Back to resultsSingle Shot Intrathecal Analgesia in Vaginal Delivery
Primary Purpose
Effectiveness of Single Shot Intra-thecal Analgesia in Multiparous Women Scheduled for Normal Vaginal Delivery
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
Fentanyl
Bupivacaine Hcl 0.5% Inj
Sponsored by
About this trial
This is an interventional treatment trial for Effectiveness of Single Shot Intra-thecal Analgesia in Multiparous Women Scheduled for Normal Vaginal Delivery
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.
Sites / Locations
- Ainshams UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Dexmedetomidine Group
Fentanyl group
Control group
Arm Description
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).
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).
participants will receive intrathecal injection of 5mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml normal saline
Outcomes
Primary Outcome Measures
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
analgesic onset time
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
Temperature will be assessed using methylated soaked swabs on both sides of the body
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
S1 regression time
S1 regression time will be defined as the time from intrathecal injection to sensory regression to S1 dermatome
Secondary Outcome Measures
Maternal blood pressure
any change more than 20% of baseline mean arterial pressure
Maternal heart rate
any change more than 20% of baseline heart rate
Post operative nausea and vomiting
Number of participants having post operative nausea and vomiting
Post operative urinary retention
Number of participants having post operative urinary retention
Fetal heart sounds
Change more than 20% of fetal heart sounds before 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05998551
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effectiveness of Single Shot Intra-thecal Analgesia in Multiparous Women Scheduled for Normal Vaginal Delivery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Computer generated number lists and use of sealed opaque envelopes , double blinded trial
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexmedetomidine Group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Fentanyl group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
participants will receive intrathecal injection of 5mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml normal saline
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
intrathecal injection of dexmedetomidine added to hyperbaric bupivacaine
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
intrathecal injection of fentanyl added to hyperbaric bupivacaine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hcl 0.5% Inj
Intervention Description
intrathecal injection of hyperbaric bupivacaine only
Primary Outcome Measure Information:
Title
Duration of pain relief
Description
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
Title
analgesic onset time
Description
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
Title
maximum level of sensory block
Description
Temperature will be assessed using methylated soaked swabs on both sides of the body
Time Frame
15 min after the intrathecal injection
Title
visual analogue scale (VAS) of the labour pain
Description
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
Title
S1 regression time
Description
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 Outcome Measure Information:
Title
Maternal blood pressure
Description
any change more than 20% of baseline mean arterial pressure
Time Frame
6 hours post operative
Title
Maternal heart rate
Description
any change more than 20% of baseline heart rate
Time Frame
6 hours post operative
Title
Post operative nausea and vomiting
Description
Number of participants having post operative nausea and vomiting
Time Frame
6 hours post operative
Title
Post operative urinary retention
Description
Number of participants having post operative urinary retention
Time Frame
6 hours post operative
Title
Fetal heart sounds
Description
Change more than 20% of fetal heart sounds before delivery
Time Frame
from intrathecal injection till delivery
Title
Fetal APGAR score
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Nagdy Rashad
Phone
01095825826
Email
mohamed.nagdy@med.asu.edu.eg
Facility Information:
Facility Name
Ainshams University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ainshams university
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Single Shot Intrathecal Analgesia in Vaginal Delivery
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