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IRCT20191007045023N2 IRCT 2025-06-29 Iran University of Medical Sciences Comparison of Epidural Analgesia and Dural Puncture Analgesia (Spinal/CSE) in Painless Natural Childbirth for Hospitalized Pregnant Women Comparison of Epidural Analgesia and Dural Puncture Analgesia (Spinal/CSE) in Painless Natural Childbirth for Hospitalized Pregnant Women 2025-07-06 anticipated 126 Complete https://irct.ir/trial/82384 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: A table of random numbers will be used to randomize the study participants. To achieve this, the researcher will first determine the direction of movement in the table of random numbers and then place their finger on one of the cells. They will then proceed to move in the predetermined direction. The even numbers identified will be assigned to the conventional epidural group, and the odd numbers will be assigned to the DPE (dural puncture epidural) group. This process will continue until the required sample size is completed, Blinding description: The present study will be conducted as a double-blind trial. To maintain blinding, outcome assessors will remain unaware of the intervention type through the use of randomized codes (e.g., A and B), generated by an independent system and kept confidential until the final analysis. Any identifiers linked to group assignments will be omitted during data collection. Furthermore, by ensuring identical interventions in both groups (in terms of appearance, administration method, and duration) and prohibiting information disclosure by the research team, patients will also remain blinded to their group allocation.". 3 Analgesia. Intervention 1: Intervention group: After identifying the epidural space in the DPE group, a 27-gauge Whitacre pencil-point needle will be inserted using the needle-through-needle technique, perforating the meninges. The needle stylet is then removed to observe the free flow of cerebrospinal fluid (CSF). Once confirmed, the spinal needle is withdrawn, and after injecting 3 mL of normal saline, the epidural catheter will be inserted. The catheter will be fixed in place similarly to the other group. If the aspiration test for blood or CSF is positive, the catheter will be reinserted, and the patient will be excluded from the study. After confirming negative aspiration, a loading dose of 5 micrograms of sufentanil and 10 mL of 0.1% ropivacaine will be administered slowly over 5 minutes with repeated aspirations. An infusion of 10 mL per hour of 0.1% ropivacaine with sufentanil (0.1 micrograms per mL) will then be initiated. In cases where the patient's VAS pain score exceeds 5, 5 mL of 0.1% ropivacaine with 5 micrograms of sufentanil will be administered as emergency analgesia 30 minutes after the initial bolus dose. The time of epidural initiation will be recorded, along with the time required to achieve a VAS score half of the baseline, the VAS score after ten minutes, and the time taken for the VAS score to drop below 3. Intervention 2: Control group: In the group receiving conventional epidural anesthesia, 3 mL of normal saline is injected through the epidural needle, and an 18-gauge epidural catheter is placed into the epidural space, directed cephalad. After this step, the epidural needle is removed, and the epidural catheter is secured so that 3 centimeters remain within the epidural space. No - There is not a plan to make this available Justification or reason for not sharing IPD is Patient data is collected for research purposes only and cannot be published.
public Amineh Shafei nia
Molavi street, Molavi intersection, Ferdowsi garden station
Tehran Iran (Islamic Republic of) 116874351411 +98 21 5560 6034 shafeinia.a@iums.ac.ir Iran University of Medical Sciences scientific Amineh Shafei nia
Molavi street, Molavi intersection, Ferdowsi garden station
Tehran Iran (Islamic Republic of) 116874351411 +98 21 5560 6034 shafeinia.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Age over 18 and under 40 years Full-term pregnancy (gestational age between 37-42 weeks) American Society of Anesthesiologists (ASA) class I and II Body mass index between 20 and 25 kg/m² ervical dilation between 2 and 5 centimeters 18 years 40 years Female Unwillingness to participate in the study Cases complicated by brain or cardiovascular dysfunction Patients who received opioid injections prior to the induction of anesthesia; Patients with spinal column disorders; Preterm delivery Patients with adverse pregnancy outcomes Contraindications for epidural block Patients who deliver within less than one hour from the placement of the epidural catheter P04.0 Newborn (suspected to be) affected by maternal anesthesia and analgesia in pregnancy, labor and delivery Other Other Intervention group: After identifying the epidural space in the DPE group, a 27-gauge Whitacre pencil-point needle will be inserted using the needle-through-needle technique, perforating the meninges. The needle stylet is then removed to observe the free flow of cerebrospinal fluid (CSF). Once confirmed, the spinal needle is withdrawn, and after injecting 3 mL of normal saline, the epidural catheter will be inserted. The catheter will be fixed in place similarly to the other group. If the aspiration test for blood or CSF is positive, the catheter will be reinserted, and the patient will be excluded from the study. After confirming negative aspiration, a loading dose of 5 micrograms of sufentanil and 10 mL of 0.1% ropivacaine will be administered slowly over 5 minutes with repeated aspirations. An infusion of 10 mL per hour of 0.1% ropivacaine with sufentanil (0.1 micrograms per mL) will then be initiated. In cases where the patient's VAS pain score exceeds 5, 5 mL of 0.1% ropivacaine with 5 micrograms of sufentanil will be administered as emergency analgesia 30 minutes after the initial bolus dose. The time of epidural initiation will be recorded, along with the time required to achieve a VAS score half of the baseline, the VAS score after ten minutes, and the time taken for the VAS score to drop below 3. Control group: In the group receiving conventional epidural anesthesia, 3 mL of normal saline is injected through the epidural needle, and an 18-gauge epidural catheter is placed into the epidural space, directed cephalad. After this step, the epidural needle is removed, and the epidural catheter is secured so that 3 centimeters remain within the epidural space. Achieving the desired anesthesia. Timepoint: 10 minutes after the interventions. Method of measurement: Visual Analogue Scale. Maternal satisfaction with analgesia. Timepoint: after intervention. Method of measurement: Checklist. Newborn Apgar score. Timepoint: 1 and 5 minutes after birth. Method of measurement: Checklist. Iran University of Medical Sciences Approved 2024-07-21 Iran university of medical sciences Next to Milad Tower, Hemat Highway ,Tehran Tehran Tehran Iran (Islamic Republic of)