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IRCT20230403057808N1 IRCT 2023-04-19 Rasht University of Medical Sciences Intrathecal injection of fentanyl and sufentanil along with bupivacaine in painless labor Comparison of intrathecal injection of fentanyl and sufentanil along with bupivacaine in the onset, duration and quality of painless labor; A randomized double-blind clinical trial 2023-04-21 anticipated 80 Complete https://irct.ir/trial/69384 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible pregnant mothers who have given informed consent to participate in the study will be assigned to one of the two groups of bupivacaine with fentanyl and bupivacaine with sufentanil by an Anesthetist technician who is not involved in the study, with a random sequence in blocks of four created by computer (WinPepi software11.65), with the sequence of randomization blocks in a ratio of 1:1.Allocation concealment will be used for implementing the random sequence of participants in the study. So before assigning the person, the assigned group will not be This will prevent participants and researchers from knowing about the subsequent allocation. In order to maintain the random sequence, the outer surface of the envelopes is numbered in the same order. In order to maintain the random sequence, the outer surface of the envelopes will be numbered in the same order. At the time of registration of eligible patients for the study, one of the envelopes will be opened and the patient will be a candidate for one of the two methods of analgesia, Blinding description: In order to double-blind the study, the anesthesiologist who prepares the study drug also performs the neuraxial block in order to take the necessary actions in case of side effects. Data collection will be done by the anesthesia assistant responsible for the project. In this study, the pregnant mother and the evaluator will be unaware of the type of drug used. 3 Intrathecal injection of fentanyl and sufentanil in combination with bupivacaine in onset, duration and quality of painless labor. Intervention 1: Intervention group1: In sterile conditions, a 25-size needle (B.Brown company)will be entered into the intraspinal space through lumbar vertebrae L3-L4 or L4-L5, and after ensuring the flow of cerebrospinal fluid, the injection will be performed. In the bupivacaine-fentanyl group, 2.5 milligrams of bupivacaine (manufactured by Aspen Company) will be injected with 25 micrograms of fentanyl (manufactured by Darupakhsh Company, Iran). The total volume of the solution is one milliliter. Intervention 2: Intervention group2 : In sterile conditions, a 25-size needle (B.Brown company)will be entered into the intraspinal space through lumbar vertebrae L3-L4 or L4-L5, and after ensuring the flow of cerebrospinal fluid, the injection will be performed. In the bupivacaine-sufentanil group, 2.5 milligrams of bupivacaine (manufactured by Aspen Company) will be injected along with 2.5 micrograms of sufentanil (manufactured by Aburihan Company, Iran). The total volume of the solution is one milliliter. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Not decided yet
public Samaneh Ghazanfar Tehran
Anesthesiology Research Center, Alzahra Hospital, Namjoo Street, Rasht, Iran
Rasht Iran (Islamic Republic of) 4144654839 +98 13 3332 9524 Tehranisamaneh88rasht@gmail.com Rasht University of Medical Sciences scientific Samaneh Ghazanfar Tehran
Anesthesiology Research Center, Alzahra Hospital, Namjoo Street, Rasht, Iran
Rasht Iran (Islamic Republic of) 4144654839 +98 13 3332 9524 Tehranisamaneh88rasht@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Primiparous or multiparous pregnant mothers with term pregnancy Single fetus American Society of Anesthesiologists' (ASA) classification I, II In the advanced stage of labor with cervical dilation at least 5 centimeter in Primiparous and at least 4 centimeter in multiparous mothers Age more than 18 years Tending to have painless labor 18 years no limit Female Refusal to participate in the study by pregnant mothers Obesity Endocrine disease Drug abuse Allergy to study drugs Regional anesthesia contraindications such as coagulopathy, high intracranial pressure and infection of injection site . O75.9 Complication of labor and delivery, unspecified Treatment - Surgery Treatment - Surgery Intervention group1: In sterile conditions, a 25-size needle (B.Brown company)will be entered into the intraspinal space through lumbar vertebrae L3-L4 or L4-L5, and after ensuring the flow of cerebrospinal fluid, the injection will be performed. In the bupivacaine-fentanyl group, 2.5 milligrams of bupivacaine (manufactured by Aspen Company) will be injected with 25 micrograms of fentanyl (manufactured by Darupakhsh Company, Iran). The total volume of the solution is one milliliter. Intervention group2 : In sterile conditions, a 25-size needle (B.Brown company)will be entered into the intraspinal space through lumbar vertebrae L3-L4 or L4-L5, and after ensuring the flow of cerebrospinal fluid, the injection will be performed. In the bupivacaine-sufentanil group, 2.5 milligrams of bupivacaine (manufactured by Aspen Company) will be injected along with 2.5 micrograms of sufentanil (manufactured by Aburihan Company, Iran). The total volume of the solution is one milliliter. Mean time of onset of sensory block. Timepoint: At zero, 5, 10, 15, 30, 45, 60, 90, 120 and 150 minutes after injection. Method of measurement: Pinprick response in both lower limbs. Mean time of duration of sensory block. Timepoint: At zero, 5, 10, 15, 30, 45, 60, 90, 120 and 150 minutes after injection. Method of measurement: Pinprick response in both lower limbs. The state of motor block. Timepoint: At zero, 5, 10, 15, 30, 45, 60, 90, 120 and 150 minutes after injection. Method of measurement: Bromage test: zero (full flexion of knees and ankles), one (ability to move only knees), two (ability to move only legs), and three (inability to move knees and feet). Labor pain score. Timepoint: At zero, 5, 10, 15, 30, 45, 60, 90, 120 and 150 minutes after injection. Method of measurement: Based on visual analog scale as 1-10. Satisfaction status of pregnant mothers with the quality of analgesia. Timepoint: After transferring pregnant mothers to recovery and stabilization of vital signs. Method of measurement: Numerical Rating (NRS) based on percentage. Drug complications: (Blood pressure drop more than 20% of baseline, itching, chills, nausea and vomiting, cases leading to cesarean section). Timepoint: The duration of the procedure. Method of measurement: Observance. Rasht University of Medical Sciences Approved 2023-03-01 Ethics committee of Guilan University of Medical Sciences Vice Chancellor for research, Shahid Siadati Avenue, Namjoo Street,Rasht Rasht Guilan Iran (Islamic Republic of)