Comparison of two different doses of intrathecal ropivacaine on onset and duration of sensory and motor block in patients undergoing cesarean section with spinal anesthesia

Comparison of two different doses of intrathecal ropivacaine on onset and duration of sensory and motor block in patients undergoing cesarean section with spinal anesthesia

A randomized double-blind clinical trial, with parallel groups, phase 3 on 66 patients. A table of random numbers is used for randomization.

66 patients who are candidates for cesarean section who refer to Shahid Sadoughi Hospital in Yazd are randomly divided into two equal groups: Patients received 20 mg ropivacaine (group 1) and patients received 30 mg ropivacaine (group 2). The syringes were prepared and coded by a collaborator with the same volume equal to 6 cc. Half of the syringes contained 30 mg of 0.5% rupivocaine and the other half contained 20 mg of rupivocaine 0.5% and 2 cc of normal saline. For all patients, hemodynamic variables including systolic, diastolic and mean arterial blood pressure were measured every 3 minutes until birth and then every 5 minutes until the end of surgery. Pin-prick test was used to assess the sensory level and modified Bromage scale was used to assess the motor block.

Inclusion criteria were women aged 18-40 with term pregnancy and ASA (American Society of Anesthesiologists) Class 1 and candidates for non-emergency cesarean section under the spinal anesthesia. Exclusion criteria were: patient dissatisfaction with entering the study, fetal anomalies, and heart, liver, kidney or cerebrovascular diseases, preeclampsia, eclampsia, weighing less than 50 kg or more than 100 kg, sensitivity to any of the drugs used in the study

patients received 20 mg ropivacaine and patients received 30 mg ropivacaine

Faster and longer sensory and motor blocks and higher surgeon satisfaction with higher doses of intrathecal ropivacaine, without any side effects

This clinical trial was designed by simple randomization using a random number table. The project partner placed participants with even random numbers in the intervention group (30 mg rupivacaine) and participants with odd random numbers in the control group (20 mg rupivacaine) in order of entry of participants.

After obtaining informed consent, participants were placed in group 1 or 2 by a project partner using a random number table. The participant and the researcher did not know any of the assignments in the groups. Rupivacaine-containing syringes were prepared and coded by a design partner with an equal volume of 6 cc. Half of the syringes contained 30 mg of 0.5% ropivacaine with a volume of 6 cc and the other half contained 20 mg of 0.5% ropivacaine and 2 cc of normal saline with a volume of 6 cc. During the project, depending on the assignment of the participant to group 1 or 2, the project partner, as the only informed person, delivers the syringe containing rupivacaine (20 or 30 mg) to the researcher for intrathecal injection. Therefore, the specialist physician did not know the concentration of rupivacaine in the syringes and evaluated the patients during the study.

All data are shareable after unidentified individuals

Access period starts 6 months after the publication of the results

Data will be available to researchers working in academic and scientific institutions

Studied data can be used to compare with similar researches

Refer to the e-mail, dr.m.niknafs@gmail .com

After sending the reason for the request for data files and reviewing it, the documents will be sent within two weeks