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IRCT20190719044276N2 IRCT 2025-08-07 Iran University of Medical Sciences Effect of Dexamethasone in the labor analgesia The investigation of the intravenous dexamethasone’s effect on the duration of analgesia in pregnant patients undergoing spinal analgesia with opioid (Sufentanil) for Normal Vaginal Delivery (NVD) 2025-07-23 anticipated 120 Complete https://irct.ir/trial/83581 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a simple random sampling method is used to allocate patients to two groups: intervention (receiving dexamethasone) and control (not receiving dexamethasone). First, a list of eligible patients who meet the study inclusion criteria is prepared. Each patient is assigned an identification number (from 1 to 120). Then, using the =RAND() function in Excel software, a random number between zero and one is generated for each number. Patients are sorted in ascending order based on this random number. Next, the first 60 patients are assigned to group A (control), and the second 60 patients are assigned to group B (intervention), Blinding description: In this study, only the person performing the procedure (the relevant physician) is aware of the patient grouping for the procedures, and the person who evaluates the patients and records the checklist information, such as the onset of analgesia and its duration (the relevant nurse), is unaware of the patient grouping. The design analyst (principal investigator) is also unaware of the patient grouping (which groups are Group A and which groups are Group B). Patients (participants in the trial) will be informed of the design grouping method and its practical objectives before starting the necessary procedures. 3 Labor analgesia. Intervention 1: Control group: In this group, patients undergo a single spinal anesthesia with an intrathecal injection of 10 micrograms of the opioid sufentanil from Abu Raihan Company. The needle used in this intervention is a Quincke model and a 26 gauge needle from Dr. G. Company. Intervention 2: Intervention group: In this group, patients undergo spinal anesthesia once with an intrathecal injection of 10 micrograms of the narcotic sufentanil from Abu Raihan Company. The needle used in this intervention is a Quincke model and 26 gauge from Dr. G. Company. Also, at the same time as spinal anesthesia, 8 mg of dexamethasone from Abu Raihan Company is injected intravenously into the patient. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information related to the main outcome or the like, can be shared. When: The access period starts 6 months after results are published. To whom: The data from this project will be accessible to researchers working in academic and scientific institutions. Conditions: Requirements for submitting an application: 1. University professors or students who are conducting research in a field related to the subject of the project. 2. They must commit to mentioning the name of the relevant educational and medical center when using the data. 3. The data must be used to familiarize themselves with the research method, and if it can be used in statistical calculations of the project (for example, statistical comparison of several centers), it must be done with the consent of all authors of the project. Where to obtain: Akbarabadi Medical Training Center Address: Tehran, Molavi St. - Bagh Ferdows Station. Phone: 55606034 Responsible person: Dr. Niloofar Khosravi, Assistant Professor of Anesthesia, Akbarabadi Center How to obtain: Submit a valid letter from the educational and scientific center requesting access to the documents (including the name of the person responsible and his/her scientific and executive position, as well as the director of the relevant center). An explanation of the reasons for requesting access to the said documents and a commitment that the documents will not be made available to unrelated persons. Comments:
public Niloofar Khosravi
Akbarabadi hospital, Molavi street
Tehran Iran (Islamic Republic of) 1168743514 +98 21 5560 6033 n.khosravi991@gmail.com Iran University of Medical Sciences scientific Niloofar Khosravi
Akbarabadi hospital, Molavi street
Tehran Iran (Islamic Republic of) 1168743514 +98 21 5560 6033 n.khosravi991@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Maternal request for labor analgesia Being multiparous (second to fifth labor) Being Term Cervical dilation is equal to 4 cm Normal coagulation state Physical status classification 1 & 2 Availability of normal Non- Stress Test (NST) of fetus 18 years 40 years Female Allergy to dexamethasone Allergy to opioids Pregnant women who are addicted to opioids or illegal drugs Pregnant women with psychiatric diseases Pregnancy with history of diabetes or/and hypertension diseases Pregnant women who are contraindicated for spinal techniques due to Multiple Sclerosis (MS) or other neurological diseases Refuse of pregnant women for doing spinal technique P04.0 Newborn (suspected to be) affected by maternal anesthesia and analgesia in pregnancy, labor and delivery Treatment - Drugs Treatment - Drugs Control group: In this group, patients undergo a single spinal anesthesia with an intrathecal injection of 10 micrograms of the opioid sufentanil from Abu Raihan Company. The needle used in this intervention is a Quincke model and a 26 gauge needle from Dr. G. Company. Intervention group: In this group, patients undergo spinal anesthesia once with an intrathecal injection of 10 micrograms of the narcotic sufentanil from Abu Raihan Company. The needle used in this intervention is a Quincke model and 26 gauge from Dr. G. Company. Also, at the same time as spinal anesthesia, 8 mg of dexamethasone from Abu Raihan Company is injected intravenously into the patient. Duration of analgesia. Timepoint: Determining the patient's pain score using a visual analog scale (VAS) before the start of the intervention, at 1 and 5 minutes after the intervention, and at 2, 3, and 4 hours after the intervention. Method of measurement: Visual Analogue Scale. Iran University of Medical Sciences Approved 2025-05-17 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)