Epidural Tap in Labor Analgesia FOR LABOR ANALGESIA
Primary Purpose
Labor Pain
Status
Recruiting
Phase
Phase 1
Locations
Turkey
Study Type
Interventional
Intervention
Dolantin
Paracetamol
Sponsored by
About this trial
This is an interventional supportive care trial for Labor Pain focused on measuring labor analgesia, dural tap, concentration
Eligibility Criteria
Inclusion Criteria:
- ASA II primigravid women
- with cervical dilatation between 4-6 cm, demanding epidural analgesia during spontaneous vaginal delivery
Exclusion Criteria:
Participants with pregnancy-related diseases
- gestational hypertension
- gestational diabetes
- preeclampsia/ celmpsia
contraindications for neuraxial block
- infection
- coagulation disorders
- severe hypovolemia
- sepsis
- neurological deficit
- cardiac valve stenosis or hypertrophic obstructive cardiomyopathy
- Women with fetal malpresentation and fetal anomaly
Sites / Locations
- Istanbul Medipol UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
High concentration
Low concentration
Arm Description
Epidural analgesia with 20 mL of 0.125% bupivacaine + 2 mcg/mL fentanyl solution
Epidural analgesia with 20 mL of 0.0625% bupivacaine + 2 mcg/mL fentanyl solution
Outcomes
Primary Outcome Measures
Change the need of bupivacaine for epidural analgesia.
primary aim of this study is to achieve VAS scores equal to or below 4 via different bupivacaine concentrations
Secondary Outcome Measures
Complication comparison
measure the number of treatment related complications and compare these measurements between the groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05499234
Brief Title
Epidural Tap in Labor Analgesia FOR LABOR ANALGESIA
Official Title
Effects of Different Local Anesthetic Concentrations With Epidural Tap Method for Labor Analgesia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
September 15, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The dural epidural tap method is performed by creating a dural perforation with a spinal needle placed through epidural needle, followed by placement of a catheter into the epidural space. No medications are administered through spinal needle. This prospective, randomized study includes 70 ASA II primigravid women with cervical dilatation between 4-6 cm and demanding epidural analgesia during spontaneous vaginal delivery.In the first group, 20 mL of 0.125% bupivacaine + 2 mcg/mL fentanyl solution and in the second group, 20 mL of 0.0625% bupivacaine + 2 mcg/mL fentanyl solution was administered as the first dose through the epidural catheter. Then, the visual analog scale (VAS) score was aimed to be below 4 in both groups.
Detailed Description
This prospective, randomized study includes 70 ASA II primigravid women with cervical dilatation between 4-6 cm and demanding epidural analgesia during spontaneous vaginal delivery. Participants with pregnancy-related diseases (such as gestational hypertension, gestational diabetes, preeclampsia) and contraindications for neuraxial block (infection, coagulation disorder, severe hypovolemia, sepsis, neurological deficit, cardiac valve stenosis or hypertrophic obstructive cardiomyopathy) will be excluded from the study. Women with fetal malpresentation and fetal anomaly will also be excluded.
Participants will randomly be divided into 2 equal groups. Immediately before epidural placement, subjects will be marked a VAS score during an active contraction. All subjects will have an intravenous catheter placed and be monitored with NST, noninvasive blood pressure and pulse oximetry.
The epidural space will be identified by a loss of resistance technique to saline. CSF flow will be observed at L3-L4 or L4-L5 level by puncturing the dura with a 27 G needle before inserting the epidural catheter. A combined spinal epidural set with 18 G Tuohy needle will be used in both groups. In the first group, 20 mL of 0.125% bupivacaine + 2 mcg/mL fentanyl solution and in the second group, 20 mL of 0.0625% bupivacaine + 2 mcg/mL fentanyl solution will be administered as the first dose through the epidural catheter. Then, the visual analog scale (VAS) score will be aimed to be below 4 in both groups. Patients with a VAS score of 4 or higher 15 minutes after the first dose received, an additional 10 mL dose of the same solution will be given. An additional 10 mL dose also will be administered when the VAS score is 4 or higher until crowning.
Before the epidural catheter placed; age, weight, height, blood pressure of the participants, gestational week, use of oxytocin during delivery, cervical dilatation amount before the procedure and fetal heart rate will be recorded. After each dose of administration, whether maternal hypotension, fetal bradycardia, pruritus, nausea-vomiting or motor block development will be monitored. The total amount of drug administered through the epidural catheter, the time between applications, and the number of bolus doses administered will also be recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
labor analgesia, dural tap, concentration
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
70 ASA II primigravid women with cervical dilatation between 4-6 cm and demanding epidural analgesia during spontaneous vaginal delivery
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Participants and the medical staff administrating epidural drugs will not be told about the concentration. Because volumes will be same, they would not predict which group.
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High concentration
Arm Type
Experimental
Arm Description
Epidural analgesia with 20 mL of 0.125% bupivacaine + 2 mcg/mL fentanyl solution
Arm Title
Low concentration
Arm Type
Experimental
Arm Description
Epidural analgesia with 20 mL of 0.0625% bupivacaine + 2 mcg/mL fentanyl solution
Intervention Type
Drug
Intervention Name(s)
Dolantin
Other Intervention Name(s)
Meperidin
Intervention Description
If VAS score is more than 4 even after additional dose, use dolantin 1 mg/kg
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
Parol
Intervention Description
If VAS score is more than 4 even after dolantin 1 mg/kg, 10 mg/kg paracetamol IV
Primary Outcome Measure Information:
Title
Change the need of bupivacaine for epidural analgesia.
Description
primary aim of this study is to achieve VAS scores equal to or below 4 via different bupivacaine concentrations
Time Frame
In an hour
Secondary Outcome Measure Information:
Title
Complication comparison
Description
measure the number of treatment related complications and compare these measurements between the groups
Time Frame
2 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ASA II primigravid women
with cervical dilatation between 4-6 cm, demanding epidural analgesia during spontaneous vaginal delivery
Exclusion Criteria:
Participants with pregnancy-related diseases
gestational hypertension
gestational diabetes
preeclampsia/ celmpsia
contraindications for neuraxial block
infection
coagulation disorders
severe hypovolemia
sepsis
neurological deficit
cardiac valve stenosis or hypertrophic obstructive cardiomyopathy
Women with fetal malpresentation and fetal anomaly
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pelin karaaslan, Assoc Prof
Phone
+905057657550
Email
pkaraaslan@medipol.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pınar Uçar
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emine Uzunoğlu
Organizational Affiliation
Medipol University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pelin Karaaslan
Organizational Affiliation
Medipol University
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
State/Province
Bağcılar
ZIP/Postal Code
34700
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huseyin Oz, Professor
Phone
+905327941119
Email
hoz@medipol.edu.tr
First Name & Middle Initial & Last Name & Degree
Emine Uzunoğlu, Assist Prof
First Name & Middle Initial & Last Name & Degree
Pınar Uçar, Resident
First Name & Middle Initial & Last Name & Degree
Pelin Karaaslan, Assoc Prof
12. IPD Sharing Statement
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Epidural Tap in Labor Analgesia FOR LABOR ANALGESIA
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