Clinical trial NCT05998551: Single Shot Intrathecal Analgesia in Vaginal Delivery
Official title: Effectiveness of Single Shot Intra-thecal Analgesia in Multiparous Women Scheduled for Normal Vaginal Delivery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Effectiveness of Single Shot Intra-thecal Analgesia in Multiparous Women Scheduled for Normal Vaginal Delivery
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 75
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The eligible parturients will be randomly allocated into three groups according to the additive added to a fixed dose of local anesthetic (1ml=5mg of 0.5% hyperbaric bupivacaine).Total volume of 2 ml will be given to each patient
Primary purpose: TREATMENT

Brief summary: Effectiveness of single shot intra-thecal analgesia in multiparous women scheduled for normal vaginal delivery

Detailed description: 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.

Eligibility criteria: * Inclusion criteria:

  * 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.
  * Age: patients between 22-45 years old.
* Exclusion criteria:

  * Refusal of procedure or participation in the study.
  * Patients with pre-existing or pregnancy-induced hypertension, abnormal fetal heart rate tracings, obesity, endocrinal diseases and/or diagnosed fetal abnormalities.
  * Contraindication to neuraxial block.
  * Allergy to any of the study drugs.

Primary outcomes:
measure: Duration of pain relief
timeFrame: Up to 6 hours after intrathecal injection
measure: analgesic onset time
timeFrame: within 15 minutes after intrathecal injection
measure: maximum level of sensory block
timeFrame: 15 min after the intrathecal injection
measure: visual analogue scale (VAS) of the labour pain
timeFrame: 6 hours after intrathecal injection
measure: S1 regression time
timeFrame: 6 hours after intrathecal injection
Secondary outcomes:
measure: Maternal blood pressure
timeFrame: 6 hours post operative
measure: Maternal heart rate
timeFrame: 6 hours post operative
measure: Post operative nausea and vomiting
timeFrame: 6 hours post operative
measure: Post operative urinary retention
timeFrame: 6 hours post operative
measure: Fetal heart sounds
timeFrame: from intrathecal injection till delivery
measure: Fetal APGAR score
timeFrame: till 5 minutes after delivery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ainshams University
Study officials:
References: