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Phase 4
FEMALE
Healthy Volunteers
ID06823349

Comparing Pain Relief Using Single Shot Intrathecal Bupivacaine with Fentanyl or Dexmedetomidine During Normal Labor

Led by Jehan George Sadek · Updated on 2025-07-31

90

Participants Needed

1

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

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

Brief Title

Comparative Analysis of Analgesic Efficacy: by Single Shot Intrathecal Analgesia (SSSA) in Normal Labor

Research Team

J

Jehan G Younan, resident doctor.

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