ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12614001033639

Ethics application status

Approved

Date submitted

2/09/2014

Date registered

25/09/2014

Date last updated

30/01/2018

Type of registration

Prospectively registered

Titles & IDs

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

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1160-0268

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Labour pain

Condition category

Condition code

Anaesthesiology

Pain management

Reproductive Health and Childbirth

Childbirth and postnatal care

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

There are no control group that receives no analgesia at all. The control groups are:
Arm 1 - bupivacaine 0.0625% (0.625 mg/ml)+fentanyl 2mcg/ml.
Arm 3 - bupivacaine 0.1% (1 mg/ml)+fentanyl 2mcg/ml
Arm 5 - bupivacaine 0.125% (1.25 mg/ml)+ fentanyl 2mcg/ml

Control group

Active

Outcomes

Primary outcome [1]

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.

Timepoint [1]

From beginning of epidural analgesia until after baby delivery, when patient-controlled epidural analgesia pump is turned off

Primary outcome [2]

Number of epizodes of breakthrough pain, Visual Analogue Scale scores>6

Timepoint [2]

From start of patient-controlled epidural analgesia until straight after baby delivery

Primary outcome [3]

Satisfaction with labour pain treatment as assessed using a Visual Analogue Scale

Timepoint [3]

within 72 hours after baby delivery

Secondary outcome [1]

Labour pain as assessed using a Visual Analogue Scale

Timepoint [1]

First two hours after start of patient-controlled epidural analgesia every 15 minutes, then every hour until baby delivery

Secondary outcome [2]

Motor block as assessed using Bromage score

Timepoint [2]

First two hours after start of patient-controlled epidural analgesia every 15 minutes, then every hour until baby delivery

Secondary outcome [3]

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

Timepoint [3]

Every time moment from the start of patient-controlled epidural analgesia until baby delivery

Secondary outcome [4]

Body temperature in degrees Celsius, measured with digital thermometer in armpit

Timepoint [4]

Every hour from the intitiation of labour analgesia until baby delivery

Secondary outcome [5]

Number of fetal bradicardia epizodes, monitoring cardiotocogram during labour

Timepoint [5]

From start of patient-controlled epidural analgesia until straight after baby delivery

Secondary outcome [6]

Baby condition in Apgar scores

Timepoint [6]

1 and 5 minutes after delivery

Eligibility

Key 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.

Minimum age

18 Years

Maximum age

40 Years

Sex

Females

Can healthy volunteers participate?

Yes

Key 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.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation involved contacting the holder of the allocation schedule who was at central administration site

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomization using a computer-generated randomization table

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Power analysis revealed that we need to study 84 patients per group to detect a 25 % difference between total consumption of local anesthetic, with an a-error of 0.05 and beta-error of 0.8. As there are 6 groups we need to enroll 504 patients.
To compare quantitative variables with normal distribution the one-way or two-way or repeated-measures analysis of variance (ANOVA) would be used as appropriate.
The normality of the distribution would be checked with a Kolmogorov-Smirnov test. To compare the quantitative non Gaussian and categorical variables we would use Kruskal-Wallis test.
Chi -square test would be used to test correlations between qualitative data. A post-hoc test would be applied using the Bonferroni method for adjusting for multiple comparisons.
Data would be presented as mean +/- standard deviation, % of group total or median with interquartile range, as appropriate.
p<0.05 would be considered as statistically significant.

Recruitment

Recruitment status

Stopped early

Data analysis

Data analysis is complete

Reason for early stopping/withdrawal

Participant recruitment difficulties

Date of first participant enrolment

Anticipated

15/09/2014

Actual

1/10/2014

Date of last participant enrolment

Anticipated

28/08/2017

Actual

28/08/2017

Date of last data collection

Anticipated

31/08/2017

Actual

31/08/2017

Sample size

Target

504

Accrual to date

Final

235

Recruitment outside Australia

Country [1]

Lithuania

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Lithuanian University of Sciences Kaunas clinics

Address [1]

Eiveniu street. 2, Kaunas city, LT-50009

Country [1]

Lithuania

Primary sponsor type

Individual

Name

Kestutis Rimaitis

Address

Lithuanian University of Sciences Kaunas clinics, Eiveniu street. 2, Kaunas city, LT-50009

Country

Lithuania

Secondary sponsor category [1]

Government body

Name [1]

Lithuanian Council of Sciences

Address [1]

Gediminas avenue 3, Vilnius city, LT- 01103

Country [1]

Lithuania

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Kaunas Regional Ethics Committee of Biomedical Reasearches

Ethics committee address [1]

Eiveniu street. 2, Kaunas city, LT-50009

Ethics committee country [1]

Lithuania

Date submitted for ethics approval [1]

Approval date [1]

04/03/2014

Ethics approval number [1]

BE-2-24

Summary

Brief summary

The goal of the study is to find the optimal, in terms of efficacy and safety, concentration of local anesthetic for Patient-controlled epidural labour pain analgesia. Our hypothesis is that the optimal concentration of local anesthetics for labour pain analgesia should be 0.1%, because we think that the concentration of 0.125% may cause a bigger motor block and lower patient satisfaction, and the pain reducing effect of concentration of 0.0625 % wold not always be satisfactory.
In order to assess the optimal concentration of local anesthetic we use the same drug concentration for initial epidural bolus and later for Patient-controlled epidural analgesia. The strict inclusion and exclusion criteria are chosen in order to purify the contingent. We also include only primiparas because the course of labour and the pattern of pain is different for primiparas and for multiparas.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Kestutis Rimaitis

Address

Lithuanian University of Sciences Kaunas clinics, Eiveniu street. 2, Kaunas city, LT-50009

Country

Lithuania

Phone

+37068725347

Fax

[email protected]

Contact person for public queries

Name

Vilda Baliuliene

Address

Lithuanian University of Sciences Kaunas clinics, Eiveniu street. 2, Kaunas city, LT-50009

Country

Lithuania

Phone

+37067267569

Fax

[email protected]

Contact person for scientific queries

Name

Vilda Baliuliene

Address

Lithuanian University of Sciences Kaunas clinics, Eiveniu street. 2, Kaunas city, LT-50009

Country

Lithuania

Phone

+37067267569

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The optimal concentration of bupivacaine and levobupivacaine for labor pain management using patient-controlled epidural analgesia: a double-blind, randomized controlled trial.	2018	https://dx.doi.org/10.1016/j.ijoa.2018.05.002

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically