]>
IRCT20221109056455N1 IRCT 2023-07-25 Tata Main Hospital, Jamshedpur Effect of hyperbaric Ropivacine in comparison to Bupivacaine for spinal anaesthesia A prospective randomized controlled study comparing 0.75% hyperbaric ropivacaine with 0.5% hyperbaric bupivacaine in spinal anesthesia for elective caesarean delivery 2023-08-01 anticipated 98 Complete https://irct.ir/trial/67189 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study will employ simple randomization using the sealed envelope method. Randomly generated treatment allocations will be given to participating clinicians in sealed, opaque envelopes. A patient is administered the assigned treatment regimen after their consent to participate in the trial has been obtained, Blinding description: The trial will employ the sealed envelope technique. The anesthesiologist who will be providing care will open the randomly selected sealed envelope, give the patient the appropriate medication, and record it in a document next to the patient's recruitment number. The name of the drug will not be disclosed to the investigator until the study is over. The medication will be given to the patient without her knowledge of the drug's name. An observer who is blind to the drugs given will monitor the patient both during surgery and in the recovery room. The research investigator will receive a document with the name of the drug that was administered against the participant recruitment number at the time of data analysis. 3 Delivery by elective Caesarian section. Intervention 1: Group B. 2.6 ml of Bupivacaine 0.5 % heavy intrathecal. Intervention 2: Group R : 2.6 ml of Ropivacaine 0.75 % heavy intrathecal. Yes - There is a plan to make this available What will be shared: IPD data about all observations ( primary and secondary outcomes, demographics) When: 10 years after completion of study To whom: people working in academics Conditions: for meta analysis and review of literature. Where to obtain: Through request to the principal investigator or corresponding author after publication How to obtain: emailed request letter citing purpose and credentials of applicant Comments:
public Dr Gunjan Wadhwa
road C , Northern town, Bistupur,
Jamshedpur India 831001 009198368618827 wadhwagunjan7@gmail.com Tata Main Hospital scientific Dr Gunjan Wadhwa
road C , Northern town, Bistupur,
Jamshedpur India 831001 009198368618827 wadhwagunjan7@gmail.com Tata Main Hospital India ASA physical status 1 and 2 Pregnant adults for elective caesarean section 18 years no limit Female Allergy to Ropivacaine or Bupivacaine Infection at the site for spinal anaesthesia Patient with evidence of foetal distress Short stature (150 cm) Tall stature (>180 cm) Obesity(BMI>30) Patient with an obstetrical complication (multiple gestations, bleeding, gestational hypertensive diseases) Psychiatric or seizure disorder Bleeding disorder Cardiac disease O82.0 Single delivery by elective caesarean section Treatment - Drugs Treatment - Drugs Group B. 2.6 ml of Bupivacaine 0.5 % heavy intrathecal Group R : 2.6 ml of Ropivacaine 0.75 % heavy intrathecal Duration of motor blockade monitored by Bromage scale. Timepoint: 30 min. Method of measurement: Bromage score. Onset of sensory blockade. Timepoint: every 2 minutes after spinal block. Method of measurement: pin prick method. Onset of motor blockade. Timepoint: every 2 minutes after spinal block. Method of measurement: Modified Bromage score. Tata Main Hospital, Jamshedpur Approved 2022-06-06 Institutional Ethics Committee Tata Main Hospital, Jamshedpur Road C, Northern town, Bistupur, Jamshedpur Jamshedpur Jharkhand India