NCT03205540

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

May 26, 2021

Status Verified

May 1, 2021

Enrollment Period

3.5 years

First QC Date

June 29, 2017

Last Update Submit

May 25, 2021

Conditions

Osteo Arthritis Knee

Keywords

Continuous epidural analgesiaBilateral single-shot adductor canal blocks

Outcome Measures

Primary Outcomes (1)

  • pain scores at rests

    numerical rating scales

    48 hours postoperatively

Secondary Outcomes (3)

  • morphine consumptions

    48 hours postoperatively

  • pain scores on movement

    48 hours postoperatively

  • side effects of interventions

    48 hours postoperatively

Study Arms (2)

Epidural analgesia

EXPERIMENTAL

Lumbar continuous epidural block

Procedure: Continuous epidural block

Bilateral ACB

EXPERIMENTAL

Ultrasound-guided bilateral adductor canal blocks

Procedure: Bilateral single-shot bilateral adductor canal blocks

Interventions

Continuous epidural blockPROCEDURE

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.

Epidural analgesia
Bilateral single-shot bilateral adductor canal blocksPROCEDURE

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

Bilateral ACB

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

Related Publications (5)

  • 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.

    PMID: 22146199BACKGROUND

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

    PMID: 12917945BACKGROUND

  • 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.

    PMID: 22221014BACKGROUND

  • 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.

    PMID: 27592218BACKGROUND

  • 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.

    PMID: 18211990BACKGROUND

Study Officials

  • Suwimon Tangwiwat, MD

    Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor, Anesthesiology department, Faculty of Medicine Siriraj Hospital

Study Record Dates

First Submitted

June 29, 2017

First Posted

July 2, 2017

Study Start

August 1, 2017

Primary Completion

January 30, 2021

Study Completion

May 1, 2021

Last Updated

May 26, 2021

Record last verified: 2021-05

Locations

TH(1)