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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03733509
Other study ID # 180620002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 12, 2018
Est. completion date October 24, 2022

Study information

Verified date October 2022
Source Pontificia Universidad Catolica de Chile
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 121
Est. completion date October 24, 2022
Est. primary completion date May 12, 2022
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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

Study Design


Intervention

Procedure:
Intraoperative Block
One shot adductor canal nerve block with 20ml of bupivacaine 0.25% through surgical incision
Ultrasound Block
One shot adductor canal nerve block with 20ml of bupivacaine 0.25% mid-thigh
Intraoperative Placebo
One shot adductor canal nerve infusion with 20ml of saline solution through surgical incision
Ultrasound Placebo
One shot adductor canal nerve infusion with 20ml of saline solution mid-thigh

Locations

Country Name City State
Chile Pontificia Universidad Católica de Chile Santiago Región Metropolitana

Sponsors (1)

Lead Sponsor Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type Measure Description Time frame Safety issue
Primary 24 hour opioid consumption Opioid consumption by patient controlled analgesia (PCA) and any other oral or IV analgesics First 24 hours after surgery
Secondary 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) First 24 hours after surgery
Secondary Time up and go Test Standardised test to determine patients ability to walk 24 hours after surgery 24 hours after surgery
Secondary 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 7 days
Secondary Range of motion Active and passive knee range of motion 24 hours after surgery
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