UMIN-CTR Clinical Trial

Basic information
Public title	OPTIMIZED METHOD OF UNILATERAL SPINAL ANESTHESIA
Acronym	OPTIMUS
Scientific Title	OPTIMIZED METHOD OF UNILATERAL SPINAL ANESTHESIA: DOUBLE BLIND, RANDOMISED CLINICAL STUDY
Scientific Title:Acronym	OPTIMUS
Region	Asia(except Japan)

Condition
Condition	Our study, which is a clinically controlled, multicenter, double-blind, equally randomized, parallel-group study, that was conducted in Kazakhstan, was conducted after the approval of the ethics committee (Protocol No. 1, dated 28.09.2018). The study was carried out in two centers, in particular, at the NCJSC SMU University Hospital of NCJSC SMU in Semey, Kazakhstan, which is the regional center of the Abay region with a population of about 650,000 people. The second center for conducting the study was the City Hospital No.1 of Pavlodar, Kazakhstan, which is also a regional center with a population of 750,000 people.
Classification by specialty	Medicine in general Vascular surgery Anesthesiology Intensive care medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1. reduce the rate of complications related to spinal puncture. 2. increase the quality of anesthesia and, respectively, patient satisfaction. 3. simplify USpA and reduce the number of unsuccessful punctures by using electrical nerve stimulation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. UsPA + ENS reduces the incidence of unwanted puncture complications, namely Postdural Punture Headache (PDPH), nausea, vomiting, number of puncture attempts. 2. improves the quality of anesthesia, namely: patient satisfaction according to Visual Analogue Scale (VAS), Lateralisation of anesthesia, Adequacy of anesthesia
Key secondary outcomes	Satisfaction and adherence of patients and anesthesiologists to unilateral spinal anesthesia technique.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	For main group Unilateral Spinal Anesthesia with electrical nerve stimulation were performed (USpA+ENS technique description): 1. I/V Infusion of 8 ml/kg of crystalloids preoperatively. 2. Laying the patient in a lateral decubitus position of the upcoming operation side . 3. Local skin anesthesia 4-5 ml of 0.5% solution of Novocaine solution 4. Puncture of the epidural space with resistance loss test (level L2-L3, L3-L4 Stimuplex 21-22G needle 50 mm long connected to a neurostimulator). 5. Through the needle, the current is supplied with a power of 4 MA, a frequency of 2 Hz, a pulse duration of 0.1 ms, until the Dura is punctured, but not more than 30 seconds. 6. Passing through the needle for neurostimulation, the usual spinal needle size 29G - 90 mm with a Quincke cut to puncture the dura. 7. Immediately after the dura puncture, the current is transmitted along the inner wall of the needle for neurostimulation to the spinal needle and reaches the subarachnoid space. 8. The anesthesiologist observed the action of electric current visually - muscle contractions of the interested or both limbs for 5-10 seconds. 9. The patient felt irritated by the electric current and immediately reported verbally to the anesthesiologist in 5-10 seconds. 10. Checking the free flow of CSF through the spinal needle for 5-10 seconds. Turning the bevel of the needle caudally. 11. Slow, within 100-120 seconds, the introduction of 7.5 mg of LA - Bupivacaine-Spinal. 12. Remove the needle, apply an aseptic dressing, exposure for 15-20 minutes on the lateral decubitus position
Interventions/Control_2	For control group usual Unilateral Spinal Anesthesia were performed (Usual USpA technique description): 1. I/V Infusion of 8 ml/kg of crystalloids preoperatively. 2. Laying the patient in a lateral decubitus position of the upcoming operation side . 3. Local skin anesthesia 4-5 ml of 0.5% solution of Novocaine solution 4. Puncture of the subarachnoid space (level L2-L3, L3-L4 Spinal needle 27G with intoducer is used). 5. Checking the free flow of CSF through the spinal needle for 5-10 seconds. Turning the bevel of the needle caudally. 6. Slow, within 100-120 seconds, the introduction of 7.5 mg of LA - Bupivacaine-Spinal. 7. Remove the needle, apply an aseptic dressing, exposure for 15-20 minutes on the lateral decubitus position
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	25 years-old <
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1. patients with upcoming operations for varicose veins of the lower extremities, mainly saphenectomy and crossectomy with CEAP clinical classes from C2 to C4. 2. age from 25 to 65; 3. anesthetic risk according to ASA-I-IV class; 4. signed informed consent of the patient.
Key exclusion criteria	1. refusal to participate in the study; 2. risk according to ASA V class; 3. coagulopathy of various ethiologies; 4.acute cardiac and / or respiratory failure; 5. hypovolemia; 6. intolerance to local anesthetics; 7. skin and soft tissues infection in the area of the proposed puncture; 8. peripheral neuropathy; 9. cognitive/psychiatric disorders or alcohol/drug dependence causing inability to adhere to the study protocol 10. patient's refusal from regional anesthesia
Target sample size	133

Research contact person
Name of lead principal investigator	1st name Yernar Middle name Dauletovich Last name Mamyrov
Organization	Pavlodar Branch of NCJSC Semey Medical University
Division name	Department of Emergency Medicine
Zip code	140000
Address	Tolstogo str, 19-57, Pavlodar, Pavlodar region, Kazakhstan
TEL	+77077999003
Email	genius.earnico@gmail.com

Public contact
Name of contact person	1st name Yernar Middle name Dauletovich Last name Mamyrov
Organization	Pavlodar Branch of NCJSC Semey Medical University
Division name	Department of Emergency Medicine
Zip code	140002
Address	Toraigyrov str, 72/1, Pavlodar, Pavlodar region, Kazakhstan
TEL	+7(7182)55-28-54
Homepage URL	https://semeymedicaluniversity.kz/en/about-us/structure/branches/pavlodar-branch-of-the-university/
Email	pavlodar@nao-mus.kz

Sponsor
Institute	NCJSC Semey Medical University
Institute
Department

Funding Source
Organization	There is no funding source for this study, the study is carried out in frames of PhD doctoral study program, with the use of materials and conditions of NSJSC SMU and Pavlodar city hospital No.1
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	Pavlodar Branch of NCJSC Semey Medical University, Department of Emergency Medicine
Address	Toraigyrov str, 72/1, Pavlodar, Pavlodar region, Kazakhstan
Tel	+7(7182)55-28-54
Email	genius.earnico@gmail.com

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	1. University hospital of NCJSC SMU (Semey, Kazakhstan). 2. City hospital No.1 (Pavlodar, Kazakhstan)

Other administrative information
Date of disclosure of the study information	2022 Year 11 Month 18 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	134
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Because of late preparation of Original article for publication in Peer viewed journal, as a cause of that in the period from the end of 2019 to the beginning of 2022, our team was involved in the fight against COVID-19 in our country. Most of the staff of Department of Emergency Medicine are the Anesthesiologists and Intensive care physicians. That's why by the order of the local health department, we were directed to treat patients with COVID-19
Date of the first journal publication of results	2023 Year 02 Month 01 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2018 Year 09 Month 28 Day
Date of IRB	2023 Year 02 Month 01 Day
Anticipated trial start date	2018 Year 10 Month 01 Day
Last follow-up date	2019 Year 03 Month 30 Day
Date of closure to data entry	2019 Year 06 Month 30 Day
Date trial data considered complete	2022 Year 10 Month 01 Day
Date analysis concluded	2022 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date	2022 Year 11 Month 18 Day
Last modified on	2022 Year 11 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056422