NCT03733509

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

November 12, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2022

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

3.5 years

First QC Date

November 6, 2018

Last Update Submit

October 25, 2022

Conditions

Knee OsteoarthritisTotal Knee ArthroplastyNerve Block

Outcome Measures

Primary Outcomes (1)

  • 24 hour opioid consumption

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

    First 24 hours after surgery

Secondary Outcomes (4)

  • 24 patient reported pain

    First 24 hours after surgery

  • Time up and go Test

    24 hours after surgery

  • Time to Discharge

    7 days

  • Range of motion

    24 hours after surgery

Study Arms (2)

Intraoperative Block

EXPERIMENTAL

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%).

Procedure: Intraoperative BlockProcedure: Ultrasound Placebo

Ultrasound Block

ACTIVE COMPARATOR

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%.

Procedure: Ultrasound BlockProcedure: Intraoperative Placebo

Interventions

Intraoperative BlockPROCEDURE

One shot adductor canal nerve block with 20ml of bupivacaine 0.25% through surgical incision

Intraoperative Block
Ultrasound BlockPROCEDURE

One shot adductor canal nerve block with 20ml of bupivacaine 0.25% mid-thigh

Ultrasound Block
Intraoperative PlaceboPROCEDURE

One shot adductor canal nerve infusion with 20ml of saline solution through surgical incision

Ultrasound Block
Ultrasound PlaceboPROCEDURE

One shot adductor canal nerve infusion with 20ml of saline solution mid-thigh

Intraoperative Block

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, 8330024, Chile

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Pablo Besa

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two arm, randomly assigned
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2018

First Posted

November 7, 2018

Study Start

November 12, 2018

Primary Completion

May 12, 2022

Study Completion

October 24, 2022

Last Updated

October 26, 2022

Record last verified: 2022-10

Locations

CL(1)