Single Shot Intrathecal Analgesia in Vaginal Delivery

Ain Shams University

Status: Enrolling

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

Treatments: Drug: Fentanyl; Drug: Bupivacaine Hcl 0.5% Inj; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05998551

intra-thecal analgesia

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 estimated patients

Sex: Female

Ages: 22 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 3 patient groups

Dexmedetomidine Group

Active Comparator group

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).

Treatment:

Drug: Dexmedetomidine

Fentanyl group

Active Comparator group

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).

Treatment:

Drug: Fentanyl

Control group

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine Hcl 0.5% Inj