UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052893 |
|---|---|
| Receipt number | R000058825 |
| Scientific Title | Comparison of postoperative analgesia between femoral nerve block with local infiltration anesthesia and suprainguinal fascia iliaca compartment block with local infiltration anesthesia in the posterior approach to total hip arthroplasty |
| Date of disclosure of the study information | 2023/11/24 |
| Last modified on | 2024/05/24 15:22:47 |
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Basic information
Public title
Comparison of postoperative analgesia between femoral nerve block with local infiltration anesthesia and suprainguinal fascia iliaca compartment block with local infiltration anesthesia in the posterior approach to total hip arthroplasty
Acronym
Comparison of postoperative analgesia between femoral nerve block with local infiltration anesthesia and suprainguinal fascia iliaca compartment block with local infiltration anesthesia in the posterior approach to total hip arthroplasty
Scientific Title
Comparison of postoperative analgesia between femoral nerve block with local infiltration anesthesia and suprainguinal fascia iliaca compartment block with local infiltration anesthesia in the posterior approach to total hip arthroplasty
Scientific Title:Acronym
Comparison of postoperative analgesia between femoral nerve block with local infiltration anesthesia and suprainguinal fascia iliaca compartment block with local infiltration anesthesia in the posterior approach to total hip arthroplasty
Region
| Japan |
Condition
Condition
hip osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the effectiveness of femoral nerve block with local infiltration analgesia and suprainguinal fascia iliaca compartment block with local infiltration analgesia for analgesia after total hip arthroplasty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Numerical Rating Scale (NRS) immediately after surgery (0 hour), 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours
Key secondary outcomes
Nausea and vomiting at 24 hours postoperatively and frequency of rescue analgesia at 12 and 24 hours
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
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
Femoral nerve block combined with local infiltration anesthesia or suprainguinal fascia iliaca compartment block combined with local infiltration anesthesia in patients undergoing total hip arthroplasty
Interventions/Control_2
Evaluate the degree of pain immediately after surgery, 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours after surgery.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing total hip arthroplasty who weigh 50-80 kg and ASA-PS 1-2.
Key exclusion criteria
Patients with hepatic or renal dysfunction, allergies to the subject drug, coagulopathy or systemic anticoagulation, or failure to consent to the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | URABE |
| Middle name | |
| Last name | SHIGEHIKO |
Organization
Nagasaki Rosai Hospital
Division name
Anesthesiology
Zip code
857-0134
Address
2-12-5 Setogoe, Sasebo, Nagasaki
TEL
0956492191
shigehikourabe@yahoo.co.jp
Public contact
Name of contact person
| 1st name | URABE |
| Middle name | |
| Last name | SHIGEHIKO |
Organization
Nagasaki Rosai Hospital
Division name
Anesthesiology
Zip code
857-0134
Address
2-12-5 Setogoe, Sasebo, Nagasaki
TEL
09068953862
Homepage URL
shigehikourabe@yahoo.co.jp
Sponsor or person
Institute
Nagasaki Rosai Hospital
Institute
Department
Personal name
URABE SHIGEHIKO
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
Nagasaki Rosai Hospital
Address
2-12-5 Setogoe, Sasebo, Nagasaki
Tel
0956492191
shigehikourabe@yahoo.co.jp
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
長崎労災病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 24 | 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
50
Results
Twenty-five patients in the FB group (femoral nerve block + local infiltration anaesthesia) and 25 patients in the SFICB group (suprainguinal ligament suprailiac fascial block + local infiltration anaesthesia) (50 patients in total) were enrolled; no difference in NRS at any timing between the two groups was observed, nor in the frequency of rescue analgesia use.
Results date posted
| 2024 | Year | 05 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Consenting patients with ASA 1-2 and weight 50-80 kg for THA surgery.
Participant flow
Preoperative details of research participation were explained and consent obtained.
Adverse events
No adverse events
Outcome measures
The primary endpoint was the numerical rating scale (NRS) immediately after surgery, at 1, 3, 6, 12 and 24 hours, and the secondary endpoints were postoperative nausea and vomiting and the frequency of rescue analgesia.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 24 | Day |
Last modified on
| 2024 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058825
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/05/24 | 股関節全置換術における大腿神経ブロックと鼠径靭帯上ブロックの術後鎮痛効果に関する比較研究 研究計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/05/24 | 長崎労災病院倫理委員会申請書 令和5年.doc |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/05/24 | 大腿神経、腸骨筋膜下前向き研究50.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/58825
