Single Shot Intrathecal Analgesia in Vaginal Delivery

Study Overview
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Brief Summary
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Effectiveness of single shot intra-thecal analgesia in multiparous women scheduled for normal vaginal delivery

Detailed Description
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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.

Official Title
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Effectiveness of Single Shot Intra-thecal Analgesia in Multiparous Women Scheduled for Normal Vaginal Delivery.

Conditions
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Effectiveness of Single Shot Intra-thecal Analgesia in Multiparous Women Scheduled for Normal Vaginal Delivery

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Fentanyl
* Drug: Bupivacaine Hcl 0.5% Inj


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine Group<br>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<br>* intrathecal injection of dexmedetomidine added to hyperbaric bupivacaine<br>|
| Active Comparator: Fentanyl group<br>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<br>* intrathecal injection of fentanyl added to hyperbaric bupivacaine<br>|
| Active Comparator: Control group<br>participants will receive intrathecal injection of 5mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml normal saline | Drug: Bupivacaine Hcl 0.5% Inj<br>* intrathecal injection of hyperbaric bupivacaine only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 6 hours after intrathecal injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal blood pressure | any change more than 20% of baseline mean arterial pressure | 6 hours post operative | 
| Maternal heart rate | any change more than 20% of baseline heart rate | 6 hours post operative | 
| Post operative nausea and vomiting | Number of participants having post operative nausea and vomiting | 6 hours post operative | 
| Post operative urinary retention | Number of participants having post operative urinary retention | 6 hours post operative | 
| Fetal heart sounds | Change more than 20% of fetal heart sounds before delivery | 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 | till 5 minutes after delivery |