Effectiveness of Single Shot Intra-thecal Analgesia in Multiparous Women Scheduled for Normal Vaginal Delivery
Conditions
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.
Interventions
DRUGDexmedetomidine
intrathecal injection of dexmedetomidine added to hyperbaric bupivacaine
DRUGFentanyl
intrathecal injection of fentanyl added to hyperbaric bupivacaine
intrathecal injection of hyperbaric bupivacaine only
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Computer generated number lists and use of sealed opaque envelopes , double blinded trial
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
Eligibility
Sex/Gender
FEMALE
Age
22 Years to 45 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of pain relief | Up to 6 hours after intrathecal injection | The duration of pain relief will be defined as the duration from intrathecal injection till the VAS became more than 4 |
| analgesic onset time | within 15 minutes after intrathecal injection | The analgesia onset time will be defined as the time from intrathecal injection until the VAS became less than 4 |
| maximum level of sensory block | 15 min after the intrathecal injection | Temperature will be assessed using methylated soaked swabs on both sides of the body |
| visual analogue scale (VAS) of the labour pain | 6 hours after intrathecal injection | 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 |
| S1 regression time | 6 hours after intrathecal injection | S1 regression time will be defined as the time from intrathecal injection to sensory regression to S1 dermatome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post operative nausea and vomiting | 6 hours post operative | Number of participants having post operative nausea and vomiting |
| Fetal APGAR score | till 5 minutes after delivery | 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 |
| Maternal blood pressure | 6 hours post operative | any change more than 20% of baseline mean arterial pressure |
| Maternal heart rate | 6 hours post operative | any change more than 20% of baseline heart rate |
| Post operative urinary retention | 6 hours post operative | Number of participants having post operative urinary retention |
| Fetal heart sounds | from intrathecal injection till delivery | Change more than 20% of fetal heart sounds before delivery |
Countries
Egypt
Contacts
Primary ContactMohamed Nagdy Rashad
Outcome results
None listed