This is a clinical trial to study and compare two drugs, chloroprocaine and bupivacaine for the benefits of patients undergoing short period of surgeries or day procedures who can be discharged early.
- Conditions
- Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical,
- Registration Number
- CTRI/2018/05/013574
- Lead Sponsor
- Gayatri Vidya parishad institute of health care and medical technology
- Brief Summary
This is a prospective randomized double blind study, to compare the efficacy and duration of blockade of two local anaesthetics, 1% isobaric 2-chloroprocaine and 0.5% hyperbaric bupivacaine for spinal anaesthesia in day care surgeries and short duration procedures lasting 60 minutes, compared in 60 patients over 6 months duration in below umbilicus elective surgeries of ASA grade I-III of ages 18 to 70. The secondary outcomes include peak level of blockade, time until ambulation and time to reach eligibility to discharge. It is to compare and provide a suitable alternative to low dose long acting local anaesthetics in spinal anaesthesia for ambulatory surgeries.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
ASA I-III, Surgical procedures less than 60minutes ( 1 hour) , elective surgeries, below umbilicus procedures (lower limb, ano-rectal, urological, gynecological surgeries).
patients with contraindications to spinal anaesthesia ( Platelet count < 75,000 , INR >1.5 , use of anti-coagulants, Spinal deformities,, sevre cardiac lesions) , age < 18years > 70years, surgeries lasting more than 60minutes,n patients under ASA IV, V, E, patients allergic or intolerant to local anaesthetic agent, patients who are not willing to be included in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The duration of sensory and motor blockade. 5 minutes to 4 hours
- Secondary Outcome Measures
Name Time Method peak level of blockade, time until ambulation, time to reach eligibility criteria for discharge, complications like transient neurological symptoms (TNS) 5minutes to 12 hours
Trial Locations
- Locations (1)
Gayatri Vidya parishad institute of health care and medical technology
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
Gayatri Vidya parishad institute of health care and medical technology🇮🇳Visakhapatnam, ANDHRA PRADESH, IndiaDr Valluri TejasreePrincipal investigator9949034599drvalluritejasree@gmail.com