Comparison of Analgesic Effectiveness and Safety of Vapocoolant Spray and Eutectic Mixture of Local Anaesthetic Cream for Spinal Anaesthesia Injection: Randomized Control Trial

Comparison of Analgesic Effectiveness and Safety of Vapocoolant Spray and Eutectic Mixture of Local Anaesthetic Cream for Spinal Anaesthesia Injection in Tertiary Care Hospital of Uttarakhand: Randomized Control Trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084830

Enrollment

140

Registered

2025-04-15

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: EMLA CREAM: EMLA CREAM- Eutectic Mixture of Local Anaesthetics, which include Lidocaine and Prilocaine Route of administration- Topical Duration- 30 mins before procedure Intervention2

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 18-65 years old. 2. Lower limb surgery under spinal anaesthesia 3. Lower abdominal and perineal surgeries under Spinal anaesthesia. 4. ASA grade 1- 2 5. Both gender

Exclusion criteria

Exclusion criteria: 1. Patient refusal, 2. Emergency procedure 3. Pregnant female 4. ASA 3 and above 5. Allergic to local Anaesthetics 6. Cardiac disease 7. Spinal deformity 8. Neurological and psychiatric disorders.

Design outcomes

Primary

Measure	Time frame
NRS in both groups at different time intervalsTimepoint: baseline, 1 min, 2 min , 3 min , 4min, 5 min	—

Secondary

Measure	Time frame
Incidence of adverse events e.g., skin irritation, allergic reactions, & change in hemodynamics (Mean arterial pressure & Heart Rate). Patient satisfaction outcomes according to the 5-point Likert scale Very satisfied, Satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied. Timepoint: baseline, 1 min, 2 min, 3 min, 4min, 5min	—

Countries

India

Contacts

Public ContactDr Mohit Kumar

Veer Chandra Singh Garhwali Government Medical Sciences and Research Institute

drmohitsaini87@gmail.com9634428683

Outcome results

None listed

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