NCT03156322

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
Last Updated

May 18, 2017

Status Verified

May 1, 2017

Enrollment Period

11 months

First QC Date

May 9, 2017

Last Update Submit

May 16, 2017

Conditions

Pain, Postoperative

Keywords

cesarean sectioncombined spinal epidural anesthesiapatient controlled epidural analgesiapostoperative pain

Outcome Measures

Primary Outcomes (1)

  • Change in postoperative pain scores

    Visual analog scale

    up to 12 hours after cesarean delivery

Secondary Outcomes (3)

  • First analgesic demand time

    up to 12 hours after cesarean delivery

  • The number of analgesic requirement

    up to 12 hours after cesarean delivery

  • Morphine requirement

    up to 12 hours after cesarean delivery

Other Outcomes (1)

  • Side effects associated with epidural analgesia

    up to 12 hours after cesarean delivery

Study Arms (3)

Group 5

ACTIVE COMPARATOR

5 mL epidural initiation volume (bupivacaine + fentanyl)

Drug: 5 mL epidural initiation volume (bupivacaine + fentanyl)

Group 10

ACTIVE COMPARATOR

10 mL epidural initiation volume (bupivacaine + fentanyl)

Drug: 10 mL epidural initiation volume (bupivacaine + fentanyl)

Group 20

ACTIVE COMPARATOR

20 mL epidural initiation volume (bupivacaine + fentanyl)

Drug: 20 mL epidural initiation volume (bupivacaine + fentanyl)

Interventions

5 mL epidural initiation volume (bupivacaine + fentanyl)DRUG

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

Also known as: Bupivacaine(Marcaine 0.5%), Fentanyl(Talinat 0.5mg/10mL)
Group 5
10 mL epidural initiation volume (bupivacaine + fentanyl)DRUG

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

Also known as: Bupivacaine(Marcaine 0.5%), Fentanyl(Talinat 0.5mg/10mL)
Group 10
20 mL epidural initiation volume (bupivacaine + fentanyl)DRUG

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

Also known as: Bupivacaine(Marcaine 0.5%), Fentanyl(Talinat 0.5mg/10mL)
Group 20

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiology risks classification II
  • Term pregnant

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University Turgut Ozal Medical Center

Malatya, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 25425774RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

BupivacaineFentanyl

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Mahmut Durmus, Prof

    Prof Dr

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

May 9, 2017

First Posted

May 17, 2017

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

May 18, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)