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Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor

T

Tanta University

Status and phase

Completed
Phase 4

Conditions

Epidural Analgesia
Levobupivacaine
Fentanyl
Dexmedetomidine
Painless Labor

Treatments

Drug: Dexmedetomidine
Drug: levobupivacaine
Drug: Fentanyl

Study type

Interventional

Funder types

Other

Identifiers

NCT04397406
33447/10/19

Details and patient eligibility

About

Central neuraxial analgesia has been extensively used for labor analgesia and is currently the gold standard technique for pain control in obstetrics.

The aim of the study will be to compare the role of dexmedetomidine or fentanyl as additives to epidural levobupivacaine in painless vaginal delivery as regard maternal analgesia and safety.

Enrollment

90 patients

Sex

All

Ages

21 to 41 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • American Society of Anesthesiologists (ASA) physical status class II and III,
  • Full term pregnancy.

Exclusion criteria

  • Patient refusal to epidural analgesia,
  • Contraindications of epidural analgesia (coagulopathy, local infection, vertebral deformity hypersensitivity to levobupivacaine, dexmedetomidine or fentanyl, hemodynamic instability, severe aortic or mitral stenosis),
  • Cardiac diseases
  • Severe pre-eclampsia,
  • Breech presentations
  • Antepartum hemorrhage
  • Cephalopelvic disproportion
  • Body mass index ≥40 kg/m2.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 3 patient groups

Group C (Control group)
Active Comparator group
Description:
pidural analgesia with levobupivacaine alone
Treatment:
Drug: levobupivacaine
Group D (Dexmedetomidine group)
Experimental group
Description:
Epidural analgesia with levobupivacaine and dexmedetomidine
Treatment:
Drug: Dexmedetomidine
Drug: levobupivacaine
Group F (Fentanyl group)
Experimental group
Description:
Epidural analgesia with levobupivacaine and fentanyl
Treatment:
Drug: levobupivacaine
Drug: Fentanyl

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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