Supra Inguinal Fascia Iliaca Block as Rescue Analgesia Following Total Hip Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 310
- Locations
- 1
- Primary Endpoint
- Composite outcome
Study Overview
Brief Summary
Hip replacement surgery is one of the most commonly performed surgical procedures in France, with approximately 150,000 procedures per year. Postoperative recovery has significantly improved in recent years, enabling faster rehabilitation.
Although generally considered moderately painful, hip replacement surgery can, in some difficult-to-predict cases, lead to severe postoperative pain, requiring high doses of morphine, which may cause side effects and delay recovery.
In other surgical procedures, regional anesthesia (nerve blocks) has been successfully used for pain relief. However, its effectiveness after hip replacement surgery has not yet been fully proven.
A recent regional anesthesia technique-the Supra-Inguinal Fascia Iliaca Block (SIFIB)-which numbs a significant portion of the nerves around the hip, has recently been developed.
When performed in all patients undergoing hip arthroplasty, the benefit of this technique could not be demonstrated. In addition, this technique may lead to transcient muscle blockade, wich also can delay recovery.
In order to limit the use of nerve blocks to painful patients, we designed this study where the nerve block is performed only in patients experiencing significant paint after surgery.
In conclusion, this study aims to assess the benefits of performing a rescue SIFIB in the recovery room for patients who experience significant postoperative pain after hip replacement surgery. The evaluation will focus on pain relief and ability to walk.
No new treatment is being tested. The technique uses a commonly administered local anesthetic to numb the nerves.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patient scheduled for a primary total hip arthroplasty under general anesthesia,
- •written informed consent.
- •Non inclusion criteria:
- •contra indication to ropivacaine
- •vulnerable person
Exclusion Criteria
- •per-operative complication making wheight-bearing and walking contra-indicated.
- •patient without significant pain post-operatively.
Arms & Interventions
SIFIB group
The ultrasound probe is placed in a cephalo-caudal orientation, over the inguinal ligament, lateral to the femoral nerve. The iliacus muscle, which is covered caudally by the sartorius muscle and cephalically by the internal oblique muscle, is visualized in depth. Between these two muscles, an area is identified where the iliacus muscle is covered only by subcutaneous tissue. The needle is introduced in a cranio-caudal direction, and the injection is initiated in this area, beneath the fascia iliaca. The needle then advances through the space created by the injection, as far as possible in a cephalic direction, beneath the internal oblique muscle. An injection of 40 ml of 0.1% ropivacaine is administered.
Intervention: Ultrasound guided supra inguinal fascia iliaca block (Procedure)
SIFIB group
The ultrasound probe is placed in a cephalo-caudal orientation, over the inguinal ligament, lateral to the femoral nerve. The iliacus muscle, which is covered caudally by the sartorius muscle and cephalically by the internal oblique muscle, is visualized in depth. Between these two muscles, an area is identified where the iliacus muscle is covered only by subcutaneous tissue. The needle is introduced in a cranio-caudal direction, and the injection is initiated in this area, beneath the fascia iliaca. The needle then advances through the space created by the injection, as far as possible in a cephalic direction, beneath the internal oblique muscle. An injection of 40 ml of 0.1% ropivacaine is administered.
Intervention: Surgical and anesthetic protocol (Procedure)
Placebo group
Five milliliters of saline are injected subcutaneously under ultrasound guidance
Intervention: Placebo Injection (Procedure)
Placebo group
Five milliliters of saline are injected subcutaneously under ultrasound guidance
Intervention: Surgical and anesthetic protocol (Procedure)
Outcomes
Primary Outcomes
Composite outcome
Time Frame: 2 hours post operatively
Composite outcome is validated if all of these 3 items are validated: * numerical pain rating scale (from 0 to 10) at rest is \< 4, * and intravenous morphine \< 0,1 mg/kg, * and first mobilization successful. First mobilization is validated if patient can stand up, walk 5 meters then sit down in a wheelchair.
Secondary Outcomes
- Pain evaluation(6, 12 and 24 hours post operatively)
- Morphine consumption(24 hours post operatively)
- Length of hospital stay(An average of 2 to 3 days up to 1 week)
- Patient satisfaction(Day 1)
Investigators
Abderrahmen BARGAOUI
Principal Investigator
Institut Mutualiste Montsouris