Two Different Blocks for Postoperative Analgesia in Patients Undergoing Unilateral Total Knee Arthroplasty

March 11, 2020 updated by: Kerim Şahin, Sisli Hamidiye Etfal Training and Research Hospital

Comparison of the Effects of Femoral Nerve Block and Adductor Canal Block on Postoperative Analgesia in Patients Undergoing Unilateral Total Knee Arthroplasty

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • SBÜ Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Femoral group
Drug: Bupivacaine Injection
Femoral nerve block with 20 ml %0.375 bupivacaine
Drug: Bupivacaine Injection
Adductor canal block with 20 ml %0.375 bupivacaine
Active Comparator: Adductor group
Drug: Bupivacaine Injection
Femoral nerve block with 20 ml %0.375 bupivacaine
Drug: Bupivacaine Injection
Adductor canal block with 20 ml %0.375 bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tramadol consumption
Time Frame: 24 hours after operation
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)
Time Frame: 24 hours after operation
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
Time Frame: 24 hours after operation
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative nausea and vomiting
Time Frame: 24 hours after operation
Frequency of postoperative nausea and vomiting
24 hours after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2019

Primary Completion (Actual)

September 29, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

February 21, 2020

First Submitted That Met QC Criteria

February 24, 2020

First Posted (Actual)

February 26, 2020

Study Record Updates

Last Update Posted (Actual)

March 13, 2020

Last Update Submitted That Met QC Criteria

March 11, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SK01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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