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IPACK Block After Total Knee Arthroplasty

Primary Purpose

Knee Arthropathy, Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
adductor canal block
IPACK block
Sponsored by
University Tunis El Manar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Arthropathy focused on measuring knee arthoplasty, nerve block, analgesia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • primary total knee arthroplasty under spinal anesthesia

Exclusion Criteria:

  • Contraindication or refusal to regional anesthesia
  • Contraindication to non steroidal anti inflammatory (NSAID's)
  • Allergy to opioids
  • Allergy to paracetamol
  • Creatinine clearance < 30ml/min
  • Weight<50 kg or >100kg

Sites / Locations

  • Institut Kassab D'OrthopedieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Canal adductor block

IPACK block

Arm Description

ACB was done in the immediate postoperative period under a high-frequency ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.2% ropivacaine was injected in the canal using a 22-gauge 100-mm short-beveled regional block needle and a catheter was kept for 48H with 4 ml/h ropivacaine 0.2%.

IPACK was realized after spinal anesthesia. Patient was placed in a supine position and knee placed in position of 90° flexion. A low-frequency ultrasound probe was positioned in the popliteal crease, and the needle was inserted from medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur. The tip of the needle was placed 1-2 cm beyond the lateral edge of the artery, and 20 ml of 0.2% ropivacaine was injected for each side. A ACB was done postoperatively with 20 ml ropivacaine 0.2% and a catheter was kept for 48H with 4 ml/h saline

Outcomes

Primary Outcome Measures

Morphine consumption
total Morphine consumption

Secondary Outcome Measures

Pain score at rest
numerical rating scale [0=no pain ; 10=worste pain]
Pain score during mouvment
numerical rating scale
Ambulation distance
number of steps walked by the patient
Chronic pain
DN4 score [0=minimum to 10= worste score]
functional status
KOOS PS score [0=minimum to 28= worste score]

Full Information

First Posted
February 24, 2020
Last Updated
June 16, 2020
Sponsor
University Tunis El Manar
Collaborators
Institut Kassab d'Orthopédie
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1. Study Identification

Unique Protocol Identification Number
NCT04295421
Brief Title
IPACK Block After Total Knee Arthroplasty
Official Title
Comparison of Adductor Canal Block and IPACK Block With Adductor Canal Block Alone After Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 31, 2020 (Actual)
Primary Completion Date
March 30, 2022 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Tunis El Manar
Collaborators
Institut Kassab d'Orthopédie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Adductor canal block (ACB) is a peripheral nerve blockade technique that provides good pain control in patients undergoing total knee arthroplasty (TKA) which however does not relieve posterior knee pain. The recent technique of an ultrasound-guided local anesthetic infiltration of the interspace between popliteal artery and the capsule of posterior knee (IPACK) has shown promising results in providing significant posterior knee analgesia without affecting the motor nerves. The hypothesis was that the combination of ACB + IPACK will provide better pain relief and improve knee function in the immediate postoperative period compared to ACB alone.
Detailed Description
This is a prospective, randomized and double blinded study All patients received : Pregabalin 150 mg preoperatively 12 h before the surgery. Single-shot spinal anesthesia with 10 to 12 mg of bupivacaine 0.5% and 2.5ug sufentanil patients were randomly allocated to receive: Group 1: IPACK + ACB single shoot Group 2: contineous ACB For group 1: IPACK was realized after spinal anesthesia with 40 ml ropivacaine 0.2% All patients received ACB in the immediate postoperative period with 20 ml ropivacaine 0.2% Post operative analgesia included: Paracetamol 1g IV every 6 hours Diclofenac sodium (50mg) 1 tablet x 2 per day Pregabalin 150 mg given orally once daily for a period of 4 weeks. PCA morphine (Patient Controlled Analgesia), as a rescue analgesia, Continuous ACB catheter for 48H with : 4 ml per hour 0.2% ropivacaine in group 2 4 ml per hour saline in group 1

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthropathy, Postoperative Pain
Keywords
knee arthoplasty, nerve block, analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Canal adductor block
Arm Type
Active Comparator
Arm Description
ACB was done in the immediate postoperative period under a high-frequency ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.2% ropivacaine was injected in the canal using a 22-gauge 100-mm short-beveled regional block needle and a catheter was kept for 48H with 4 ml/h ropivacaine 0.2%.
Arm Title
IPACK block
Arm Type
Experimental
Arm Description
IPACK was realized after spinal anesthesia. Patient was placed in a supine position and knee placed in position of 90° flexion. A low-frequency ultrasound probe was positioned in the popliteal crease, and the needle was inserted from medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur. The tip of the needle was placed 1-2 cm beyond the lateral edge of the artery, and 20 ml of 0.2% ropivacaine was injected for each side. A ACB was done postoperatively with 20 ml ropivacaine 0.2% and a catheter was kept for 48H with 4 ml/h saline
Intervention Type
Procedure
Intervention Name(s)
adductor canal block
Intervention Description
ACB was done in the immediate postoperative period under a high-frequency ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.2% ropivacaine was injected in the canal using a 22-gauge 100-mm short-beveled regional block needle and a catheter was kept for 48H with 4 ml/h ropivacaine 0.2%.
Intervention Type
Procedure
Intervention Name(s)
IPACK block
Intervention Description
IPACK block was realized after spinal anesthesia with 40 ml 0.2% ropivacaine and at the end of surgery , patients were given ACB with 20 ml 0.2% ropivacaine and continued with 4 ml/H saline for 48H
Primary Outcome Measure Information:
Title
Morphine consumption
Description
total Morphine consumption
Time Frame
Day 2
Secondary Outcome Measure Information:
Title
Pain score at rest
Description
numerical rating scale [0=no pain ; 10=worste pain]
Time Frame
Day 2
Title
Pain score during mouvment
Description
numerical rating scale
Time Frame
Day 2 [0=no pain ; 10=worste pain]
Title
Ambulation distance
Description
number of steps walked by the patient
Time Frame
Day 2
Title
Chronic pain
Description
DN4 score [0=minimum to 10= worste score]
Time Frame
Month 6
Title
functional status
Description
KOOS PS score [0=minimum to 28= worste score]
Time Frame
Month 6

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary total knee arthroplasty under spinal anesthesia Exclusion Criteria: Contraindication or refusal to regional anesthesia Contraindication to non steroidal anti inflammatory (NSAID's) Allergy to opioids Allergy to paracetamol Creatinine clearance < 30ml/min Weight<50 kg or >100kg
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olfa kaabachi, MD
Phone
+21698317381
Email
olfa.kaabachi@gnet.tn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
khaireddine Raddaoui, MD
Organizational Affiliation
Tunis El Manar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Kassab D'Orthopedie
City
Tunis
ZIP/Postal Code
2010
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olfa kaabachi, MD
Phone
98317381

12. IPD Sharing Statement

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IPACK Block After Total Knee Arthroplasty

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