NCT02680353

Brief Summary

To determine the postoperative analgesic efficiency of bilateral superficial plexus block, patients are divided into two groups. Study group received bilateral superficial plexus block, where control had none. Visual analog scale, opioid consumption and presence of nausea-vomiting are recorded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 11, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 19, 2017

Status Verified

April 1, 2017

Enrollment Period

1 year

First QC Date

February 9, 2016

Last Update Submit

April 18, 2017

Conditions

Block

Outcome Measures

Primary Outcomes (1)

  • Visual analog scale

    one time in postoperative period for one year

Secondary Outcomes (6)

  • Presence of nausea-vomiting

    In postoperative period for one year

  • Mean arterial pressure

    In both intraoperative and postoperative period for one year

  • Heart rate

    In both intraoperative and postoperative period for one year

  • Antiemetic usage

    postoperative period for one year

  • respiratory rate

    postoperative period for one year

  • +1 more secondary outcomes

Study Arms (2)

Study group

ACTIVE COMPARATOR

Patients received bilateral superficial cervical plexus block before operation

Procedure: Bilateral superficial cervical plexus block

Control group

NO INTERVENTION

Patients received no intervention before operation

Interventions

Bilateral superficial cervical plexus blockPROCEDURE

A kind of anesthetic nerve block type performed to block the nerve function temporarily by administrating local anesthetics through the trajectory of the nerve.

Study group

Eligibility Criteria

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

You may qualify if:

  • Over 18 years of age
  • Planned to undergo thyroidectomy
  • An American Society of Anesthesiologists score of 1 or 2

You may not qualify if:

  • Severe cardiovascular disease
  • Psychiatric diseases
  • Difficult intubation
  • Rejected to participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa University

Tokat Province, 60200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Hakan Tapar, Assist.Prof

    Gaziosmanpasa University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist.Prof.

Study Record Dates

First Submitted

February 9, 2016

First Posted

February 11, 2016

Study Start

April 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 19, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)