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Epidural Analgesia During Labour (PIEBvsPCEA)

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ClinicalTrials.gov Identifier: NCT03133091
Recruitment Status : Completed
First Posted : April 28, 2017
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
MARIA BELEN RODRIGUEZ-CAMPOO, Hospital del Río Hortega

Brief Summary:
Randomized single blind trial based on comparing the way the local anesthetic is dosificated during labour. The pain control is evaluated and compared with both dosage techniques (PCEA vs PIEB)using levobupivacaine and fentanyl. The primary objective is to see no differences in pain control(VAS, Visual Analog Scale). The secondary goals are the differences in motor block(Bromage Scale), satisfaction (Likert Scale), the outcome (eutocic, instrumental o cesarean section), second stage of labour time, newborn´s Apgar and pH and total dosis and secondary effects of local anesthetic.

Condition or disease Intervention/treatment Phase
Anesthesia, Obstetrical Analgesia, Epidural Drug: PIEB: Patient Intermittent Epidural Boluses Drug: PCEA: Patient Controlled Epidural Analgesia Phase 3

Detailed Description:
There is a protocol where every healthy primiparous women have the chance to join the study after the explanation and the informed consent is signed. There are blind envelopes with the two kinds of treatment and the investigator only has to follow the protocol.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Epidural Analgesia During Labour Randomized Clinical Trial Comparing Patient Controlled Epidural Analgesia Versus Patient Intermittent Epidural Boluses With Levobupivacaine
Study Start Date : September 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PIEB (Patient Intermittent Epidural Bolus)

PIEB: The boluses are programmed every 30 minutes. The patient can ask for another extra bolus in between if she wishes.

The dosis per hour are equivalent to the PCEA. We make a comparison between PCEA vs PIEB.

Drug: PIEB: Patient Intermittent Epidural Boluses
Each patient were randomized to PIEB (7 ml bolus every 30 minutes, with extra boluses (PCEA) of 6 ml every 20 minutes) or PCEA (5 ml in continuous perfussion + PCEA of 5 ml every 15 minutes).

Active Comparator: PCEA (Patient continuous Epidural Analgesia)

PCEA: There is a continuous infusion and the patient can order extra boluses every 15 minutes.

The dosis per hour are equivalent to the other arm to the PIEB. We make a comparison between PCEA vs PIEB.

Drug: PCEA: Patient Controlled Epidural Analgesia
Each patient were randomized to PIEB (7 ml bolus every 30 minutes, with extra boluses (PCEA) of 6 ml every 20 minutes) or PCEA (5 ml in continuous perfussion + PCEA of 5 ml every 15 minutes).




Primary Outcome Measures :
  1. VAS [ Time Frame: 4 times after epidural block: previous, 1 hour after, 2 hours after, 15 minutes after delivery ]
    Change from baseline in Visual Analog Scale


Secondary Outcome Measures :
  1. Satisfaction (Likert Scale) [ Time Frame: 1 hour after delivery ]
    1 (very satisfied), 2 (satisfied), 3 (no comments), 4 (not very satisfied), 5 (not satisfied at all)

  2. Bromage Scale [ Time Frame: 15 minutes after Epidural Block and 1 hour after epidural block ]
  3. Labour Outcome [ Time Frame: Delivery ]
    Eutocic

  4. Labour Outcome [ Time Frame: Delivery ]
    instrumental

  5. Labour Outcome [ Time Frame: Delivery ]
    cesarean section

  6. Expulsive time [ Time Frame: From 10 cm of dilatation until delivery ]
  7. Apgar at birth [ Time Frame: 1 minute after birth ]
    Apgar measured in 1 minute

  8. Apgar at birth [ Time Frame: 5 minutes after birth ]
    Apgar measured in 5 minutes

  9. fetal pH at birth [ Time Frame: 0 minutes after delivery ]
    0 minutes after delivery

  10. Total Dosis of Levobupivacaine [ Time Frame: 0 minutes after delivery ]
    miligrams



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 20- 40 years-old women
  • Primiparous women
  • Dilatation 3- 7 cm
  • No risk illnesses for epidural block
  • No risk pregnancy
  • Signed informed consent

Exclusion Criteria:

  • Illnesses which are a risk for pregnancy
  • Multiparous women
  • Contraindicated diseases for epidural block
  • Women who can not understand the procedure
  • Women who do not want to sign the informed consent
  • Patients with drug´s allergy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03133091


Locations
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Spain
Hospital Universitario Rio Hortega
Valladolid, Spain, 47012
Sponsors and Collaborators
Hospital del Río Hortega
Investigators
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Study Director: M BELEN RODRIGUEZ-CAMPOO Resident
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: MARIA BELEN RODRIGUEZ-CAMPOO, PhD title in Medicine and Surgery, Hospital del Río Hortega
ClinicalTrials.gov Identifier: NCT03133091    
Other Study ID Numbers: 290587
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by MARIA BELEN RODRIGUEZ-CAMPOO, Hospital del Río Hortega:
PIEB
PCEA
LEVOBUPIVACAINE
Additional relevant MeSH terms:
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Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases