OPPOSED (anteriOr hiP arthroPlasty regiOnal aneSthEsia stuDy) Study

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.

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 Overview

• Status: Recruiting
• Conditions: Hip Surgery; Hip Arthroplasty; Hip Replacement, Total; Hip Pain; Hip Replacement Postoperative; Hip Replacement Surgery; Mobility and Independence; Pain,Postoperative
• Intervention / Treatment: Procedure: SIFI Block; Procedure: ESP block

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marco Ulla, MD; Phone Number: 0039-3397548673; Email: marco.ulla@gmail.com

Study Locations

• Italy
  • TO
    • Torino, TO, Italy, 10126
      • Recruiting
      • AOU Città della salute e della scienza
      • Contact: Marco Ulla, MD; Phone Number: +390116933818; Email: marco.ulla@gmail.com
      • Contact: Cecilia Crosetto, MD; Phone Number: +390116933818; Email: cecilia.crosetto@gmail.com
      • Principal Investigator: Marco Ulla, MD
      • Sub-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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects udergoing SIFI block	Procedure: SIFI Block; Infiltration of local anesthetics in the suprainguinal iliac fascia (Ropivacaine 0.375 40 mls)
Experimental: Subjects udergoing ESP block	Procedure: ESP block; Infiltration of local anesthetics in the fascial plane underneath the erector spoinae mulscle at lumbar level (Ropivacaine 0.375 40 mls)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of residual femoral and obturator nerves block in the two treatment groups	(knee extension and hip adduction according to ASIA score)	8 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time elapsed between the end of surgery and the recovery of lower limb motility	Ability of patient to mobilize independently within the room	8 (or more) hours after surgery
Total opioid consumption	Calculated as morphine equivalents	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)	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)	8, 24 and 48 hours after surgery
Incidence of postoperative complications	Bleeding, Bradyarrhythmic and/or hypotensive events, Nausea and Vomiting	Up to 48 hrs after surgery
Timing of hospital discharge		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.	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	Up to 48 hours after surgery
Incidence of complications related to nerve blocks	block failure, nerve damage, hematomas, systemic toxicity from local anesthetics	up to 48 hours after surgery

Collaborators and Investigators

• Sponsor: A.O.U. Città della Salute e della Scienza

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2025
• Primary Completion (Estimated): June 23, 2026
• Study Completion (Estimated): September 23, 2026

Study Registration Dates

• First Submitted: May 22, 2025
• First Submitted That Met QC Criteria: June 11, 2025
• First Posted (Actual): June 12, 2025

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative
• Other Study ID Numbers: 77/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No