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Different Epidural Initiation Volumes

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
5 mL epidural initiation volume (bupivacaine + fentanyl)
10 mL epidural initiation volume (bupivacaine + fentanyl)
20 mL epidural initiation volume (bupivacaine + fentanyl)
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring cesarean section, combined spinal epidural anesthesia, patient controlled epidural analgesia, postoperative pain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiology risks classification II
  • Term pregnant

Exclusion Criteria:

  • Multiple pregnancy
  • Diabetes mellitus
  • Hypertension
  • Coagulopathy
  • Severe cardiac, neurological and pulmonary disease
  • Allergy to the study drugs
  • Difficulty in understanding the use of the patient controlled analgesia device

Sites / Locations

  • Inonu University Turgut Ozal Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group 5

Group 10

Group 20

Arm Description

5 mL epidural initiation volume (bupivacaine + fentanyl)

10 mL epidural initiation volume (bupivacaine + fentanyl)

20 mL epidural initiation volume (bupivacaine + fentanyl)

Outcomes

Primary Outcome Measures

Change in postoperative pain scores
Visual analog scale

Secondary Outcome Measures

First analgesic demand time
Time to first analgesic requirement (first patient controlled epidural analgesic demand time)
The number of analgesic requirement
The number of patient controlled epidural analgesic requirement per hour
Morphine requirement
Intravenous morphine administration

Full Information

First Posted
May 9, 2017
Last Updated
May 16, 2017
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT03156322
Brief Title
Different Epidural Initiation Volumes
Official Title
Effects of Different Epidural Initiation Volumes on Postoperative Analgesia in Cesarean Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 1, 2016 (Actual)
Study Completion Date
January 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to compare the effect of different epidural initiation volumes on postoperative pain scores, local anesthetic requirements, and motor block in patients who undergo patient controlled epidural analgesia for postoperative pain after cesarean section.
Detailed Description
90 minutes after combined epidural spinal catheter insertion, three different volumes (5 mL, 10 mL, and 20 mL) are administered with a patient-controlled epidural analgesia (PCEA) device through the epidural catheter. For each group, 0.625% bupivacain + 2 μg/mL fentanyl, is administered. The visual analog scale, first analgesic demand time, the number of PCEA requirement per hour, morphine requirement, nausea-vomiting, itching, motor block, hypotension, and total consumed analgesic, and ephedrine amounts of the patients are recorded in the recovery room and at postoperative 2, 4, 6, 12 hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
cesarean section, combined spinal epidural anesthesia, patient controlled epidural analgesia, postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 5
Arm Type
Active Comparator
Arm Description
5 mL epidural initiation volume (bupivacaine + fentanyl)
Arm Title
Group 10
Arm Type
Active Comparator
Arm Description
10 mL epidural initiation volume (bupivacaine + fentanyl)
Arm Title
Group 20
Arm Type
Active Comparator
Arm Description
20 mL epidural initiation volume (bupivacaine + fentanyl)
Intervention Type
Drug
Intervention Name(s)
5 mL epidural initiation volume (bupivacaine + fentanyl)
Other Intervention Name(s)
Bupivacaine(Marcaine 0.5%), Fentanyl(Talinat 0.5mg/10mL)
Intervention Description
5 mL 0.625% bupivacaine + 2 μg/mL fentanyl solution is administered from epidural catheter
Intervention Type
Drug
Intervention Name(s)
10 mL epidural initiation volume (bupivacaine + fentanyl)
Other Intervention Name(s)
Bupivacaine(Marcaine 0.5%), Fentanyl(Talinat 0.5mg/10mL)
Intervention Description
10 mL 0.625% bupivacaine + 2 μg/mL fentanyl solution is administered from epidural catheter
Intervention Type
Drug
Intervention Name(s)
20 mL epidural initiation volume (bupivacaine + fentanyl)
Other Intervention Name(s)
Bupivacaine(Marcaine 0.5%), Fentanyl(Talinat 0.5mg/10mL)
Intervention Description
20 mL 0.625% bupivacaine + + 2 μg/mL fentanyl solution is administered from epidural catheter
Primary Outcome Measure Information:
Title
Change in postoperative pain scores
Description
Visual analog scale
Time Frame
up to 12 hours after cesarean delivery
Secondary Outcome Measure Information:
Title
First analgesic demand time
Description
Time to first analgesic requirement (first patient controlled epidural analgesic demand time)
Time Frame
up to 12 hours after cesarean delivery
Title
The number of analgesic requirement
Description
The number of patient controlled epidural analgesic requirement per hour
Time Frame
up to 12 hours after cesarean delivery
Title
Morphine requirement
Description
Intravenous morphine administration
Time Frame
up to 12 hours after cesarean delivery
Other Pre-specified Outcome Measures:
Title
Side effects associated with epidural analgesia
Description
Nausea-vomiting, itching, motor block, hypotension
Time Frame
up to 12 hours after cesarean delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiology risks classification II Term pregnant Exclusion Criteria: Multiple pregnancy Diabetes mellitus Hypertension Coagulopathy Severe cardiac, neurological and pulmonary disease Allergy to the study drugs Difficulty in understanding the use of the patient controlled analgesia device
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmut Durmus, Prof
Organizational Affiliation
Prof Dr
Official's Role
Study Chair
Facility Information:
Facility Name
Inonu University Turgut Ozal Medical Center
City
Malatya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25425774
Citation
Sng BL, Woo D, Leong WL, Wang H, Assam PN, Sia AT. Comparison of computer-integrated patient-controlled epidural analgesia with no initial basal infusion versus moderate basal infusion for labor and delivery: A randomized controlled trial. J Anaesthesiol Clin Pharmacol. 2014 Oct;30(4):496-501. doi: 10.4103/0970-9185.142842.
Results Reference
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Different Epidural Initiation Volumes

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