An interventional study of Dexmedetomidine and Fentanyl in Effectiveness of Single Shot Intra-thecal Analgesia in Multiparous Women Scheduled for Normal Vaginal Delivery, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to female participants aged 22 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-08-21.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
Effectiveness of single shot intra-thecal analgesia in multiparous women scheduled for normal vaginal delivery
Labor is a physiological and natural process, as well as a complicated and subjective experience.Except for a few women, childbirth is unquestionably a painful experience. Women's understanding of delivery's pain is influenced by various factors, making each experience special. As opposed to other painful life events, labor pain consistently ranks high on the pain rating scale.
In this study ,the investigators are going to investigate the effectiveness and safety of intrathecal analgesia for labour using bupivacaine with fentanyl or dexmedetomidine.
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Multiparous women who received antenatal care, presented for vaginal delivery of uncomplicated term pregnancy of singleton fetus with engaged fetal head and cervical dilatation of at least 5 cm requiring oxytocin augmentation, and requested analgesia.
Refusal of procedure or participation in the study.
participants will receive intrathecal injection of 5mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml contain 5μg dexmedetomidine(0.05ml dexmedetomidine in insulin syringe+ 0.95ml normal saline).
Drug: Dexmedetomidine
participants will receive intrathecal injection of 5 mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml contain 12.5μg fentanyl(0.25ml fentanyl in insulin syringe+ 0.75ml normal saline).
Drug: Fentanyl
participants will receive intrathecal injection of 5mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml normal saline
Drug: Bupivacaine Hcl 0.5% Inj
intrathecal injection of dexmedetomidine added to hyperbaric bupivacaine
intrathecal injection of fentanyl added to hyperbaric bupivacaine
intrathecal injection of hyperbaric bupivacaine only
Duration of pain relief
The duration of pain relief will be defined as the duration from intrathecal injection till the VAS became more than 4
Time frame: Up to 6 hours after intrathecal injection
analgesic onset time
The analgesia onset time will be defined as the time from intrathecal injection until the VAS became less than 4
Time frame: within 15 minutes after intrathecal injection
maximum level of sensory block
Temperature will be assessed using methylated soaked swabs on both sides of the body
Time frame: 15 min after the intrathecal injection
visual analogue scale (VAS) of the labour pain
The VAS (ranging from 0 = pain-free up to 10 = worst imaginable pain) of the labour pain will be recorded before the intrathecal injection, every 5 min for the first 20 min, then every 30 min for 6 hours
Time frame: 6 hours after intrathecal injection
S1 regression time
S1 regression time will be defined as the time from intrathecal injection to sensory regression to S1 dermatome
Time frame: 6 hours after intrathecal injection
Maternal blood pressure
any change more than 20% of baseline mean arterial pressure
Time frame: 6 hours post operative
Maternal heart rate
any change more than 20% of baseline heart rate
Time frame: 6 hours post operative
Post operative nausea and vomiting
Number of participants having post operative nausea and vomiting
Time frame: 6 hours post operative
Post operative urinary retention
Number of participants having post operative urinary retention
Time frame: 6 hours post operative
Fetal heart sounds
Change more than 20% of fetal heart sounds before delivery
Time frame: from intrathecal injection till delivery
Fetal APGAR score
APGAR score (1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2 at 1 and 5 minutes after delivery
Time frame: till 5 minutes after delivery
Plan to share: Undecided
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Ain Shams University