NCT03188809

Brief Summary

After total knee prosthesis surgery, in the first postopertive days, serious pain complaints occur in the patients and this causes many problems, especially mobility limitation. For this reason, a strong analgesic is needed. As a part of multimodal analgesia after total knee surgery, nerve blocks are frequently preferred. While central nerve blocks are preferred in the forefront, peripheral nerve blocks are frequently preferred due to complications related to central nerve blocks. Femoral nerve block and adductor channel block are the preferred peripheral blocks for total knee prosthesis. Since early mobilization after total hip prosthesis is very important, it is aimed to provide sufficient analgesia by making less motor block. Previous studies have shown that adductor channel block provides similar analgesia with femoral nerve block. Early mobilization, early discharge and the impact on the risk of falls are not yet clear, although it is estimated to be in the positive direction. Again, previous studies have compared single doses and infusion doses but no repeated bolus doses. Repeated bolus doses have been shown to be more effective in studies in which adductor channel catheters have been introduced to date to compare infusion and recurrent bolus doses. investigators aimed to compare the effects of repeated bolus doses with femoral nerve catheter and adductor channel catheter on postoperative pain and muscle strength in patients undergoing total knee replasment under spinal anesthesia in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Apr 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

April 5, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 15, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

9 months

First QC Date

April 4, 2017

Last Update Submit

March 17, 2024

Conditions

Keywords

Postoperative PainFunctional OutcomesTotal Knee ArthroplastyAdductor Canal BlockFemoral Nerve Block

Outcome Measures

Primary Outcomes (1)

  • Postoperative Muscle strength- Quadriceps Muscle strength scale

    Quadriceps Muscle strength scale

    postoperative 48 hour

Secondary Outcomes (1)

  • postoperative analgesia - Visual analog scale

    72 hour

Study Arms (2)

femoral nerve block

ACTIVE COMPARATOR

Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted.

Procedure: femoral nerve block

adductor canal block

ACTIVE COMPARATOR

Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted.

Procedure: Adductor Canal Block

Interventions

Adductor channel is roughly triangular in cross section and is bounded by three muscles: quadriceps anterolaterally (specifically vastusmedialis), sartorius medially and adductor magnus posteriorly. Within this canal is the femoral artery, femoral vein, the posterior branch of the obturator nerve, and branches of the femoral nerve; specifically the saphenous nerve and nerve to vastus medialis. When the femoral artery is shown by ultrasonography 21 gauge, 50 mm needle in-plane technique and the catheter will be inserted with the peripheral nerve stimulator lateral to the femoral artery. Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted.and the catheter will be inserted with the peripheral nerve stimulator lateral to the femoral artery. Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted.

Also known as: saphen nerve block
adductor canal block

The probe is placed just below the inguinal crease , when the femoral artery is shown by ultrasonography, the femoral nerve stays in the lateral direction and 21 gauge, 50 mm needle will be advanced from the anterior to the posteriomedial with an in-plane technique and the catheter will be inserted by the peripheral nerve stimulator in the lateral femoral artery. Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted.

femoral nerve block

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA1-2-3 patients
  • older than 55 years
  • who undergo elective total knee prosthesis in our hospital

You may not qualify if:

  • ASA IV patients ,
  • patients with local anesthesia that we use,
  • patients with coagulation disorders,
  • patients with anatomical anomalies,
  • patients with localized infection in the injection site ,
  • patients who is incapable of using pca and/ or evaulate VAS scale,
  • patients with peripheral nerve disease,
  • patients with different surgical planning,
  • complicated gonarthrosis patients,
  • revision planned patients,
  • patients who refuse to be involved in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SEDA

Ankara, Kecioren, 06380, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: double blind, randomised, controlled train
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

April 4, 2017

First Posted

June 15, 2017

Study Start

April 5, 2017

Primary Completion

December 30, 2017

Study Completion

December 31, 2017

Last Updated

March 19, 2024

Record last verified: 2024-03

Locations