Quadriblock Versus "IPACK + Femoral Triangle Block + Obturator Nerve Block" in Total Knee Arthroplasty

Primary Total Knee Arthroplasty Clinical Trial

— QuITO  

Official title:

Quadriblock Versus "IPACK + Femoral Triangle Block + Obturator Nerve Block" in Total Knee Arthroplasty: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04499716
• Other study ID #: 2020/04
• Status: Completed
• Phase: N/A
• Start date: December 8, 2020
• Est. completion date: May 7, 2021

Study information

• Verified date: July 2020
• Source: Clinique Medipole Garonne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Total knee arthroplasty (TKA) is one of the most common orthopedic surgical procedure and is associated with severe pain in the immediate postoperative period, thus limiting early recovery.

Postoperative pain management requires multimodal analgesia, combining drugs and injection of a local anesthetic (LA). For optimal pain management, several peripheral nerve blocks should be associated. Thus, a recent study shows that the combination of IPACK, femoral triangle and obturator nerve blocks (ITO blocks) provides an effective pain control after TKA.

The hypothesis of this study is that a quadruple nerve block combining femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks (quadri-block) could improve analgesia after TKA.

The main objective of this monocenter, prospective, randomized, open-label, controlled trial is to assess the effect of quadri-block on morphine consumption after TKA compared to ITO blocks.

Description:

In the pre-anaesthesia room, after the implementation of classical monitoring with an oxygen mask and a peripheral venous catheter, all patients will receive an antibioprophylaxis according to SFAR (French Society of Anesthesia & Intensive Care Medecine) recommendations and injection of 10 mg of IV dexamethasone.

The patients will be then randomized in 2 groups:

• ITO group (usual technique): IPACK combined to femoral triangle and obturator nerve blocks

• Quadriblock group (experimental technique): femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks.

An experienced anesthetist will perform ultrasound-guided blocks 30 minutes before surgery with ropivacaine 0.3%, total volume of 70 ml.

In the operating room, general anesthesia will be induced by intravenous ketamine (0.4 mg/kg) and propofol (3 mg/kg). Anesthesia will be maintained with propofol.

Postoperative analgesia protocol :

• Multimodal analgesia will be instituted from the end of the surgery by the administration of paracetamol (1 g) and ketoprofen (100 mg).

• In post-anesthesia care unit (PACU): oxynorm titration if VRS (pain score) >3 according to the centre's usual care.

• In ward: systematic per os analgesia with paracetamol (1 g, 4 times a day) and ibuprofen (400 mg, 3 times a day); oxynorm (10 mg, lockout interval: 4 h) if VRS (pain score) >3.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 7, 2021
• Est. primary completion date: May 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years and older,

• Primary total knee arthroplasty

• Consent for participation,

• Affiliation to a social security system

Exclusion Criteria:

• Preoperative morphine use

• Chronic pain syndrome

• Contraindication to any drugs used in the protocol (paracetamol, ketoprofen, oxynorm, propofol, ketamine, ropivacaine)

• Valgus > 9°

• Pregnant or breastfeeding women

• Patients under protection of the adults (guardianship, curators or safeguard of justice)

Related Conditions & MeSH terms

• Primary Total Knee Arthroplasty

Intervention

Procedure:
• IPACK
25 milliliters of ropivacaine 0.3% will be injected between popliteal artery and femur.
• Femoral triangle block
25 milliliters of ropivacaine 0.3% will be injected on the lateral side of the femoral artery at the distal part of the femoral triangle.
• Obturator nerve block
20 milliliters of ropivacaine 0.3% will be injected between the adductor magnus and adductor brevis muscles and between the adductor brevis muscle the pectineus.
• Femoral nerve block
20 milliliters of ropivacaine 0.3% will be injected in supine position under the fascia iliaca lateral to the femoral artery.
• Sciatic nerve block
25 milliliters of ropivacaine 0.3% will be injected in prone position in the subgluteal space by lateral approach.
• Lateral femoral cutaneous nerve block
5 milliliters of ropivacaine 0.3% will be injected laterally to the sartorius muscle.

Locations

Country	Name	City	State
France	Clinique Médipôle Garonne	Toulouse	Haute-Garonne

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Medipole Garonne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative analgesia, defined by the morphine consumption in the first 48 hours post-surgery.	Total amount of oxynorm (mg) administered during the first 48 hours post-surgery.	48 hours
Secondary	Postoperative pain: Verbal Rating Scale (VRS)	Pain will be assessed every 6 hours using a Verbal Rating Scale (VRS) ranging from 0 to 10 (0=no pain, 10=worst possible pain).	48 hours
Secondary	Oxynorm consumption in the first 24 hours post-surgery	Total amount of oxynorm (mg) administered during the first 24 hours post-surgery.	24 hours
Secondary	Ability to walk	0: unable to get up; 1: able to get up but not to walk; 2: walk <50 m; 3: walk > 50 m	48 hours
Secondary	Quadricep mobilization	0: paralysis; 1: paresis, 2: normal contraction	48 hours
Secondary	Foot elevator muscle mobilization	0: paralysis; 1: paresis; 2: normal contraction	48 hours
Secondary	Side effects of opioids	Collect side effects associated with oxynorm : nausea or vomiting, drowsiness, constipation, urinary retention, itching, disorientation.	48 hours