The Programmed Intermittent Epidural Bolus Adrenaline Study

NCT ID: NCT03043781

Last Updated: 2018-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-20
• Study Completion Date: 2018-09-05

Brief Summary

This study evaluates the use of intermittent epidural boluses compared to continuous infusion in maintaining epidural pain relief in labor.

The medicine solution used contains, in addition to bupivacain and fentanyl, adrenalin in both groups.

Detailed Description

Labor is often painful for the woman going through it, and thus many women choose to have pain relief by an epidural catheter.

This is done by placing a thin plastic catheter in the epidural space in the lower back of the patient, and injecting a medicine solution usually consisting of local anesthesia and opioids.

To ensure an effective pain relief through the labor process, additional medicine solution is injected through the catheter. Traditionally, this is done by a continuous infusion, often with the addition of patient controlled boluses.

In this study the investigators investigate if maintaining the pain relief through programmed hourly intermittent boluses is more effective than continuous infusion. This is done in other studies with promising results, but the difference in this study is the addition of adrenaline to the medicine solution in order to make it more effective.

Conditions

Labor Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intermittent epidural bolus (IEB)

Bolus of 5 ml every hour + patient controlled extra boluses of 5 ml, maximum 3 / hour. Medicine solution is bupivacaine 1 mg/ml, fentanyl 2 mcg/ml, adrenaline 2 mcg/ml.

Group Type: EXPERIMENTAL

Intermittent epidural bolus

Intervention Type: OTHER

Intermittent bolus 5 ml every hour

Continuous epidural infusion (CEI)

Continuous epidural infusion of 5 ml / hour + patient controlled extra boluses of 5 ml, maximum 3 / hour. Medicine solution is bupivacaine 1 mg/ml, fentanyl 2 mcg/ml, adrenaline 2 mcg/ml.

Group Type: ACTIVE_COMPARATOR

Continuous epidural infusion

Intervention Type: OTHER

Continuous infusion, 5 ml/h

Interventions

Continuous epidural infusion

Continuous infusion, 5 ml/h

Intervention Type: OTHER

Intermittent epidural bolus

Intermittent bolus 5 ml every hour

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Pregnant women in labor requesting epidural analgesia
• ASA group 1 and 2
• 0 or 1 previous births
• Must be at least 18 years of age.
• Singleton pregnancy
• Active labor
• Signed informed consent and expected cooperation of the patient

Exclusion Criteria

• Poor communication skills in norwegian or english
• Adverse reactions to local anesthetics or synthetic opioids
• Body height below 150 cm
• Gestational age below 37 weeks, 0 days
• Any contraindication to epidural catheter placement (e.g. patients with coagulopathy, infection in area etc)
• Pre-eclampsia
• Sound reason by the investigator to suspect patient non-compliance (e.g. with use of PCEA)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Akershus

OTHER

Sponsor Role: lead

Responsible Party

Vegard Dahl

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vegard Dahl, MD, Dr. Med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Akershus

Locations

Akershus UH

Lørenskog, Akershus, Norway

Countries

Norway

References

George RB, Allen TK, Habib AS. Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jan;116(1):133-44. doi: 10.1213/ANE.0b013e3182713b26. Epub 2012 Dec 7.

Reference Type: BACKGROUND

PMID: 23223119 (View on PubMed)

Other Identifiers

2015-004397-14

Identifier Type: -

Identifier Source: org_study_id