OPTIMIZED METHOD OF UNILATERAL SPINAL ANESTHESIA

OPTIMIZED METHOD OF UNILATERAL SPINAL ANESTHESIA: DOUBLE BLIND, RANDOMISED CLINICAL STUDY - OPTIMUS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000049554

Enrollment

133

Registered

2022-11-18

Start date

2018-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 t

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
Satisfaction and adherence of patients and anesthesiologists to unilateral spinal anesthesia technique.	—

Countries

Asia(except Japan)

Contacts

Public ContactYernar Mamyrov

Pavlodar Branch of NCJSC Semey Medical University Department of Emergency Medicine

pavlodar@nao-mus.kz+7(7182)55-28-54

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026