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RecruitingNCT07017192Updated Aug 27, 2026

OPPOSED (anteriOr hiP arthroPlasty regiOnal aneSthEsia stuDy) Study

An interventional study of SIFI Block and ESP block in Hip Replacement Surgery, Hip Replacement, Total and Hip Pain, sponsored by A.O.U. Città della Salute e della Scienza. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by A.O.U. Città della Salute e della Scienza · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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. 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

02

Conditions studied

  • Hip Replacement Surgery
  • Hip Replacement, Total
  • Hip Pain
  • Hip Arthroplasty
  • Hip Replacement Postoperative
  • Hip Surgery
  • Pain,Postoperative
  • Mobility and Independence

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03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Subjects udergoing SIFI block

    Procedure: SIFI Block

  • Experimental
    Subjects udergoing ESP block

    Procedure: ESP block

Interventions

  • ProcedureSIFI Block

    Infiltration of local anesthetics in the suprainguinal iliac fascia (Ropivacaine 0.375 40 mls)

  • ProcedureESP block

    Infiltration of local anesthetics in the fascial plane underneath the erector spoinae mulscle at lumbar level (Ropivacaine 0.375 40 mls)

05

What researchers measure

Primary outcomes

  1. Incidence of residual femoral and obturator nerves block in the two treatment groups

    (knee extension and hip adduction according to ASIA score)

    Time frame: 8 hours after surgery

Secondary outcomes

  1. Time elapsed between the end of surgery and the recovery of lower limb motility

    Ability of patient to mobilize independently within the room

    Time frame: 8 (or more) hours after surgery

  2. Total opioid consumption

    Calculated as morphine equivalents

    Time frame: 8, 24 and 48 hours after surgery

  3. Pain according to NRS (Numeric Rating Scale)

    Scale 1-10 (1 corresponding to minimum and 10 corresponding to maximum pain perceived)

    Time frame: 8, 24 and 48 hours after surgery

  4. Extent of sensory block

    Clinical evaluation of the three branches of the lumbar plexus (femoral, obturator, lateral femorocutaneuous nerves)

    Time frame: 8, 24 and 48 hours after surgery

  5. Incidence of postoperative complications

    Bleeding, Bradyarrhythmic and/or hypotensive events, Nausea and Vomiting

    Time frame: Up to 48 hrs after surgery

  6. Timing of hospital discharge

    Time frame: From enrolment to the first follow up at 30 days

  7. 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.

    Time frame: 30 and 90 days after surgery

  8. Incidence of acute side effects related to opioid use

    excessive sedation, nausea and vomiting, respiratory depression, pruritus, urinary retention, constipation

    Time frame: Up to 48 hours after surgery

  9. Incidence of complications related to nerve blocks

    block failure, nerve damage, hematomas, systemic toxicity from local anesthetics

    Time frame: up to 48 hours after surgery

06

Study locations

1 of 1 sites recruiting
  • AOU Città della Salute e della Scienza
    Torino, TO 10126, Italy
    • Marco Ulla, MD · Contact · marco.ulla@gmail.com · +390116933818
    • Cecilia Crosetto, MD · Contact · cecilia.crosetto@gmail.com · +390116933818
    • Marco Ulla, MD · Principal investigator
    • Cecilia Crosetto, MD · Sub investigator
    • Cecilia Giordano, MD · Sub investigator
    • Amedeo Burato, MD · Sub investigator
    • Andrea D'Amelio, MD · Sub investigator
    • Chiara Busso, MD · Sub investigator
    • Dario Bugada, MD · Sub investigator
    • Alessandro Massè, MD · Sub investigator
    • Maurizio Berardino, MD · Sub investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07017192
Lead sponsor
A.O.U. Città della Salute e della Scienza
Responsible party
Sponsor
First posted
Jun 12, 2025
Start date
Jun 23, 2025
Primary completion
Oct 23, 2026 (estimated)
Completion
Dec 23, 2026 (estimated)
Last update
Aug 27, 2026

Study contacts

Marco Ulla, MD
Contact
marco.ulla@gmail.com
0039-3397548673

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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