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NCT Number: NCT07017192

OPPOSED (anteriOr hiP arthroPlasty regiOnal aneSthEsia stuDy) Study

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

Recruiting

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOU Città della Salute e della Scienza

Torino, TO, 10126, Italy

Location status: Recruiting

Location contact

Alessandro Massè, MD

SUB_INVESTIGATOR

Amedeo Burato, MD

SUB_INVESTIGATOR

Andrea D'Amelio, MD

SUB_INVESTIGATOR

Cecilia Crosetto, MD

CONTACT

[email protected]

+390116933818

Cecilia Crosetto, MD

SUB_INVESTIGATOR

Cecilia Giordano, MD

SUB_INVESTIGATOR

Chiara Busso, MD

SUB_INVESTIGATOR

Dario Bugada, MD

SUB_INVESTIGATOR

Marco Ulla, MD

CONTACT

[email protected]

+390116933818

Marco Ulla, MD

PRINCIPAL_INVESTIGATOR

Maurizio Berardino, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

SIFI Block

Procedure

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

ESP block

Procedure

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

Primary outcomes

  1. 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)

Secondary outcomes

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

    Time frame: 8 (or more) hours after surgery

    Ability of patient to mobilize independently within the room

  2. Total opioid consumption

    Time frame: 8, 24 and 48 hours after surgery

    Calculated as morphine equivalents

  3. Pain according to NRS (Numeric Rating Scale)

    Time frame: 8, 24 and 48 hours after surgery

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

  4. Extent of sensory block

    Time frame: 8, 24 and 48 hours after surgery

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

  5. Incidence of postoperative complications

    Time frame: Up to 48 hrs after surgery

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

  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

    Time frame: 30 and 90 days after surgery

    Follow-up by phone, using Brief Pain Inventory (presence of pain/localization/characteristics) and DN4 (neuropathic component) questionnaires.

  8. Incidence of acute side effects related to opioid use

    Time frame: Up to 48 hours after surgery

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

  9. Incidence of complications related to nerve blocks

    Time frame: up to 48 hours after surgery

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

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Ulla, MD

CONTACT

[email protected]

0039-3397548673

Sponsors and collaborators

Lead sponsor

A.O.U. Città della Salute e della Scienza

Other

Registry information

Official study title

OPPOSED (anteriOr hiP arthroPlasty regiOnal aneSthEsia stuDy) Study. Regional Anesthesia Techniques for Anterior Approach Hip Arthroplasty Analgesia: SIFI Block Versus Lumbar ESP Block

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2025
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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