UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037877 |
|---|---|
| Receipt number | R000043182 |
| Scientific Title | Efficacy of anterior interosseous nerve block as postoperative analgesia for distal radius fractures (a pilot study) |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2019/08/31 22:06:46 |
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Basic information
Public title
Efficacy of anterior interosseous nerve block as postoperative analgesia for distal radius fractures (a pilot study)
Acronym
Efficacy of anterior interosseous nerve block as postoperative analgesia for distal radius fractures (a pilot study)
Scientific Title
Efficacy of anterior interosseous nerve block as postoperative analgesia for distal radius fractures (a pilot study)
Scientific Title:Acronym
Efficacy of anterior interosseous nerve block as postoperative analgesia for distal radius fractures (a pilot study)
Region
| Japan |
Condition
Condition
Fracture of the distal radius
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Surgery for distal radius fractures (open reduction with palmar locking plate) is often performed with brachial plexus block, but the wound pain may be very strong after the anesthetic effect disappears after surgery. Post-operative pain reduces the satisfaction of patients. Post-operative pain control may be difficult only with non-steroidal anti-inflammatory analgesics and opioids as analgesics, and countermeasures are required. Continuous brachial plexus block is useful for analgesic purposes, but it is a proximal block, which may limit patient activity or cause anxiety due to postoperative paralysis of the upper limbs. It is desirable to perform the minimum necessary blocks.
The wound pain after orthopedic surgery is thought to have mainly originated from the periosteum. In surgery for distal radius fractures, the wound pain of the periosteum (the part to which the locking plate is fixed) on the distal radius side is considered to be the main subject. It is thought that the anterior interosseous nerve, which is a branch of the median nerve, is governed as a sensory nerve at this site, and it has been reported that this nerve block is useful for periosteal pain in wide-awake hand surgery, However, there are no reports using an anterior interosseous nerve block for analgesia after distal radius fracture surgery.
In this study, we evaluate the efficacy of an anterior interosseous nerve block performed at the end of surgery for the time to the first analgesic after surgery as the primary outcome for the distal radius fracture. The improvement of pain score and patient satisfaction is set as secondary outcomes. Since there is no previous study and it is impossible to calculate the sample size, the pilot study will be conducted in 20 cases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Time from brachial plexus block to first analgesic use
Key secondary outcomes
Time from brachial plexus block to first pain
Motor paralysis recovery time
Maximum postoperative pain score (visual analog scale)
Patient age, height, weight, gender
Surgery time
Frequency of postoperative nausea and vomiting
Frequency of postoperative analgesics
Satisfaction with postoperative pain relief
Presence/absence of complications associated with the block (vascular puncture, hematoma, nerve damage, etc.)
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
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
anterior interosseous nerve block at the end of surgery (0.75% ropivacaine 10ml)
Interventions/Control_2
anterior interosseous nerve block at the end of surgery (normal saline 10ml)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing surgery for distal radius fractures under open anesthesia (open reduction with palmar locking plate) with written consent at Bell Land General Hospital
Key exclusion criteria
Patients who have not consented to this clinical study, patients under 18 years of age, patients with hypersensitivity or severe adverse events to ropivacaine, patients who are judged inappropriate for inclusion
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toshinori |
| Middle name | |
| Last name | Horiuchi |
Organization
Bell Land General Hospital
Division name
Department of Anesthesia
Zip code
599-8247
Address
500-3, Higashiyama, Naka-Ku, Sakai, Osaka
TEL
0722342001
t_horiuchi@seichokai.or.jp
Public contact
Name of contact person
| 1st name | Toshinori |
| Middle name | |
| Last name | Horiuchi |
Organization
Bell Land General Hospital
Division name
Department of Anesthesia
Zip code
599-8247
Address
500-3, Higashiyama, Naka-Ku, Sakai, Osaka
TEL
0722342001
Homepage URL
t_horiuchi@seichokai.or.jp
Sponsor or person
Institute
Department of Anesthesia, Bell Land General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bell land General Hospital Institution Review Board
Address
500-3, Higashiyama, Naka-Ku, Sakai, Osaka
Tel
0722342001
irb@seichokai.or.
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
ベルランド総合病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 31 | Day |
Last modified on
| 2019 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043182
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