NCT04968392

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

11 months

First QC Date

July 4, 2021

Last Update Submit

July 8, 2021

Conditions

Adductor Canal BlockLevobupivacaineDexmedetomidine

Keywords

DexmedetomidinelevobupivacaineAdductor Canal Block

Outcome Measures

Primary Outcomes (1)

  • the first analgesia rescue call.

    time to the first analgesic request.

    24 hours postoperative

Study Arms (2)

L group

EXPERIMENTAL

20 mL of 0.25% levobupivacaine plus 1 mL normal saline

Drug: Levobupivacaine

LD group

EXPERIMENTAL

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

Drug: Dexmedetomidine Hydrochloride

Interventions

Dexmedetomidine HydrochlorideDRUG

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

LD group
LevobupivacaineDRUG

20 mL of 0.25% levobupivacaine plus 1 mL normal saline

L group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA physical status I or II
  • undergoing elective primary total knee arthroplasty surgery under spinal anesthesia.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut governorate

Asyut, Egypt

Location

Related 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.

    PMID: 25111605BACKGROUND

  • 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.

    PMID: 25386752BACKGROUND

  • 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.

    PMID: 27627711BACKGROUND

MeSH Terms

Interventions

DexmedetomidineLevobupivacaine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 4, 2021

First Posted

July 20, 2021

Study Start

March 1, 2019

Primary Completion

February 1, 2020

Study Completion

May 1, 2020

Last Updated

July 20, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)