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

Sponsor
Clinique Medipole Garonne (Other)
Overall Status
Completed
CT.gov ID
NCT04499716
Collaborator
(none)
90
1
2
4.9
18.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: IPACK
  • Procedure: Femoral triangle block
  • Procedure: Obturator nerve block
  • Procedure: Femoral nerve block
  • Procedure: Sciatic nerve block
  • Procedure: Lateral femoral cutaneous nerve block
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Quadriblock Versus "IPACK + Femoral Triangle Block + Obturator Nerve Block" in Total Knee Arthroplasty: a Randomized Controlled Clinical Trial
Actual Study Start Date :
Dec 8, 2020
Actual Primary Completion Date :
May 7, 2021
Actual Study Completion Date :
May 7, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm 1: ITO group

Arm 1: IPACK combined with femoral triangle and obturator nerve blocks

Procedure: IPACK
25 milliliters of ropivacaine 0.3% will be injected between popliteal artery and femur.

Procedure: 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.

Procedure: 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.

Experimental: Arm 2 : Quadri-block group

Arm 2 : Femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks

Procedure: 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.

Procedure: Femoral nerve block
20 milliliters of ropivacaine 0.3% will be injected in supine position under the fascia iliaca lateral to the femoral artery.

Procedure: Sciatic nerve block
25 milliliters of ropivacaine 0.3% will be injected in prone position in the subgluteal space by lateral approach.

Procedure: Lateral femoral cutaneous nerve block
5 milliliters of ropivacaine 0.3% will be injected laterally to the sartorius muscle.

Outcome Measures

Primary Outcome Measures

  1. Postoperative analgesia, defined by the morphine consumption in the first 48 hours post-surgery. [48 hours]

    Total amount of oxynorm (mg) administered during the first 48 hours post-surgery.

Secondary Outcome Measures

  1. Postoperative pain: Verbal Rating Scale (VRS) [48 hours]

    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).

  2. Oxynorm consumption in the first 24 hours post-surgery [24 hours]

    Total amount of oxynorm (mg) administered during the first 24 hours post-surgery.

  3. Ability to walk [48 hours]

    0: unable to get up; 1: able to get up but not to walk; 2: walk <50 m; 3: walk > 50 m

  4. Quadricep mobilization [48 hours]

    0: paralysis; 1: paresis, 2: normal contraction

  5. Foot elevator muscle mobilization [48 hours]

    0: paralysis; 1: paresis; 2: normal contraction

  6. Side effects of opioids [48 hours]

    Collect side effects associated with oxynorm : nausea or vomiting, drowsiness, constipation, urinary retention, itching, disorientation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinique Médipôle Garonne Toulouse Haute-Garonne France 31036

Sponsors and Collaborators

  • Clinique Medipole Garonne

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Clinique Medipole Garonne
ClinicalTrials.gov Identifier:
NCT04499716
Other Study ID Numbers:
  • 2020/04
First Posted:
Aug 5, 2020
Last Update Posted:
Jun 7, 2021
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Clinique Medipole Garonne

Study Results

No Results Posted as of Jun 7, 2021