A study looking at the effects of low dose local anesthetic solution compared to its standard dose in spinal anesthesia in patients undergoing varicose vein operation in daycare setting.

Effects of hyperbaric Bupivacaine (10mg) Versus low dose diluted hyperbaric Bupivacaine (5mg) on the quality and duration of subarachnoid block in ambulatory EVLA (Endovenous Laser Ablation)-A randomized controlled trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/04/024757

Enrollment

Registered

2020-04-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: I839- Asymptomatic varicose veins of lower extremities Health Condition 2: I839- Asymptomatic varicose veins of lower extremities

Interventions

Intervention1: low dose diluted hyperbaric bupivacaine (5mg): low dose diluted hyperbaric bupivacaine (5mg) in subarachnoid block for endovenous laser ablation surgery for varicose veins. Control Inte

Eligibility

Inclusion criteria

Inclusion criteria: All patients (ASA I, II) coming for treatment of varicose veins with endovenous laser ablation aged between 18- 70 years.

Exclusion criteria

Exclusion criteria: 1. Age > 70 years 2. ASA III and IV 3. BMI > 30 4. Obstructive sleep apnoea 5. Impaired renal function (serum creatinine > 1.4mg/dl) 6. Moderate to severe chronic obstructive lung disease 7. Previous surgical procedures in the lumbosacral region. 8. Pregnant women 9. Patient refusal 10.Allergic to local anaesthetics.

Design outcomes

Primary

Measure	Time frame
To compare the Level of peak sensory block which is assessed at 2 minutes interval from the time of subarachnoid injection to until maximum block is acheived in patients receiving subarachnoid block with local anaesthetic hyperbaric bupivacaine 10 mg or low dose diluted hyperbaric bupivacaine 5mg for endovenous laser ablation surgery for varicose veins.Timepoint: Every 2 minutes from the time of Subarachnoid injection to until maximum level of sensory block is achieved.	—

Measure

Time frame

To compare the Level of peak sensory block which is assessed at 2 minutes interval from the time of subarachnoid injection to until maximum block is acheived in patients receiving subarachnoid block with local anaesthetic hyperbaric bupivacaine 10 mg or low dose diluted hyperbaric bupivacaine 5mg for endovenous laser ablation surgery for varicose veins.Timepoint: Every 2 minutes from the time of Subarachnoid injection to until maximum level of sensory block is achieved.

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Secondary

Measure	Time frame
Any adverse events(Bradycardia,Hypotension,Respiratory distress,Nausea and Vomiting)Timepoint: End of surgery;Time to discahrge-each patientâ??s discharge eligibility using PADS score will be assessed.Timepoint: End of surgery;To compare the Degree of motor blockTimepoint: At the time when maximum level of sensory block is achieved and at the end of surgery.;To compare the duration of sensory and motor block.Timepoint: End of surgery ;To compare the time to readiness for surgery(time to T12 level sensory block)Timepoint: Every 2 minutes from the time of Subarachnoid injection until T12 level sensory block is achieved.	—

Measure

Time frame

Any adverse events(Bradycardia,Hypotension,Respiratory distress,Nausea and Vomiting)Timepoint: End of surgery;Time to discahrge-each patientâ??s discharge eligibility using PADS score will be assessed.Timepoint: End of surgery;To compare the Degree of motor blockTimepoint: At the time when maximum level of sensory block is achieved and at the end of surgery.;To compare the duration of sensory and motor block.Timepoint: End of surgery ;To compare the time to readiness for surgery(time to T12 level sensory block)Timepoint: Every 2 minutes from the time of Subarachnoid injection until T12 level sensory block is achieved.

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Countries

India

Contacts

Public ContactDr Chitra S

Christian Medical College ,Vellore

dranimol001@gmail.com9489594958

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026