The optimal concentration of bupivacaine and levobupivacaine for labour pain relief with patient-controlled epidural analgesia

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614001033639
• Date of registration: 25/09/2014
• Prospective Registration: Yes
• Primary sponsor: Kestutis Rimaitis
• Public title: The optimal concentration of bupivacaine and levobupivacaine for labour pain relief with patient-controlled epidural analgesia
• Scientific title: The effect of different concentrations of bupivacaine and levobupivacaine on labour pain for primiparas, using patient-controlled epidural analgesia: Randomized controlled trial
• Date of first enrolment: 01/10/2014
• Target sample size: 504
• Recruitment status: Stopped early
• URL: https://anzctr.org.au/ACTRN12614001033639.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Phase 4

Countries of recruitment

Lithuania

Contacts

• Name: Dr Vilda Baliuliene

• Name: Dr Vilda Baliuliene

Key inclusion & exclusion criteria

Inclusion criteria: Primiparas, gestational age >37 and <41 weeks, who had requested for epidural analgesia during labor, cervical dilatation <5 cm, the beginning of labor is spontaneous. American Society of Anaesthesiologists (ASA) physical status 1 or 2;
Uncomplicated, vertex-presenting, singleton pregnancy.
Exclusion criteria: Arterial hypertension, preeclampsia, eclampsia.
Diabetes mellitus (gestational, type 1 and type 2).
There are contraindications for epidural analgesia due to haemodynamic, infectious, allergic, neurological or hematological reasons.
Multiple pregnancy, multiparity, induced labour
Body Mass Index >40 kg/m2, height less than 150 cm.
Fetal growth restrictions or other fetal abnormalities.

Age minimum: 18 Years
Age maximum: 40 Years
Gender: Females

Health Condition(s) or Problem(s) studied

Reproductive Health and Childbirth - Childbirth and postnatal care

Anaesthesiology - Pain management

Labour pain;
Labour pain

Intervention(s)

Intervention: patient controlled epidural analgesia
Mode of administration: Initial dose 10 ml; after 15 minutes from initial dose start of the background infusion 10 ml/h, bolus dose 2 ml, lockout interval 15 min.
If necessary additional 5 ml bolus, by anesthesiologist.
The same combination of drugs (one of the possible arms) is used in all steps of analgesia for the same patient.
Duration: until baby delivery
Drugs: opioid (fentanyl 2mcg/ml) and local anesthetic (bupivacaine or levobupivacaine)
Possible concentrations of local anesthetic: 0.0625% (0.625 mg/ml), 0.1% (1 mg/ml), 0.125% (1.25 mg/ml)
Intervention arms are six:
Arm 1 - bupivacaine 0.0625% (0.625 mg/ml)+fentanyl 2mcg/ml.
Arm 2 - levobupivacaine 0.0625% (0.625 mg/ml)+fentanyl 2mcg/ml
Arm 3 - bupivacaine 0.1% (1 mg/ml)+fentanyl 2mcg/ml
Arm 4 - levobupivacaine 0.1% (1 mg/ml)+fentanyl 2mcg/ml
Arm 5 - bupivacaine 0.125% (1.25 mg/ml)+ fentanyl 2mcg/ml
Arm 6 - levobupivacaine 0.125% (1.25 mg/ml)+fentanyl 2mcg/ml
Initial dose is infused directly through epidural catheter; then the patient controlled epidural analgesia device is connected and all drugs are infused using it.

Primary Outcome(s)

Total consumption of local anesthetic in milligrams. patient-controlled epidural enalgesia pump shows, and saves in memory, how many milliliters of drug mixture are delivered. Plus 10 ml for initial dose. [From beginning of epidural analgesia until after baby delivery, when patient-controlled epidural analgesia pump is turned off]

Number of epizodes of breakthrough pain, Visual Analogue Scale scores>6[From start of patient-controlled epidural analgesia until straight after baby delivery]

Satisfaction with labour pain treatment as assessed using a Visual Analogue Scale[within 72 hours after baby delivery]

Secondary Outcome(s)

Body temperature in degrees Celsius, measured with digital thermometer in armpit[Every hour from the intitiation of labour analgesia until baby delivery]

The incidence of adverse events:
Active questions during every visit of anesthesiologist to delivery room or patient complaints to anesthesiologist, gynecologist or midwife during labour.
Itching: yes - 1 point, no - 0 points.
Nausea and vomiting: nausea - 1 point, vomiting - 2 points, no nausea or vomiting - 0 points.
Urinary retention: yes - 1 point, no - 0 points[Every time moment from the start of patient-controlled epidural analgesia until baby delivery]

Labour pain as assessed using a Visual Analogue Scale[First two hours after start of patient-controlled epidural analgesia every 15 minutes, then every hour until baby delivery]

Motor block as assessed using Bromage score[First two hours after start of patient-controlled epidural analgesia every 15 minutes, then every hour until baby delivery]

Number of fetal bradicardia epizodes, monitoring cardiotocogram during labour[From start of patient-controlled epidural analgesia until straight after baby delivery]

Baby condition in Apgar scores[1 and 5 minutes after delivery]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Lithuanian University of Sciences Kaunas clinics

Secondary Sponsor(s)

Lithuanian Council of Sciences

Ethics review

Status: Approved
Approval date:
Contact:

Kaunas Regional Ethics Committee of Biomedical Reasearches