Single Shot Intrathecal Analgesia in Vaginal Delivery

Ain Shams University75 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

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

Interventions

DexmedetomidineDRUG

intrathecal injection of dexmedetomidine added to hyperbaric bupivacaine

FentanylDRUG

intrathecal injection of fentanyl added to hyperbaric bupivacaine

Bupivacaine Hcl 0.5% InjDRUG

intrathecal injection of hyperbaric bupivacaine only

Eligibility

Sex: FEMALEMin age: 22 YearsMax age: 45 Years

Medical Language ↔ Plain English

* 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.

Locations (1)

Ainshams University

Cairo, Egypt

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Mohamed Nagdy Rashad

CONTACT

01095825826 mohamed.nagdy@med.asu.edu.eg

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.