estimated)
- Study completion
- 23 Dec 2026 (estimated)
- First posted
- 12 Jun 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.
Main indications for total hip arthroplasty (THA) are degenerative osteoarthritis of the coxofemoral joint, osteonecrosis of the hip, congenital disorders such as dysplasia and inflammatory arthritis. More recently, surgery using the direct anterior approach is getting popularity: this method, in fact, granting a significant sparing of the hip muscles, is associated with favorable results compared to other techniques, such as a lower risk of dislocation, limitated damage to soft tissues with better recovery and early discharge.
Patients undergoing this procedure may although experience moderate to severe postoperative pain in the first few hours (with peaks observed in the first 12 hours), as well as potential complications such as nausea and vomiting related to opioids use.
It has been shown that adequate pain control influences early mobilization and rehabilitation, ensuring a quicker recovery. The role of regional anesthesia techniques has been established in almost all areas of orthopedic surgery, and in particularly in the management of postoperative pain following hip replacement surgery, but definitive data are missing with regard to direct anterior approach.
Regional anesthesia consists of infiltrating local anesthetics in sites (fascial planes or nerves), in order to limit or even eliminate the use of traditional painkillers, with a significant reduction in the side effects.
The aim of this study is to compare the impact of two techniques, the Suprainguinal Fascia Iliaca (SIFI) block and the lumbar Erector Spinae Plane (ESP) block, in managing postoperative pain in subjects undergoing total hip replacement surgery performed by direct anterior approach.
The primary objective of the study is the incidence of residual femoral and obturator nerves block (knee extension and hip adduction according to ASIA score) 8 hours after surgery in the two treatment groups.
Secondary objectives include: • Time elapsed between the end of surgery and the recovery of lower limb motility enough to allow the patient to mobilize independently; • Total opioid consumption (calculated as morphine equivalents) at 8, 24 and 48 hours after surgery; • Pain according to NRS (numerica rating scale) at 8, 24 and 48 hours after surgery; • Extent of sensory block of the three branches of the lumbar plexus (femoral, obturator, lateral femorocutaneuous nerves) at 8, 24 and 48 hours after surgery; • Timing of hospital discharge; • Incidence of chronic or persistent postoperative pain (at 30 and 90 days after surgery); • Any postoperative complication
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects udergoing SIFI block | Experimental | Procedure: SIFI Block |
| Subjects udergoing ESP block | Experimental | Procedure: ESP block |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >=18 years and =<85 years
- patients undergoing elective unilateral THA with direct anterior approach
- patients able to understand the purposes of the study and provide signed informed consent
Key exclusion criteria (8 listed)
- pregnancy
- Age <18 years or >85 years
- revision or bilateral surgeries
- psychiatric pathology or cognitive deficits, mental retardation, inability to provide valid informed consent
- History of illicit drugs and/or alcohol abuse
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 |
|---|---|---|
| SIFI BlockInfiltration of local anesthetics in the suprainguinal iliac fascia (Ropivacaine 0.375 40 mls) | Procedure or surgery | Subjects udergoing SIFI block |
| ESP blockInfiltration of local anesthetics in the fascial plane underneath the erector spoinae mulscle at lumbar level (Ropivacaine 0.375 40 mls) | Procedure or surgery | Subjects udergoing ESP block |
Primary outcome
Incidence of residual femoral and obturator nerves block in the two treatment groups
Time frame: 8 hours after surgery
(knee extension and hip adduction according to ASIA score)
9 secondary outcomes
Time elapsed between the end of surgery and the recovery of lower limb motility
Time frame: 8 (or more) hours after surgery
Total opioid consumption
Time frame: 8, 24 and 48 hours after surgery
Pain according to NRS (Numeric Rating Scale)
Time frame: 8, 24 and 48 hours after surgery
Extent of sensory block
Time frame: 8, 24 and 48 hours after surgery
Incidence of postoperative complications
Time frame: Up to 48 hrs after surgery
Timing of hospital discharge
Time frame: From enrolment to the first follow up at 30 days
Incidence of chronic or persistent postoperative pain
Time frame: 30 and 90 days after surgery
Incidence of acute side effects related to opioid use
Time frame: Up to 48 hours after surgery
Incidence of complications related to nerve blocks
Time frame: up to 48 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIFI Block and ESP block in people with Hip Replacement Surgery and Hip Replacement, Total, run by A.O.U. Città della Salute e della Scienza 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 27 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Ulla, MD (0039-3397548673, marco.ulla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of residual femoral and obturator nerves block in the two treatment groups (time frame: 8 hours after surgery). 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 2026.