Epidural Analgesia vs Adductor Canal Block in Bilateral TKA

NCT ID: NCT03205540

Last Updated: 2021-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2021-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteo Arthritis Knee

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Epidural analgesia

Lumbar continuous epidural block

Group Type EXPERIMENTAL

Continuous epidural block

Intervention Type PROCEDURE

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.

Bilateral ACB

Ultrasound-guided bilateral adductor canal blocks

Group Type EXPERIMENTAL

Bilateral single-shot bilateral adductor canal blocks

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Suwimon Tangwiwat

Assistant professor, Anesthesiology department, Faculty of Medicine Siriraj Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Suwimon Tangwiwat, MD

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Thailand

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 22146199 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12917945 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22221014 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27592218 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18211990 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Si 245/2017

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.