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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03205540
Other study ID # Si 245/2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2017
Est. completion date May 1, 2021

Study information

Verified date May 2021
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date May 1, 2021
Est. primary completion date January 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Thailand Faculty of Medicine Siriraj Hospital, Mahidol University Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (5)

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. Review. — View 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. — View 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. Review. — View 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. Review. — View Citation

Jenstrup MT, Jæger 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary pain scores at rests numerical rating scales 48 hours postoperatively
Secondary morphine consumptions total miligrams of morphine use in each arm 48 hours postoperatively
Secondary pain scores on movement numerical rating scales 48 hours postoperatively
Secondary side effects of interventions nausea vomiting hypotension 48 hours postoperatively
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