UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040054 |
|---|---|
| Receipt number | R000045668 |
| Scientific Title | The efficacy of the popliteal plexus block for total knee arthroplasty; the comparison with the tibial nerve block |
| Date of disclosure of the study information | 2020/04/04 |
| Last modified on | 2023/04/13 22:25:38 |
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Basic information
Public title
The efficacy of the popliteal plexus block for total knee arthroplasty; the comparison with the tibial nerve block
Acronym
The efficacy of the popliteal plexus block for total knee arthroplasty; the comparison with the tibial nerve block
Scientific Title
The efficacy of the popliteal plexus block for total knee arthroplasty; the comparison with the tibial nerve block
Scientific Title:Acronym
The efficacy of the popliteal plexus block for total knee arthroplasty; the comparison with the tibial nerve block
Region
| Japan |
Condition
Condition
knee osteoarthritis or knee rheumatoid arthritis
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to clarify the equivalent or non-inferior efficacy of the early discharge after total knee arthroplasty using popliteal plexus block or tibial nerve block for the reduction of the dorsal aspect of the knee.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Early discharge readiness
2.
Key secondary outcomes
Postoperative pain score (NRS): Postoperative 1 hour, time point per 12 hours till postoperative 72 hours)
Postoperative motor function (24, 48, 72 hours)
Postoperative rehabilitation score and muscle power(24, 48, 72 hours)
Consumption of postoperative additional analgesics(72 hours)
Complication(72 hours)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Popliteal Plexus Block with 0.25% levobupivacaine 10 mL
Interventions/Control_2
Tibial Nerve Block(TNB) with 0.25% levobupivacaine 10 mL
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients scheduled unilateral total knee arthroplasty at Daiyukai General Hospital
2.Adults (>=20 years) with American Society of Anaesthesiologists Physical Status Classification I-III
3.Participants were scheduled for primary unilateral TKA for osteoarthritis
4.Written informed consent is provided
Key exclusion criteria
1.Inability to communicate lucidly
2.Bilateral TKA
3.revision knee arthroplasty
4.Under 20 years old
5.Allergy to any of the drugs used in this study
6.ASA-PS > III
7.Chronic opioid use
8.Diabetes mellitus with sensory disorders
9.Neurological disability
10.Infections around femoral crease
11.Platelet < 5.0 * 10^4 /mcl
12.Pregnancy, possibility of pregnancy, or breast-feeding women
13.Contraindications to peripheral nerve blocks
Target sample size
136
Research contact person
Name of lead principal investigator
| 1st name | Norihiro |
| Middle name | |
| Last name | Sakai |
Organization
Daiyukai General Hospital
Division name
Dep. Anaesthesiplogy
Zip code
491-8551
Address
1-9-9, Sakura, Ichinomiya, Aichi, Japan
TEL
+81-586-72-1211
sakayline@anes.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Norihiro |
| Middle name | |
| Last name | Sakai |
Organization
Daiyukai General Hospital
Division name
Dep. Anaesthesiplogy
Zip code
491-8551
Address
1-9-9, Sakura, Ichinomiya, Aichi, Japan
TEL
+81-586-72-1211
Homepage URL
http://www.wb.commufa.jp/dykmasui/
sakayline@anes.med.osaka-u.ac.jp
Sponsor or person
Institute
Daiyukai General Hospital
Institute
Department
Personal name
Funding Source
Organization
Daiyukai General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institution of Review Board of Daiyukai general Hospital
Address
1-9-9, Sakura, Ichinomiya, Aichi, Japan
Tel
+81-586-72-1211
extensor2@yahoo.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2020-001
Org. issuing International ID_1
Daiyukai General Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
総合大雄会病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 04 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045668
Publication of results
Published
Result
URL related to results and publications
now preparing
Number of participants that the trial has enrolled
132
Results
The discharge criteria durations were 49.7(10.5) and 47.4(9.7) hours in TNB and PPB groups, respectively, with a mean difference of -2.3 hours (95% CI: -5.8 to 1.2 hours; P = 0.20).
Results date posted
| 2023 | Year | 04 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
PPB TNB
Sample size, n 67 65
Patient characteristics
Gender, n (%)
Male 20 (29.9) 20 (30.8)
Female 47 (60.1) 45(69.2)
ASA status, n (%)
I 8 (11.9) 4 (6.2)
II 56 (83.6) 57 (87.6)
III 3 (4.5) 4 (6.2)
Left and Right, n (%)
Left 43 (64.1) 32 (49.2)
Right 24 (35.9) 33 (50.8)
Mean age (SD) in years 76 (8) 75 (7)
Mean height (SD) in cm 154 (6) 154 (10)
Mean weight (SD) in kg 60 (10) 60 (11)
Mean BMI (SD) in kg/m2 25.0 (3.3) 25.4 (3.5)
Preoperative knee flexion (SD), degree 126 (13) 123 (15)
Surgical values
Mean duration of surgery (SD) in minutes 114 (17) 115 (16)
Mean duration of operation room occupied (SD) in minutes 165 (19) 167 (19)
Mean duration of tourniquet ischemia (SD) in minutes 105 (13) 107 (11)
Mean bleeding (SD) in mL 129 (75) 114 (56)
mean water balance (SD) in mL 722 (267) 716 (241)
Participant flow
We included 136 patients with TKA meeting the inclusion criteria (Figure 1). Data from 132 patients were analyzed; 4 were excluded because of protocol violations during surgery, including 1 in the PPB group and 3 in the TNB group. The patient demographics of the groups were not significantly different (P > 0.05) (Table 1).
Adverse events
Postoperative nausea and vommiting 3/132
Falling 0/132
Pruitus 0/132
Outcome measures
The primary endpoint was the time to fulfill the discharge criteria of an NRS of under 4 at rest, 30-meter ambulation using a walker, and the ability to perform 90 degree knee flexion.4,6 The secondary endpoints included evaluating NRS scores at rest and during rehabilitation using supplementary analgesics, postoperative SLR test results at 1, 24, 48, and 72 hours, as well as the time required to achieve deep knee flexion (120 degrees and over), assessing muscle strength, and adverse effects including postoperative nausea and vomiting, postoperative falling, and pruritus.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 04 | Day |
Last modified on
| 2023 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045668
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/12/14 | Protocol_231212.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/06/16 | Research Case Data Specifications.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/06/16 | RawData_230616_Public.csv |
