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Epidural Analgesia vs Adductor Canal Block in Bilateral TKA

Primary Purpose

Osteo Arthritis Knee

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Continuous epidural block

Bilateral single-shot bilateral adductor canal blocks

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring Continuous epidural analgesia, Bilateral single-shot adductor canal blocks

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Faculty of Medicine Siriraj Hospital, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Epidural analgesia

Bilateral ACB

Arm Description

Lumbar continuous epidural block

Ultrasound-guided bilateral adductor canal blocks

Outcomes

Primary Outcome Measures

pain scores at rests

numerical rating scales

Secondary Outcome Measures

morphine consumptions

total miligrams of morphine use in each arm

pain scores on movement

numerical rating scales

side effects of interventions

nausea vomiting hypotension

Full Information

NCT ID

NCT03205540

First Posted

June 29, 2017

Last Updated

May 25, 2021

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT03205540

Brief Title

Epidural Analgesia vs Adductor Canal Block in Bilateral TKA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

August 1, 2017 (Actual)

Primary Completion Date

January 30, 2021 (Actual)

Study Completion Date

May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteo Arthritis Knee

Keywords

Continuous epidural analgesia, Bilateral single-shot adductor canal blocks

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Epidural analgesia

Arm Type

Experimental

Arm Description

Lumbar continuous epidural block

Arm Title

Bilateral ACB

Arm Type

Experimental

Arm Description

Ultrasound-guided bilateral adductor canal blocks

Intervention Type

Procedure

Intervention Name(s)

Continuous epidural block

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Bilateral single-shot bilateral adductor canal blocks

Intervention Description

Bilateral single-shot adductor canal blocks, ultrasound guidance, with 0.33% bupivacaine 15 ml on each side.

Primary Outcome Measure Information:

Title

pain scores at rests

Description

numerical rating scales

Time Frame

48 hours postoperatively

Secondary Outcome Measure Information:

Title

morphine consumptions

Description

total miligrams of morphine use in each arm

Time Frame

48 hours postoperatively

Title

pain scores on movement

Description

numerical rating scales

Time Frame

48 hours postoperatively

Title

side effects of interventions

Description

nausea vomiting hypotension

Time Frame

48 hours postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suwimon Tangwiwat, MD

Organizational Affiliation

Faculty of Medicine Siriraj Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Medicine Siriraj Hospital, Mahidol University

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

22146199

Citation

Dimitris CN, Taylor BC, Mowbray JG, Steensen RN, Gaines ST. Perioperative morbidity and mortality of 2-team simultaneous bilateral total knee arthroplasty. Orthopedics. 2011 Dec 6;34(12):e841-6. doi: 10.3928/01477447-20111021-02.

Results Reference

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PubMed Identifier

12917945

Citation

Choi PT, Bhandari M, Scott J, Douketis J. Epidural analgesia for pain relief following hip or knee replacement. Cochrane Database Syst Rev. 2003;(3):CD003071. doi: 10.1002/14651858.CD003071.

Results Reference

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PubMed Identifier

22221014

Citation

Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.

Results Reference

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PubMed Identifier

27592218

Citation

Gerrard AD, Brooks B, Asaad P, Hajibandeh S, Hajibandeh S. Meta-analysis of epidural analgesia versus peripheral nerve blockade after total knee joint replacement. Eur J Orthop Surg Traumatol. 2017 Jan;27(1):61-72. doi: 10.1007/s00590-016-1846-z. Epub 2016 Sep 3.

Results Reference

background

PubMed Identifier

18211990

Citation

Fowler SJ, Symons J, Sabato S, Myles PS. Epidural analgesia compared with peripheral nerve blockade after major knee surgery: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2008 Feb;100(2):154-64. doi: 10.1093/bja/aem373.

Results Reference

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Epidural Analgesia vs Adductor Canal Block in Bilateral TKA

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