Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor

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

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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