Single-shot Adductor Canal Block With Levobupivacaine and Dexmedetomidine in Total Knee Arthroplasty

NCT ID: NCT04968392

Last Updated: 2021-07-20

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-05-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Adductor Canal Block Levobupivacaine Dexmedetomidine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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L group

20 mL of 0.25% levobupivacaine plus 1 mL normal saline

Group Type EXPERIMENTAL

Levobupivacaine

Intervention Type DRUG

20 mL of 0.25% levobupivacaine plus 1 mL normal saline

LD group

20 mL of 0.25% levobupivacaine plus 0.5 µg/kg dexmedetomidine

Group Type EXPERIMENTAL

Dexmedetomidine Hydrochloride

Intervention Type DRUG

20 mL of 0.25% levobupivacaine plus 0.5 µg/kg dexmedetomidine

Interventions

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Dexmedetomidine Hydrochloride

20 mL of 0.25% levobupivacaine plus 0.5 µg/kg dexmedetomidine

Intervention Type DRUG

Levobupivacaine

20 mL of 0.25% levobupivacaine plus 1 mL normal saline

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ghada Mohammed AboelFadl

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut governorate

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 25111605 (View on PubMed)

Jaeger P, Koscielniak-Nielsen ZJ, Schroder 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.

Reference Type BACKGROUND
PMID: 25386752 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27627711 (View on PubMed)

Other Identifiers

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17300626

Identifier Type: -

Identifier Source: org_study_id

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