NCT04286035

Brief Summary

The frequency of femoral nerve block and adductor canal block for analgesia after TKA(total knee arthroplasty) increases with the use of ultrasonography in regional anesthesia. In this study, we aimed to compare the effects of femoral nerve block and adductor canal block on postoperative analgesia in patients undergoing unilateral knee arthroplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2019

Shorter than P25 for phase_4

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

April 2, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2019

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
Last Updated

March 13, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

February 21, 2020

Last Update Submit

March 11, 2020

Conditions

Keywords

femoral nerve block, adductor canal block, total knee arthroplasty

Outcome Measures

Primary Outcomes (3)

  • Tramadol consumption

    Postoperative tramadol consumption with patient controlled analgesia

    24 hours after operation

  • VAS(visual analogue scale) score (0-10, 0 is no pain, 10 is the most severe pain)

    VAS(visual analogue scale) score (0-10, 0 is no pain, 10 is the most severe pain) is less than four is adequate analgesia

    24 hours after operation

  • Rescue analgesic requirement

    If VAS(visual analogue scale) score (0-10, 0 is no pain, 10 is the most severe pain) is is four or more, paracetamol 1000 mg is administered

    24 hours after operation

Secondary Outcomes (1)

  • Postoperative nausea and vomiting

    24 hours after operation

Study Arms (2)

Femoral group

ACTIVE COMPARATOR
Drug: Bupivacaine Injection

Adductor group

ACTIVE COMPARATOR
Drug: Bupivacaine Injection

Interventions

Femoral nerve block with 20 ml %0.375 bupivacaine

Femoral group

Eligibility Criteria

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

You may qualify if:

  • ASA(American Society of Anesthesiologists) Classification I-II
  • Age: \<55 years
  • Unilateral total knee arthroplasty

You may not qualify if:

  • Does not approve the study
  • Pregnant
  • Emergency
  • ASA III-IV
  • History of local anesthetic allergy
  • Infection in the block area
  • Coagulation disorder
  • Morbid obesity (body mass index\> 40 kg / m²)
  • Severe organ failure
  • Previous neurological deficit
  • Psychiatric disease
  • History of chronic pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SBÜ Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

February 21, 2020

First Posted

February 26, 2020

Study Start

April 2, 2019

Primary Completion

September 29, 2019

Study Completion

October 1, 2019

Last Updated

March 13, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations