Epidural Analgesia vs Adductor Canal Block in Bilateral TKA

May 25, 2021 updated by: Suwimon Tangwiwat, Mahidol University

Comparison Efficacy of Analgesic Techniques: Continuous Epidural Analgesia Versus Bilateral Single-shot Adductor Canal Blocks in Patients Undergoing Bilateral Total Knee Arthroplasty

This study evaluates postoperative analgesic efficacy within 48 hours between epidural analgesia and single-shot bilateral adductor canal blocks in bilateral total knee arthroplasty. Half of participants will be received continuous epidural analgesia, while other half of participants will be received single-shot bilateral adductor canal blocks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Continuous epidural analgesia is effective postoperative pain control but it has some limitations in patients with hypotension, concurrent anticoagulants, technical difficulty, urinary retention.

Adductor canal block is less invasive than continuous epidural analgesia. It provides effective analgesia for total knee arthroplasty and preserves quadriceps muscle strength.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

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

  • Thailand
      • Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital, Mahidol University

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged more than 18 years old undergoing bilateral total knee arthroplasty
  • American Society of Anesthesiologists physical status classification 1-3

Exclusion Criteria:

  • Participants deny to enroll the study
  • Allergy to bupivacaine
  • Weight less than 50 kilograms
  • Hepatic disease
  • Contraincation for neuraxial block or adductor canal block
  • Uncontrolled cardiovascular disease
  • Creatinine clearance less than 50 ml/min

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
Experimental: Epidural analgesia
Lumbar continuous epidural block
Procedure: Continuous epidural block
Continuous epidural block at level L2-3 or L3-4 with 0.0625% bupivacaine + fentanyl 2 mcg/ml infusion epidurally 5 ml/hr for 48 hours postoperatively.
Experimental: Bilateral ACB
Ultrasound-guided bilateral adductor canal blocks
Procedure: Bilateral single-shot bilateral adductor canal blocks
Bilateral single-shot adductor canal blocks, ultrasound guidance, with 0.33% bupivacaine 15 ml on each side.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain scores at rests
Time Frame: 48 hours postoperatively
numerical rating scales
48 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
morphine consumptions
Time Frame: 48 hours postoperatively
total miligrams of morphine use in each arm
48 hours postoperatively
pain scores on movement
Time Frame: 48 hours postoperatively
numerical rating scales
48 hours postoperatively
side effects of interventions
Time Frame: 48 hours postoperatively
nausea vomiting hypotension
48 hours postoperatively

Collaborators and Investigators

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

Sponsor

Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 1, 2017

Primary Completion (Actual)

January 30, 2021

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

June 29, 2017

First Submitted That Met QC Criteria

June 29, 2017

First Posted (Actual)

July 2, 2017

Study Record Updates

Last Update Posted (Actual)

May 26, 2021

Last Update Submitted That Met QC Criteria

May 25, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si 245/2017

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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