Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000976785
Ethics application status
Approved
Date submitted
7/03/2022
Date registered
11/07/2022
Date last updated
11/07/2022
Date data sharing statement initially provided
11/07/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does dural puncture epidural improve quality of labor epidural analgesia?
Randomized single- blinded controlled study
Scientific title
Does dural puncture epidural improve quality of labor epidural analgesia in nulliparous parturients in active labor?
Randomized single- blinded controlled study
Secondary ID [1] 306254 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inadequate and inefficient labor epidural analgesia 325160 0
Vaginal delivery 325874 0
Condition category
Condition code
Anaesthesiology 322566 322566 0 0
Pain management
Reproductive Health and Childbirth 323185 323185 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lumbar epidural puncture was performed with an 18-gauge Tuohy needle, at the level between third and fourth or fourth and fifth lumbar vertebra. Patient was positioned in sitting position for the procedure. Epidural space was identified by using loss of resistance technique with syringe containing 10 ml of saline. Afterwards, atraumatic Whitacre needle, 27-gauge, 12 mm of length was inserted through epidural needle until free flow of cerebrospinal fluid (CSF) was obtained. The spinal needle was then withdrawn without administration of any medication intrathecally. Epidural catheter (19 gauge) was inserted 5-6 cm into epidural space. Administration of test dose, containing of 3 ml of 2% lidocaine was preceded by negative aspiration of blood or CSF. After the test dose came negative, epidural analgesia was initiated with a 10 ml bolus of 0,125% bupivacaine administered over 5 minutes. As analgetic adjuvants we used fentanyl 1,5 mcg/ml according to local institutional protocol. Upon completion of epidural bolus and attainment of adequate analgesia, continuous epidural infusion of 0,08% bubivacaine mixed with fentanyl 1.5 mcg/ml was started at 8 ml per hour. In case of inadequate epidural analgesia (defined as NRS>3) additional boluses of local anesthetic mixture (0.125% bupivacaine and fentany 1.5 mcg per ml, overall volume of single bolus is 10 ml) wil be administered via epidural catheter. Overall volume of drugs administered via epidural catheter should not exceed 25 ml during an hour. Epidural catheter placement and administration of drug via epidural catheter was performed by anesthesiologist in hospital delivery room. After completion of third stage of labour, epidural catheter will be removed. Adequacy of epidural analgesia and neurological assessment of parturients will be recorded in one hour intervals.
Intervention code [1] 322790 0
Treatment: Devices
Intervention code [2] 323264 0
Treatment: Drugs
Comparator / control treatment
In control group standard epidural technique was applied, without dural puncture by atraumatic Whitacre spinal needle.
Lumbar epidural puncture was performed with an 18-gauge Tuohy needle, at the level between third and fourth or fourth and fifth lumbar vertebra. Patient was positioned in sitting position for the procedure. Epidural space was identified by using loss of resistance technique with syringe containing 10 ml of saline. Epidural catheter (19 gauge) was inserted 5-6 cm into epidural space. Administration of test dose, containing of 3 ml of 2% lidocaine was preceded by negative aspiration of blood or CSF. After the test dose came negative, epidural analgesia was initiated with a 10 ml bolus of 0,125% bupivacaine administered over 5 minutes. As analgetic adjuvants we used fentanyl 1,5 mcg/ml and epinephrine 1,5 mcg/ml according to local institutional protocol After effective analgesia had been achieved, continuous epidural infusion of 0,08% bubivacaine mixed with fentanyl 2 mcg/ml and was started at 8 ml per hour. In case of inadequate epidural analgesia (defined as NRS >3 ) additional boluses of 0,125% bupivacaine of 10 ml will be administered via epidural catheter. Overall volume of drugs administered via epidural catheter should not exceed 25 ml during an hour. Epidural catheter placement and administration of drug via epidural catheter was performed by anesthesiologist in hospital delivery room.
Control group
Active

Outcomes
Primary outcome [1] 330367 0
Onset of adequate epidural analgesia (EA) defined as numeric pain rating score (NPRS)<=3 during uterine contraction after epidural catheter insertion and administration of first bolus of local anesthetic via epidural catheter.





Timepoint [1] 330367 0
NPRS assessment at baseline (before epidural catheter insertion) and at 5, 10 and 15 min after adminstration of first bolus.
Primary outcome [2] 330935 0
Number of additional epidural top-ups along continuous epidural infusion of local anesthetic mixture as assessed by accessing patient electronic medical records.



Timepoint [2] 330935 0
NPRS was assessed every hour after first bolus (zero timepoint) until delivery or earlier upon parturients' request.
Secondary outcome [1] 405971 0
Incidence of emergent cesarean section assessed by accessing patient electronic medical records.
Timepoint [1] 405971 0
nil
Secondary outcome [2] 408146 0
Incidence of instrumented vaginal delivery assessed by accessing patient electronic medical records.
Timepoint [2] 408146 0
nil
Secondary outcome [3] 411728 0
Incidence of side effects related to neuroaxial procedure (arterial hypotension, postdural puncture headache, low back pain, nerve injury, pruritus) assesed by noninvasive blood pressure measurement, neurologic status assessment by anesthesiologist and by self-report.
Timepoint [3] 411728 0
Neurological assessment was done before first bolus and in an hour intervals until delivery, as well as the noninvasiveblood pressure measurement.. All participants were visited on postpartum day 1 by the member of study team who assesssed the presence of headache, low back pain, nerve injury.

Eligibility
Key inclusion criteria
Healthy nulliparous parturients at 38 to 42 weeks of gestation, requesting epidural analgesia.
Patients who met enrollment criteria were aged 18 years or more in active labor with cervical dilatation less than 6 cm at the moment of epidural insertion.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Preeclampsia, eclampsia, contraindications for neuroaxial anesthesia (coagulopathies, infection at puncture site, aortic valve stenosis, central nervous system disorders)

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Kolmogorov-Smirnov test will be deployed to test normality of distribution for quantitative data. Dependent on type of distribution, parametric or nonparametric tests will be used for comparison. Comparison of nominal data will be done by chi square test. Mann-Whitney U test will be applied for ordinal data as well as for continuous data with asymmetrical distribution. Student's t test will be used for continuous data with normal distribution. p value less than 0.05 is considered statistically significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/02/2022
Date of last participant enrolment
Anticipated
29/07/2022
Actual
Date of last data collection
Anticipated
29/07/2022
Actual
Sample size
Target
76
Accrual to date
30
Final
Recruitment outside Australia
Country [1] 24550 0
Croatia
State/province [1] 24550 0
Zagreb

Funding & Sponsors
Funding source category [1] 310601 0
Hospital
Name [1] 310601 0
University Hospital Centre Sestre Milosrdnice
Country [1] 310601 0
Croatia
Primary sponsor type
Individual
Name
Iva Pažur
Address
University Hospital Centre Sestre Milosrdnice, Department of Anaesthesiology and Intensive Medicine, Vinogradska street 29, 10000 Zagreb.
Country
Croatia
Secondary sponsor category [1] 311794 0
None
Name [1] 311794 0
none
Address [1] 311794 0
none
Country [1] 311794 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310206 0
Ethical Committee of University Hospital Clinical Centre Sestre Milosrdnice
Ethics committee address [1] 310206 0
Ethics committee country [1] 310206 0
Croatia
Date submitted for ethics approval [1] 310206 0
01/10/2020
Approval date [1] 310206 0
05/11/2020
Ethics approval number [1] 310206 0
003-06/20-03/023

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116862 0
Dr Iva Pažur
Address 116862 0
University Hospital Center Sestre Milosrdnice, Department of Anesthesiology and Intensive Medicine, Vinogradska street 29, 10000 Zagreb
Country 116862 0
Croatia
Phone 116862 0
+385 91 6050 924
Fax 116862 0
Email 116862 0
[email protected]
Contact person for public queries
Name 116863 0
Iva Pažur
Address 116863 0
University Hospital Center Sestre Milosrdnice, Department of Anesthesiology and Intensive Medicine, Vinogradska street 29, 10000 Zagreb
Country 116863 0
Croatia
Phone 116863 0
+385 91 6050 924
Fax 116863 0
Email 116863 0
[email protected]
Contact person for scientific queries
Name 116864 0
Iva Pažur
Address 116864 0
University Hospital Center Sestre Milosrdnice, Department of Anesthesiology and Intensive Medicine, Vinogradska street 29, 10000 Zagreb
Country 116864 0
Croatia
Phone 116864 0
+385 91 6050 924
Fax 116864 0
Email 116864 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.