Different Epidural Initiation Volumes

NCT ID: NCT03156322

Last Updated: 2017-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2017-01-01

Brief Summary

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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

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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.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 5

5 mL epidural initiation volume (bupivacaine + fentanyl)

Group Type ACTIVE_COMPARATOR

5 mL epidural initiation volume (bupivacaine + fentanyl)

Intervention Type DRUG

5 mL 0.625% bupivacaine + 2 μg/mL fentanyl solution is administered from epidural catheter

Group 10

10 mL epidural initiation volume (bupivacaine + fentanyl)

Group Type ACTIVE_COMPARATOR

10 mL epidural initiation volume (bupivacaine + fentanyl)

Intervention Type DRUG

10 mL 0.625% bupivacaine + 2 μg/mL fentanyl solution is administered from epidural catheter

Group 20

20 mL epidural initiation volume (bupivacaine + fentanyl)

Group Type ACTIVE_COMPARATOR

20 mL epidural initiation volume (bupivacaine + fentanyl)

Intervention Type DRUG

20 mL 0.625% bupivacaine + + 2 μg/mL fentanyl solution is administered from epidural catheter

Interventions

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5 mL epidural initiation volume (bupivacaine + fentanyl)

5 mL 0.625% bupivacaine + 2 μg/mL fentanyl solution is administered from epidural catheter

Intervention Type DRUG

10 mL epidural initiation volume (bupivacaine + fentanyl)

10 mL 0.625% bupivacaine + 2 μg/mL fentanyl solution is administered from epidural catheter

Intervention Type DRUG

20 mL epidural initiation volume (bupivacaine + fentanyl)

20 mL 0.625% bupivacaine + + 2 μg/mL fentanyl solution is administered from epidural catheter

Intervention Type DRUG

Other Intervention Names

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Bupivacaine(Marcaine 0.5%), Fentanyl(Talinat 0.5mg/10mL) Bupivacaine(Marcaine 0.5%), Fentanyl(Talinat 0.5mg/10mL) Bupivacaine(Marcaine 0.5%), Fentanyl(Talinat 0.5mg/10mL)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Inonu University

OTHER

Sponsor Role lead

Responsible Party

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Osman Kacmaz

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahmut Durmus, Prof

Role: STUDY_CHAIR

Prof Dr

Locations

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Inonu University Turgut Ozal Medical Center

Malatya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 25425774 (View on PubMed)

Other Identifiers

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Inonu Anesthesia

Identifier Type: -

Identifier Source: org_study_id

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