NCT02025374

Brief Summary

Aim of the Study To compare the effects of hyperbaric bupivacaine plus fentanyl with hyperbaric levobupivacaine plus fentanyl on spinal block quality, haemodynamics and need for analgesics in patients undergoing elective cesarean section. Our hypothesis is that hyperbaric levobupivacaine will provide equal block quality, but better haemodynamic conditions compared to hyperbaric bupivacaine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2013

Typical duration for phase_4

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

August 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 1, 2014

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

May 16, 2019

Status Verified

May 1, 2019

Enrollment Period

Same day

First QC Date

December 12, 2013

Last Update Submit

May 15, 2019

Conditions

Health CareDrugs

Keywords

spinal anesthesiacesarean sectionhyperbaric levobupivacaine

Outcome Measures

Primary Outcomes (1)

  • evaluation of the changes in mean arterial blood pressure between two groups.

    6 month

Secondary Outcomes (1)

  • Time to reach T4 dermatome

    6 months

Study Arms (2)

Hyperbaric levobupivacaine

EXPERIMENTAL

Group 2 Hyperbaric levobupivacaine % 0.5 plus fentanyl; 2 ml total intrathecally

Drug: Hyperbaric levobupivacaine

Hyperbaric bupivacaine

ACTIVE COMPARATOR

Group 1 Hyperbaric bupivacaine % 0.5 plus fentanyl 2 ml intrathecally

Drug: Hyperbaric bupivacaine % 0.5

Interventions

Hyperbaric levobupivacaineDRUG
Also known as: Chirocaine %0.75
Hyperbaric levobupivacaine
Hyperbaric bupivacaine % 0.5DRUG
Also known as: Marcaine heavy % 0.5
Hyperbaric bupivacaine

Eligibility Criteria

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

You may qualify if:

  • elective cesarean section no other coexisting medical situation

You may not qualify if:

  • known contraindication to regional anesthesia coexisting pregnancy induced problem placental mislocation known allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balıkesir University Faculty of Medicine

Balıkesir, 10145, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
phase 4
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
Assistant Professor

Study Record Dates

First Submitted

December 12, 2013

First Posted

January 1, 2014

Study Start

August 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2016

Last Updated

May 16, 2019

Record last verified: 2019-05

Locations

TU(1)