NCT02544893

Brief Summary

we aimed postoperative analgesic effects of using bupivacaine alone or added dexmedetomidine for ultrasound guided thoracic paravertebral block in thoracotomy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for phase_4 pain

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_4 pain

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

September 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 3, 2016

Status Verified

August 1, 2016

Enrollment Period

6 months

First QC Date

September 7, 2015

Last Update Submit

August 2, 2016

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • opioid consumption

    patient controlled analgesia

    postoperative 24 hours

Secondary Outcomes (1)

  • visual analog scale

    postoperative 1 day

Study Arms (3)

bupivacaine

ACTIVE COMPARATOR

0,5% 20 ml bupivacaine added 0.9% 1 ml serum physiologic on paravertebral block

Drug: bupivacaine

dexmedetomidine

ACTIVE COMPARATOR

100 mcg dexmedetomidine added to 0,5% 20 ml bupivacaine on paravertebral block

Drug: dexmedetomidin

serum phsyologic

ACTIVE COMPARATOR

0,9% 21 ml serum physiologic

Drug: serum physiologic

Interventions

bupivacaineDRUG

21 ml 0.5 %bupivacaine is applied paravertebral space

Also known as: marcaine
bupivacaine
dexmedetomidinDRUG

1 ml dexmedetomidin + 20 ml 0.5 % bupivacaine are applied paravertebral space

Also known as: precedex
dexmedetomidine
serum physiologicDRUG

21 ml serum physiologic is applied paravertebral space

serum phsyologic

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1-2
  • aged
  • patient undergoing thoracotomy

You may not qualify if:

  • chronic opioid consumption
  • bupivacaine and dexmedetomidine allergies
  • coagulopathy
  • infection at the needle insertion side
  • chronic liver and kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University Medicine Faculty

Kayseri, 38080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

BupivacaineDexmedetomidine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • esra n ünalan, resident

    TC Erciyes University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

September 7, 2015

First Posted

September 9, 2015

Study Start

September 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

August 3, 2016

Record last verified: 2016-08

Locations

TU(1)