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Intraoperative Direct vs Postoperative Ultrasound Guided Adductor Canal Nerve Block After Total Knee Arthroplasty

Primary Purpose

Knee Osteoarthritis, Total Knee Arthroplasty, Nerve Block

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Intraoperative Block
Ultrasound Block
Intraoperative Placebo
Ultrasound Placebo
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

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

Inclusion Criteria:

  • Primary total knee arthroplasty
  • Unilateral
  • American Society of Anesthesiologists (ASA) score I, II or III
  • Accepts spinal anesthesia

Exclusion Criteria:

  • General anesthesia
  • Chronic kidney disease
  • Drug or alcohol abuse
  • Chronic opioid use
  • Allergic to bupivacaine or similar

Sites / Locations

  • Pontificia Universidad Católica de Chile

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intraoperative Block

Ultrasound Block

Arm Description

Before skin closure, blunt suprapatellar dissection proximal to medial femoral condyle towards adductor canal. Nerve block at this level with 20ml of Bupivacaine 0.25%. Postoperatively, mid-thigh ultrasound guided standard adductor canal nerve block with 20ml of saline solution (NaCl 0.9%).

Before skin closure, blunt suprapatellar dissection proximal to medial femoral condyle towards adductor canal. Nerve block at this level with 20ml of of saline solution (NaCl 0.9%). Postoperatively, mid-thigh ultrasound guided standard adductor canal nerve block with 20ml Bupivacaine 0.25%.

Outcomes

Primary Outcome Measures

24 hour opioid consumption
Opioid consumption by patient controlled analgesia (PCA) and any other oral or IV analgesics

Secondary Outcome Measures

24 patient reported pain
Patient reported pain scale using visual analog scale (VAS) every 6 hours after surgery (0 hours, 6 hours, 12 hours, 18 hours and 24 hours)
Time up and go Test
Standardised test to determine patients ability to walk 24 hours after surgery
Time to Discharge
Time between surgery and patient in conditions for discharge: no IV requirements, basic walking capability and VAS pain score equal or below 3
Range of motion
Active and passive knee range of motion

Full Information

First Posted
November 6, 2018
Last Updated
October 25, 2022
Sponsor
Pontificia Universidad Catolica de Chile
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1. Study Identification

Unique Protocol Identification Number
NCT03733509
Brief Title
Intraoperative Direct vs Postoperative Ultrasound Guided Adductor Canal Nerve Block After Total Knee Arthroplasty
Official Title
Intraoperative Direct Adductor Canal Nerve Block Versus Post Operative Ultrasound Guided Adductor Canal Nerve Block in Total Knee Arthroplasty: a Double-blind Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 12, 2018 (Actual)
Primary Completion Date
May 12, 2022 (Actual)
Study Completion Date
October 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pontificia Universidad Catolica de Chile

4. Oversight

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

5. Study Description

Brief Summary
This study compares analgesic effect between two techniques of adductor canal nerve block after total knee arthroplasty. The first group of the patients will receive intraoperative adductor canal nerve block; and the other group post operative ultrasound guided adductor canal nerve block. Investigators will measure postoperative opioid consumption, pain management and rehabilitation goals.
Detailed Description
Total knee arthroplasty (TKA) is a successful alternative to treat late stage knee osteoarthritis (OA). Pain management has been one of the main focuses of postoperative care. Most surgeons prefer a comprehensive multimodal approach including preoperative pharmacological treatment, intraoperative infiltration with complex drug mixes and postoperative peripheral nerve block. The most common postoperative nerve block alternative is the proximal femoral nerve block (FNB) which has shown improvements on postoperative pain measured by reduced opioid consumption and decreased pain at rest. Its main detractors argue that the motor nerve block effect is deleterious to early ambulation and have promoted adductor canal nerve blocks (ACB). Described by Lund et al in 2011, ACB block main femoral pain sensory contributors to the knee (articular branches of obturator nerve, vastus medialis branch and saphenous nerve) but is more distal to most motor branches to the quadriceps allowing near to normal quadriceps strength. Standard ACB block is performed under ultrasound guidance after surgery completion, still in the operating room (OR). Recent literature has shown the anatomic feasibility of intraoperative ACB via blunt suprapatellar dissection in standard medial parapatellar TKA approaches. The study seeks to determine the effectiveness of standard ultrasound guidance ACB compared with intraoperative ACB.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Total Knee Arthroplasty, Nerve Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two arm, randomly assigned
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Total blind (patient, physicians, outcome assessors and statistician) Closed envelope by independent randomizer is given to physician assistant. The assistant prepares randomly allocated placebo or local anesthetic. Group is coded so that statistician is also blind
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intraoperative Block
Arm Type
Experimental
Arm Description
Before skin closure, blunt suprapatellar dissection proximal to medial femoral condyle towards adductor canal. Nerve block at this level with 20ml of Bupivacaine 0.25%. Postoperatively, mid-thigh ultrasound guided standard adductor canal nerve block with 20ml of saline solution (NaCl 0.9%).
Arm Title
Ultrasound Block
Arm Type
Active Comparator
Arm Description
Before skin closure, blunt suprapatellar dissection proximal to medial femoral condyle towards adductor canal. Nerve block at this level with 20ml of of saline solution (NaCl 0.9%). Postoperatively, mid-thigh ultrasound guided standard adductor canal nerve block with 20ml Bupivacaine 0.25%.
Intervention Type
Procedure
Intervention Name(s)
Intraoperative Block
Intervention Description
One shot adductor canal nerve block with 20ml of bupivacaine 0.25% through surgical incision
Intervention Type
Procedure
Intervention Name(s)
Ultrasound Block
Intervention Description
One shot adductor canal nerve block with 20ml of bupivacaine 0.25% mid-thigh
Intervention Type
Procedure
Intervention Name(s)
Intraoperative Placebo
Intervention Description
One shot adductor canal nerve infusion with 20ml of saline solution through surgical incision
Intervention Type
Procedure
Intervention Name(s)
Ultrasound Placebo
Intervention Description
One shot adductor canal nerve infusion with 20ml of saline solution mid-thigh
Primary Outcome Measure Information:
Title
24 hour opioid consumption
Description
Opioid consumption by patient controlled analgesia (PCA) and any other oral or IV analgesics
Time Frame
First 24 hours after surgery
Secondary Outcome Measure Information:
Title
24 patient reported pain
Description
Patient reported pain scale using visual analog scale (VAS) every 6 hours after surgery (0 hours, 6 hours, 12 hours, 18 hours and 24 hours)
Time Frame
First 24 hours after surgery
Title
Time up and go Test
Description
Standardised test to determine patients ability to walk 24 hours after surgery
Time Frame
24 hours after surgery
Title
Time to Discharge
Description
Time between surgery and patient in conditions for discharge: no IV requirements, basic walking capability and VAS pain score equal or below 3
Time Frame
7 days
Title
Range of motion
Description
Active and passive knee range of motion
Time Frame
24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary total knee arthroplasty Unilateral American Society of Anesthesiologists (ASA) score I, II or III Accepts spinal anesthesia Exclusion Criteria: General anesthesia Chronic kidney disease Drug or alcohol abuse Chronic opioid use Allergic to bupivacaine or similar
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Besa
Organizational Affiliation
Pontificia Universidad Catolica de Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pontificia Universidad Católica de Chile
City
Santiago
State/Province
Región Metropolitana
ZIP/Postal Code
8330024
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Intraoperative Direct vs Postoperative Ultrasound Guided Adductor Canal Nerve Block After Total Knee Arthroplasty

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