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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] 285252 0
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 292894 0
Condition category
Condition code
Anaesthesiology 293185 293185 0 0
Pain management
Reproductive Health and Childbirth 293320 293320 0 0
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] 290134 0
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] 293052 0
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] 293052 0
From beginning of epidural analgesia until after baby delivery, when patient-controlled epidural analgesia pump is turned off
Primary outcome [2] 293053 0
Number of epizodes of breakthrough pain, Visual Analogue Scale scores>6
Timepoint [2] 293053 0
From start of patient-controlled epidural analgesia until straight after baby delivery
Primary outcome [3] 293054 0
Satisfaction with labour pain treatment as assessed using a Visual Analogue Scale
Timepoint [3] 293054 0
within 72 hours after baby delivery
Secondary outcome [1] 310244 0
Labour pain as assessed using a Visual Analogue Scale
Timepoint [1] 310244 0
First two hours after start of patient-controlled epidural analgesia every 15 minutes, then every hour until baby delivery
Secondary outcome [2] 310245 0
Motor block as assessed using Bromage score
Timepoint [2] 310245 0
First two hours after start of patient-controlled epidural analgesia every 15 minutes, then every hour until baby delivery
Secondary outcome [3] 310246 0
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] 310246 0
Every time moment from the start of patient-controlled epidural analgesia until baby delivery
Secondary outcome [4] 310247 0
Body temperature in degrees Celsius, measured with digital thermometer in armpit
Timepoint [4] 310247 0
Every hour from the intitiation of labour analgesia until baby delivery
Secondary outcome [5] 310251 0
Number of fetal bradicardia epizodes, monitoring cardiotocogram during labour
Timepoint [5] 310251 0
From start of patient-controlled epidural analgesia until straight after baby delivery
Secondary outcome [6] 310252 0
Baby condition in Apgar scores
Timepoint [6] 310252 0
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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6332 0
Lithuania
State/province [1] 6332 0

Funding & Sponsors
Funding source category [1] 289888 0
Hospital
Name [1] 289888 0
Lithuanian University of Sciences Kaunas clinics
Address [1] 289888 0
Eiveniu street. 2, Kaunas city, LT-50009
Country [1] 289888 0
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] 288568 0
Government body
Name [1] 288568 0
Lithuanian Council of Sciences
Address [1] 288568 0
Gediminas avenue 3, Vilnius city, LT- 01103
Country [1] 288568 0
Lithuania

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291611 0
Kaunas Regional Ethics Committee of Biomedical Reasearches
Ethics committee address [1] 291611 0
Eiveniu street. 2, Kaunas city, LT-50009
Ethics committee country [1] 291611 0
Lithuania
Date submitted for ethics approval [1] 291611 0
Approval date [1] 291611 0
04/03/2014
Ethics approval number [1] 291611 0
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 51078 0
A/Prof Kestutis Rimaitis
Address 51078 0
Lithuanian University of Sciences Kaunas clinics, Eiveniu street. 2, Kaunas city, LT-50009
Country 51078 0
Lithuania
Phone 51078 0
+37068725347
Fax 51078 0
Email 51078 0
kestutis.rimaitis@kaunoklinikos.lt
Contact person for public queries
Name 51079 0
Dr Vilda Baliuliene
Address 51079 0
Lithuanian University of Sciences Kaunas clinics, Eiveniu street. 2, Kaunas city, LT-50009
Country 51079 0
Lithuania
Phone 51079 0
+37067267569
Fax 51079 0
Email 51079 0
vilda.cesnovaite@gmail.com
Contact person for scientific queries
Name 51080 0
Dr Vilda Baliuliene
Address 51080 0
Lithuanian University of Sciences Kaunas clinics, Eiveniu street. 2, Kaunas city, LT-50009
Country 51080 0
Lithuania
Phone 51080 0
+37067267569
Fax 51080 0
Email 51080 0
vilda.cesnovaite@gmail.com

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary