A prospective randomized controlled study comparing 0.75% hyperbaric ropivacaine with 0.5% hyperbaric bupivacaine in spinal anesthesia for elective caesarean delivery

To compare 0.75% Hyperbaric Ropivacaine with 0.5% Hyperbaric Bupivacaine in Spinal anaesthesia for caesarean delivery in terms of onset and duration of sensory and motor block

1. A prospective, phase 3, single-centre, randomised, controlled, double-blind study involving 49 adult pregnant women in each group who are scheduled to have an elective caesarean delivery, enrolled between August 2023 and April 2024.

The study will be conducted at the obstetric unit of tertiary care facility Tata Main Hospital in Jamshedpur, India's eastern region. The concerned anesthesiologist will administer the spinal block in accordance with group assignment after obtaining informed consent from the participants, who will be randomly assigned to one of the two groups using the sealed envelope simple randomization method. Then principle investigator will observe and collect data.

Inclusion criteria- 1. Adult pregnant women (Age ≥ 18 Years) undergoing elective caesarean delivery under spinal anaesthesia 2. ASA grades I and II Exclusion criteria 1. Pre-term Pregnancy (<37 weeks of Gestational age) 2. Patients having obstetric complications (psychiatric, neurologic, cardiac or hemologic disease, diabetes, multiple gestation, preeclampsia, eclampsia, bleeding, or coagulation disorder) 3. Patients with evidence of foetal compromise 4. Patients with heights of 150 cm or > 180 cm 5. Patients with BMI ≥ 30 6. Patient with history of allergy to Ropivacaine or Bupivacaine

Group B: 2.6 ml of 0.5% heavy Bupivacaine Group R: 2.6 ml of 0.75% heavy Ropivacaine

To determine the duration of motor blockade monitored by the Bromage scale after spinal anaesthesia in adult women undergoing elective caesarean section with 0.75% Hyperbaric Ropivacaine and 0.5% Hyperbaric Bupivacaine.

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.

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.

IPD data about all observations ( primary and secondary outcomes, demographics)

10 years after completion of study

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for meta analysis and review of literature.

Through request to the principal investigator or corresponding author after publication

emailed request letter citing purpose and credentials of applicant