Single Shot Intrathecal Analgesia in Vaginal Delivery

August 11, 2023 updated by: Ain Shams University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • AinShams university
        • Contact:
          • ainshams university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of pain relief
Time Frame: 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
Up to 6 hours after intrathecal injection
analgesic onset time
Time Frame: 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
within 15 minutes after intrathecal injection
maximum level of sensory block
Time Frame: 15 min after the intrathecal injection
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
Time Frame: 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
6 hours after intrathecal injection
S1 regression time
Time Frame: 6 hours after intrathecal injection
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
Time Frame: 6 hours post operative
any change more than 20% of baseline mean arterial pressure
6 hours post operative
Maternal heart rate
Time Frame: 6 hours post operative
any change more than 20% of baseline heart rate
6 hours post operative
Post operative nausea and vomiting
Time Frame: 6 hours post operative
Number of participants having post operative nausea and vomiting
6 hours post operative
Post operative urinary retention
Time Frame: 6 hours post operative
Number of participants having post operative urinary retention
6 hours post operative
Fetal heart sounds
Time Frame: from intrathecal injection till delivery
Change more than 20% of fetal heart sounds before delivery
from intrathecal injection till delivery
Fetal APGAR score
Time Frame: 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
till 5 minutes after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

October 1, 2023

Study Registration Dates

First Submitted

June 16, 2023

First Submitted That Met QC Criteria

August 11, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • intra-thecal analgesia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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