UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005789 |
|---|---|
| Receipt number | R000006847 |
| Scientific Title | Effects of continuous sciatic nerve block added to continuous femoral nerve block for postoperative analgesia after total knee arthroplasty |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2013/04/08 14:56:49 |
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Basic information
Public title
Effects of continuous sciatic nerve block added to continuous femoral nerve block for postoperative analgesia after total knee arthroplasty
Acronym
Effects of continuous sciatic nerve block added to continuous femoral nerve block for postoperative analgesia after total knee arthroplasty
Scientific Title
Effects of continuous sciatic nerve block added to continuous femoral nerve block for postoperative analgesia after total knee arthroplasty
Scientific Title:Acronym
Effects of continuous sciatic nerve block added to continuous femoral nerve block for postoperative analgesia after total knee arthroplasty
Region
| Japan |
Condition
Condition
Patients undergoing unilateral total knee arthroplasty under general anesthesia
Classification by specialty
| Orthopedics | Anesthesiology | Operative medicine |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the analgesic efficacy of continuous sciatic nerve block compared with single shot sciatic nerve block after total knee arthroplasty. In addition to either continuous or single shot sciatic nerve block, both groups are provided with continuous femoral nerve block and intravenous morphine patient-controlled analgesia system concurrently.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total morphine consumption within 48 hours after surgery
Key secondary outcomes
Visual analogue scale scores, incidence of adverse effects of morphine, the maximum angle of the continuous passive motion of the operated knee on the postoperative day 7 and hospital length of stay
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Femoral and sciatic nerve blocks are performed just before surgery and perineural catheters are inserted for both peripheral nerves. After surgery, continuous sciatic nerve block (5 ml/h of 0.2% ropivacaine) is provided for 48 hours in addition to continuous femoral nerve block and intravenous morphine patient-controlled analgesia system (1 mg morphine every 10 minutes as needed).
Interventions/Control_2
Femoral and sciatic nerve blocks are performed just before surgery and perineural catheters are inserted for both peripheral nerves. After surgery, sham continuous sciatic nerve block (5 ml/h of normal saline) is provided for 48 hours in addition to continuous femoral nerve block and intravenous morphine patient-controlled analgesia system (1 mg morphine every 10 minutes as needed).
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients undergoing unilateral total knee arthroplasty
Key exclusion criteria
ASA physical status above 3
Fixed valgus and flexion deformities
Rivision knee replacement
Impaired cognitive function
Neuromuscular diseases
Vascular diseases on lower extremities
Diabetes mellitus with insulin therapy
Morbid obesity (body mass index > 35)
Impaired renal function (serum creatinine > 1.5)
Contraindication for peripheral nerve blocks (coagulation abnormalities, infection at the puncture site, allegy to local anesthetics)
Gastric ulcer
Allergy to NSAIDs
Pregnancy or breast feeding
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keita Sato |
Organization
Kitano Hospital
Division name
Department of anesthesiology
Zip code
Address
2-4-20, Ogi-machi, Kita-ku, Osaka, Japan
TEL
06-6312-1221
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kitano Hospital
Division name
Department of anesthesiology
Zip code
Address
2-4-20,Ogi-machi, Kita-ku, Osaka, Japan
TEL
Homepage URL
Sponsor or person
Institute
Kitano Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
財団法人田附興風会医学研究所 北野病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 16 | Day |
Last modified on
| 2013 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006847
