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NCT Number: NCT04397406

Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor

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.

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Key information

Conditions

Epidural Analgesia Dexmedetomidine Fentanyl Levobupivacaine Painless Labor

Age range

21 year–41 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tanta University Hospitals

Tanta, Gharbia Governorate, 31527, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levobupivacaine

Drug

The patients will receive 15 ml of 0.125% levobupivacaine.

Dexmedetomidine

Drug

The patients will receive 13 ml of 0.125% levobupivacaine and 0.5μg/kg dexmedetomidine diluted in 2 ml saline.

Fentanyl

Drug

The patients will receive 13 ml of 0.125% levobupivacaine and 25μg fentanyl diluted in 2 ml saline.

Primary outcomes

  1. Duration of maternal analgesia

    Time frame: 24 hours after epidural injection

    Duration of analgesia will be assessed by measuring the time between the onset of sensory block and return of pain sensation. If the block is inadequate or the patient has pain, a top up dose of 8 mL of the study medication and local anesthetic will be given when visual analogue scale (VAS) will be ≥ 4.

    The pain relief will be assessed by the visual analogue scale (VAS) from 0 to 10 (0: no pain, 1-3: mild pain, 4-7: moderate pain, > 7: severe pain).

Secondary outcomes

  1. Onset of maternal analgesia.

    Time frame: One hour after epidural injection

    The onset of analgesia will be defined as the time taken from drug administration to visual analogue scale (VAS) <3.

  2. Complications of drugs of epidural technique

    Time frame: 24 hours after epidural injection

    Drugs: Sedation, Bradycardia Epidural anesthesia (including nausea, vomiting, backache and fever)

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Role of Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor: A Double Blind Randomized Controlled Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 21, 2020
Registry last updated
Mar 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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