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OpenTrials
Completed

NCT Number: NCT02510287

A Comparison of Epidural Analgesia: Continuous Infusion Versus Programmed Intermittent Boluses

The analgesic approach in labor can be done in different ways, among which the neuraxial approach has shown the best analgesic results and fetal outcomes. Currently, programmed epidural intermittent bolus has been included in the neuraxial approach for a better distribution of the solution into the epidural space as compared with the continuous infusion strategy. In this study, the investigators seek to compare both strategies in 132 laboring women.

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Key information

Conditions

Labor Pain Agnosia Behavior Health Behavior Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Patient Satisfaction Perceptual Disorders Signs and Symptoms Treatment Adherence and Compliance

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Fundación Santa Fe

Bogotá, Bogota D.C., Colombia

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • At term pregnancy
  • Laboring patients requiring epidural analgesia

Exclusion criteria

  • American Society of Anesthesiologists physical status > or equal than 3
  • allergy to local anesthesics
  • Neuraxial contraindications
  • Hemodynamic instability
  • Systemic disease such as diabetes mellitus or hypertension
  • Chronic usage of analgesics
  • Disease associated to pregnancy such as gestational diabetes, preeclampsia, fetal malformations among others

Treatment and study plan

Bupivacaine and Fentanyl Initial Dose

Drug

10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution)

Bupivacaine and Fentanyl: Continuous Epidural Infusion

Drug

0.1% bupivacaine and fentanyl 2 mcg / ml (8-12 ml / hour)

Bupivacaine and Fentanyl: Programmed Intermittent Epidural Bolus

Drug

A 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12ml) bolus will be administered each hour at a rate of 500ml/hour

Rescue Bolus

Drug

Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered.

Lidocaine

Drug

If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered.

Primary outcomes

  1. Pain level in laboring women measured by the Numeric Analog Scale

    Time frame: one year

    to compare pain level in each arm once epidural analgesia is applied until birth

Sponsors and collaborators

Lead sponsor

Fundación Santa Fe de Bogota

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 29, 2015
Registry last updated
May 20, 2016

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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