Single-Shot Intrathecal Bupivacaine With Fentanyl vs. Dexmedetomidine for Labor Analgesia: A Randomized Controlled Trial.
Ayman Mohamady Eldemrdash, Taha Tairy Dardeer Elsawy, Zaher Zaki Zaher...
https://pubmed.ncbi.nlm.nih.gov/42063584/Actively Recruiting
Led by Jehan George Sadek · Updated on 2025-07-31
90
Participants Needed
1
Research Sites
4 weeks
Total Duration
Researchers are evaluating the effects of adding either fentanyl or dexmedetomidine to bupivacaine in single shot spinal analgesia during normal labor. This randomized controlled trial aims to compare how these combinations influence pain relief, specifically by measuring the visual analogue scale VAS for pain, the onset, and the duration of analgesia. The study is phase 4 and focuses on improving pain management for women in normal labor. The study involves three groups one receiving 2.5 mg bupivacaine with 25 micrograms fentanyl, another receiving 2.5 mg bupivacaine with 5 micrograms dexmedetomidine, and a control group receiving 2.5 mg bupivacaine with saline. The drugs are administered intrathecally as a single shot at the L3-L4 spinal level. After administration, participants are positioned to prevent aortocaval compression, and pain levels are monitored frequently over about 6 hours. Additional medications like pethidine may be given if pain remains high. Maternal vital signs and side effects are continuously observed and managed. Participants will undergo baseline assessments including demographic data, pain scores, and vital signs before intervention. Pain is assessed regularly using the VAS scale, and maternal blood pressure, heart rate, respiratory rate, and oxygen saturation are monitored closely. Side effects such as nausea, vomiting, and shivering are recorded, along with newborn Apgar scores at 1 and 5 minutes. The study measures the onset and duration of analgesia, changes in pain levels, maternal satisfaction, and obstetric and neonatal outcomes. The total observation period for measurements is approximately 6 hours after the spinal analgesia.
CONDITIONS
Comparative Analysis of Analgesic Efficacy: by Single Shot Intrathecal Analgesia (SSSA) in Normal Labor
J
Jehan G Younan, resident doctor.
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Jehan George Sadek
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - Approximately 6 hours
Participants receive a single shot intrathecal analgesia during labor, and vital signs along with pain scores are monitored closely.
Continuous monitoring with pain scores evaluated every 5 minutes for 30 minutes, then every 20 minutes for 3 hours, followed by every 30 minutes for 3 hours
Duration - Until delivery and immediate post-delivery assessments
Maternal satisfaction and neonatal Apgar scores are assessed around delivery, and any side effects or outcomes are recorded.
1 visit at delivery for satisfaction questionnaire and Apgar scoring
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Ayman Mohamady Eldemrdash, Taha Tairy Dardeer Elsawy, Zaher Zaki Zaher...
https://pubmed.ncbi.nlm.nih.gov/42063584/Jehan George Sadek
Lead Sponsor