Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
ID07017192

OPPOSED Study Comparing SIFI Block Versus Lumbar ESP Block for Regional Anesthesia in Anterior Approach Hip Arthroplasty

Led by A.O.U. Città della Salute e della Scienza · Updated on 2025-06-29

50

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing two regional anesthesia techniques to manage postoperative pain in patients undergoing total hip replacement surgery using the direct anterior approach. This surgery is commonly done for conditions like degenerative osteoarthritis, osteonecrosis, congenital disorders such as dysplasia, and inflammatory arthritis. The direct anterior approach aims to spare hip muscles, reduce dislocation risk, limit soft tissue damage, and support quicker recovery, but patients can experience moderate to severe pain and opioid-related side effects after surgery. The study compares the Suprainguinal Fascia Iliaca (SIFI) block and the lumbar Erector Spinae Plane (ESP) block, both involving infiltration of local anesthetics (Ropivacaine 0.375, 40 mL) in specific nerve or fascial areas. Participants receive one of these two blocks during surgery. The primary focus is on nerve block incidence 8 hours post-surgery. Secondary goals include measuring recovery time for lower limb movement, opioid use, pain levels, sensory block extent, hospital discharge timing, and rates of chronic pain and complications up to 90 days after surgery. Participants will be monitored through physical assessments evaluating nerve function, pain using the Numeric Rating Scale, opioid consumption, and sensory nerve block at 8, 24, and 48 hours post-surgery. Researchers will also track postoperative complications, hospital discharge timing, and persistent pain at 30 and 90 days. The total involvement includes surgery, immediate postoperative monitoring, and follow-up visits to assess recovery and side effects.

CONDITIONS

Brief Title

OPPOSED (anteriOr hiP arthroPlasty regiOnal aneSthEsia stuDy) Study

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older and 85 years or younger
  • Patients undergoing elective unilateral total hip arthroplasty with direct anterior approach
  • Ability to understand the study purpose and provide signed informed consent
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Age younger than 18 years or older than 85 years
  • Revision or bilateral hip surgeries
  • Psychiatric disorders, cognitive deficits, mental retardation, or inability to provide valid informed consent
  • History of illicit drug or alcohol abuse
  • Urgent or emergency surgery with intensive care admission under sedation and mechanical ventilation or complications preventing evaluation
  • Known allergy to drugs used in the study
  • Refusal to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day of surgery

Participants receive regional anesthesia with either the SIFI block or the lumbar ESP block during their anterior approach hip arthroplasty surgery.

1 visit (in-person)

Post-operative Follow-up

Duration - Up to 48 hours after surgery

Participants are monitored for pain, opioid consumption, sensory block, and potential complications following surgery.

Visits at 8, 24, and 48 hours after surgery (in-person or remote assessments)

Follow-up

Duration - From enrollment to 90 days after surgery

Participants are followed to assess hospital discharge timing, incidence of chronic or persistent postoperative pain, and any late complications.

Visits at 30 and 90 days after surgery (in-person or remote)

Trial Site Locations

Total: 1 location

1

AOU Città della Salute e della Scienza

Torino, TO, Italy, 10126

Actively Recruiting

Loading map...

Research Team

M

Marco Ulla, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

Efficacy of Balance Rehabilitation Based on Serious Games in...

Hip Replacement, Total

Actively Recruiting

2 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here