NCT05613101

Brief Summary

Total knee arthroplasty surgery is preferred in the treatment of osteoarthritis and causes severe postoperative pain. In this study, we aimed to investigate the effects of lumbar erector spina plan block and adductor canal block on postoperative pain and quadriceps muscle strength in patients who underwent total knee arthroplasty with spinal anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

December 15, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 6, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

October 6, 2022

Last Update Submit

November 10, 2022

Conditions

Keywords

Erector Spinae Plane BlockAdductor Canal BlockTotal Knee Arthroplasty

Outcome Measures

Primary Outcomes (8)

  • Postoperative pain 30 minute

    Visual anolog score (1-10)

    30. min.

  • Postoperative pain 1. hour

    Visual anolog score (1-10)

    1. hour

  • Postoperative pain 2. hour

    Visual anolog score (1-10)

    2. hour

  • Postoperative pain 6. hour

    Visual anolog score (1-10)

    6. hour

  • Postoperative pain 12. hour

    Visual anolog score (1-10)

    12. hour

  • Postoperative pain 24. hour

    Visual anolog score (1-10)

    24. hour

  • Postoperative pain 36. hour

    Visual anolog score (1-10)

    36. hour

  • Postoperative pain 48. hour

    Visual anolog score (1-10)

    48. hour

Secondary Outcomes (8)

  • Opioid consuption 30. min.

    30. min.

  • Opioid consuption 1. hour

    1. hour

  • Opioid consuption 2. hour

    2. hour

  • Opioid consuption 6. hour

    6. hour

  • Opioid consuption 12. hour

    12. hour

  • +3 more secondary outcomes

Study Arms (2)

Erector Spinae Plane Block

ACTIVE COMPARATOR

Erector Spina Plane Block was performed to the patients after coplition of total knee arthroplasty operation for postopetaive pain.

Procedure: Erector Spinae Plane Block

Adductor Canal Block

ACTIVE COMPARATOR

Adductor Canal Block was performed to the patients after coplition of total knee arthroplasty operation for postopetaive pain.

Procedure: Adductor Canal Block

Interventions

After the necessary asepsis and antisepsis procedures, the linear ultrasound probe was placed parasagittally 2-3 cm lateral to the spinous process at the L3 or L4 level and the transverse process was visualized. The peripheral block needle (85 mm B Braun Stimuplex A) was advanced in plane up to the transverse process and 10 ml 0.5% bupivacaine hydrochloride 10 ml 0.9% isotonic NaCl mixture was applied on the erector spina muscle.

Erector Spinae Plane Block

After the necessary asepsis and antisepsis procedures, the linear ultrasound probe was placed in the middle between the medial condyle and the SIAS, and the superficial femoral artery (FSA) was visualized under the sartorius muscle. By following the FSA distally, the point where the sartorius muscle crosses the adductor magnus muscle, which is the beginning of the adductor canal, was found and the saphenous nerve was visualized hyperechoic in the anterolateral aspect of the FSA. 20 cc 0.5% bupivacaine hydrochloride was applied

Adductor Canal Block

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who underwent total knee arthroplasty surgery
  • ASA I-III patients

You may not qualify if:

  • Patients with coagulopathy
  • Patients history with local anesthetic allergy or toxicity
  • Patients with long hospital stay
  • Patients with advanced organ failure
  • Mental retarded patients
  • Presence of infection at the injection site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University Goztepe Suleyman Yalcın City Hospital

Istanbul, 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
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Erector Plane Block Adductor Canal Block
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

October 6, 2022

First Posted

November 14, 2022

Study Start

December 15, 2021

Primary Completion

June 15, 2022

Study Completion

August 30, 2022

Last Updated

November 14, 2022

Record last verified: 2022-11

Locations