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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04968392
Other study ID # 17300626
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date March 1, 2019
Est. completion date May 1, 2020

Study information

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

Clinical Trial Summary

Total knee arthroplasty surgery is associated with severe postoperative pain and adequate pain management is necessary for early postoperative mobilization and rehabilitation. Although good postoperative pain control may be achieved by continuous epidural anesthesia or femoral nerve block, both methods have adverse effects such as muscle weakness, which may delay postoperative mobilization.


Description:

The adductor canal block (ACB) is a relatively new block providing analgesia for knee surgery, which not only blocks the largest sensory branch of the femoral nerve but also results in less reduction of quadriceps muscle strength, compared with the femoral nerve block (FNB) in adult patients. Randomized controlled trials have revealed that ACB provides at least equal analgesia as FNB, preserves quadriceps muscle strength better than FNB, and thus allowing for functional recovery within the first 24-hour post-TKA. However, one important limitation of single-shot peripheral nerve block is the short duration of analgesia. Because the average duration of severe pain after TKA takes 2-3 days, a continuous ACB via catheter would seem to be a good choice. Unfortunately, perineural catheters may be technically difficult to insert, are prone to premature dislodgement, and may increase infection risk. There also were some case reports of local anesthetic-induced myotoxicity after continuous ACB.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 1, 2020
Est. primary completion date February 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - ASA physical status I or II - undergoing elective primary total knee arthroplasty surgery under spinal anesthesia. Exclusion Criteria: - Patients with a known history of significant hepatic, - renal, heart disease, autoimmune disease, - any known convulsive disorder, any psychiatric disorders, chronic pain, - pregnant females, regular use analgesics, anti-depressants, or opioids in the previous 2 months, revision surgery, morbid obesity, allergy to local anesthetics or morphine

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine Hydrochloride
20 mL of 0.25% levobupivacaine plus 0.5 µg/kg dexmedetomidine
Levobupivacaine
20 mL of 0.25% levobupivacaine plus 1 mL normal saline

Locations

Country Name City State
Egypt Assiut governorate Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Bauer MC, Pogatzki-Zahn EM, Zahn PK. Regional analgesia techniques for total knee replacement. Curr Opin Anaesthesiol. 2014 Oct;27(5):501-6. doi: 10.1097/ACO.0000000000000115. Review. — View Citation

Jæger P, Koscielniak-Nielsen ZJ, Schrøder HM, Mathiesen O, Henningsen MH, Lund J, Jenstrup MT, Dahl JB. Adductor canal block for postoperative pain treatment after revision knee arthroplasty: a blinded, randomized, placebo-controlled study. PLoS One. 2014 Nov 11;9(11):e111951. doi: 10.1371/journal.pone.0111951. eCollection 2014. — View Citation

Jiang X, Wang QQ, Wu CA, Tian W. Analgesic Efficacy of Adductor Canal Block in Total Knee Arthroplasty: A Meta-analysis and Systematic Review. Orthop Surg. 2016 Aug;8(3):294-300. doi: 10.1111/os.12268. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary the first analgesia rescue call. time to the first analgesic request. 24 hours postoperative
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