Osteo Arthritis Knee Clinical Trial
Official title:
Comparison Efficacy of Analgesic Techniques: Continuous Epidural Analgesia Versus Bilateral Single-shot Adductor Canal Blocks in Patients Undergoing Bilateral Total Knee Arthroplasty
| 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 |
| Verified date | May 2021 |
| Source | Mahidol University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Faculty of Medicine Siriraj Hospital, Mahidol University | Bangkok |
| Lead Sponsor | Collaborator |
|---|---|
| Mahidol University |
Thailand,
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
| 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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