Single Shot Intrathecal Analgesia in Vaginal Delivery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-10-01

Brief Summary

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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Computer generated number lists and use of sealed opaque envelopes , double blinded trial

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

intrathecal injection of dexmedetomidine added to hyperbaric bupivacaine

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).

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

intrathecal injection of fentanyl added to hyperbaric bupivacaine

Control group

participants will receive intrathecal injection of 5mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml normal saline

Group Type ACTIVE_COMPARATOR

Bupivacaine Hcl 0.5% Inj

Intervention Type DRUG

intrathecal injection of hyperbaric bupivacaine only

Interventions

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Dexmedetomidine

intrathecal injection of dexmedetomidine added to hyperbaric bupivacaine

Intervention Type DRUG

Fentanyl

intrathecal injection of fentanyl added to hyperbaric bupivacaine

Intervention Type DRUG

Bupivacaine Hcl 0.5% Inj

intrathecal injection of hyperbaric bupivacaine only

Intervention Type DRUG

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.

Minimum Eligible Age

22 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No