UMIN-CTR Clinical Trial

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
Email	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
Email	t_horiuchi@seichokai.or.jp

Sponsor
Institute	Department of Anesthesia, Bell Land General Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043182