Single Shot Intrathecal Analgesia in Vaginal Delivery

NCT05998551 | Unknown

• 1 other identifier: intra-thecal analgesia
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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

  Up to 6 hours after intrathecal injection

• analgesic onset time

  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

  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

  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

  S1 regression time will be defined as the time from intrathecal injection to sensory regression to S1 dermatome

  6 hours after intrathecal injection

Secondary Outcomes (6)

• Maternal blood pressure

  6 hours post operative

• Maternal heart rate

  6 hours post operative

• Post operative nausea and vomiting

  6 hours post operative

• Post operative urinary retention

  6 hours post operative

• Fetal heart sounds

  from intrathecal injection till delivery

Study Arms (3)

Dexmedetomidine Group

ACTIVE COMPARATOR

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

Fentanyl group

ACTIVE COMPARATOR

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

Control group

ACTIVE COMPARATOR

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

Drug: Bupivacaine Hcl 0.5% Inj

Interventions

Dexmedetomidine DRUG

intrathecal injection of dexmedetomidine added to hyperbaric bupivacaine

Dexmedetomidine Group

Fentanyl DRUG

intrathecal injection of fentanyl added to hyperbaric bupivacaine

Fentanyl group

Bupivacaine Hcl 0.5% Inj DRUG

intrathecal injection of hyperbaric bupivacaine only

Control group

Eligibility Criteria

• Age: 22 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ainshams University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine; Fentanyl; Bupivacaine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Mohamed Nagdy Rashad

CONTACT

01095825826; mohamed.nagdy@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Computer generated number lists and use of sealed opaque envelopes , double blinded trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: August 21, 2023
• Study Start: January 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: October 1, 2023
• Last Updated: August 21, 2023

Record last verified: 2023-05

Locations

EG (1)