Clinical trial NCT07017192: OPPOSED (anteriOr hiP arthroPlasty regiOnal aneSthEsia stuDy) 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hip Replacement Surgery
Hip Replacement, Total
Hip Pain
Hip Arthroplasty
Hip Replacement Postoperative
Hip Surgery
Pain,Postoperative
Mobility and Independence
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of residual femoral and obturator nerves block in the two treatment groups
timeFrame: 8 hours after surgery
Secondary outcomes:
measure: Time elapsed between the end of surgery and the recovery of lower limb motility
timeFrame: 8 (or more) hours after surgery
measure: Total opioid consumption
timeFrame: 8, 24 and 48 hours after surgery
measure: Pain according to NRS (Numeric Rating Scale)
timeFrame: 8, 24 and 48 hours after surgery
measure: Extent of sensory block
timeFrame: 8, 24 and 48 hours after surgery
measure: Incidence of postoperative complications
timeFrame: Up to 48 hrs after surgery
measure: Timing of hospital discharge
timeFrame: From enrolment to the first follow up at 30 days
measure: Incidence of chronic or persistent postoperative pain
timeFrame: 30 and 90 days after surgery
measure: Incidence of acute side effects related to opioid use
timeFrame: Up to 48 hours after surgery
measure: Incidence of complications related to nerve blocks
timeFrame: up to 48 hours after surgery
Other outcomes:
Locations:
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza
state: TO
Study officials:
References: