Single Shot Intrathecal Analgesia in Vaginal Delivery

Not Applicable

Recruiting

• Conditions: Effectiveness of Single Shot Intra-thecal Analgesia in Multiparous Women Scheduled for Normal Vaginal Delivery
• Interventions: Drug: Bupivacaine Hcl 0.5% Inj; Drug: Dexmedetomidine; Drug: Fentanyl

• Registration Number: NCT05998551
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-05
• Study First Submitted: 2023-06-16
• Study First Submitted QC: 2023-08-11
• Last Update Submitted: 2023-08-11
• Study First Posted: 2023-08-21
• Last Update Posted: 2023-08-21
• Primary Completion: 2023-09-01
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Bupivacaine Hcl 0.5% Inj	participants will receive intrathecal injection of 5mg (1ml) of 0.5% hyperbaric bupivacaine + 1 ml normal saline
Dexmedetomidine Group	Dexmedetomidine	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).
Fentanyl group	Fentanyl	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).

Primary Outcome Measures

Name	Time	Method
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
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
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
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

Secondary Outcome Measures

Name	Time	Method
Maternal heart rate	6 hours post operative	any change more than 20% of baseline heart rate
Maternal blood pressure	6 hours post operative	any change more than 20% of baseline mean arterial pressure
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
Post operative nausea and vomiting	6 hours post operative	Number of participants having post operative nausea and vomiting
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

Trial Locations

Locations (1)

Ainshams University; 🇪🇬 Cairo, Egypt