OPPOSED (anteriOr hiP arthroPlasty regiOnal aneSthEsia stuDy) Study

NCT07017192 | Recruiting

• 1 other identifier: 77/2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Outcome Measures

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)

  8 hours after surgery

Secondary Outcomes (9)

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

  8 (or more) hours after surgery

• Total opioid consumption

  8, 24 and 48 hours after surgery

• Pain according to NRS (Numeric Rating Scale)

  8, 24 and 48 hours after surgery

• Extent of sensory block

  8, 24 and 48 hours after surgery

• Incidence of postoperative complications

  Up to 48 hrs after surgery

Study Arms (2)

Subjects udergoing SIFI block

EXPERIMENTAL

Procedure: SIFI Block

Subjects udergoing ESP block

EXPERIMENTAL

Procedure: ESP block

Interventions

SIFI Block PROCEDURE

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

Subjects udergoing SIFI block

ESP block PROCEDURE

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

Subjects udergoing ESP block

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

AOU Città della Salute e della Scienza

Torino, TO, 10126, Italy

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Marco Ulla, MD

CONTACT

0039-3397548673; marco.ulla@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 12, 2025
• Study Start: June 23, 2025
• Primary Completion (Estimated): June 23, 2026
• Study Completion (Estimated): September 23, 2026
• Last Updated: June 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)