Epidural and Spinal Anesthesia Techniques in Pilonidal De... | NCT02580500

Studies
Epidural and Spinal Anesthesia Techniques in Pilonidal Dermoid Sinus Surgeries

NCT02580500

Sponsor

Lütfiye Nuri Burat Government Hospital

Status

Unknown status

Last Update Posted

Jan 5, 2016Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Sinus; Dermal, Pilonidal

Interventions

epidural catheter
spinal catheter

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Nov 2015Actual

Completion Date

Jan 2016Estimated

First Submitted Date

Oct 14, 2015

First Submission Date that Met QC Criteria

Oct 16, 2015

First Posted Date

Oct 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 1, 2016

Last Update Posted Date

Jan 5, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

TURGUT DONMEZ, General Surgeon, MD, Lütfiye Nuri Burat Government HospitalPrincipal Investigator

Lead Sponsor

Lütfiye Nuri Burat Government HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Pilonidal dermoid cyst surgery under general anesthesia and regional anesthesia techniques is used.regional anesthesia techniques; spinal, epidural, spinal epidural (combined) and is the local anesthesia.In the investigators study, pilonidal dermoid cyst surgery in spinal and epidural anesthesia techniques activity, reliability will be compared to the side effects and complications.

One hundred patients will be randomly assigned to either the pilonidal dermoid cyst under Spinal anaesthesia (50 patients)(Group 1) or pilonidal dermoid cyst under epidural anaesthesia (50 patients)(Group 2). Group 1 will be used in spinal catheter in spinal anesthesia procedures or Group 2 will be used epidural catheter in epidural anaesthesia procedures.All patients has symptomatic pilonidal dermoid cyst.

Detailed Description

Pilonidal dermoid is a tubular skin defect which can be seen in both female and male patients between the ages of 12 to 80. Treatment alternatives includes surgical excision. During the surgical treatment local, general, spinal or epidural anesthesia could be applied. However, local anesthesia usually is not preferred due to the fact that pilonidal dermoid sinuses depth, width could not be determined precisely. General anesthesia also is not preferred due to the fact that difficulties arising from patient's positioning and positioning based potential lung related problems. In general, spinal anesthesia and epidural anesthesia is preferred for pilonidal dermoid sinus surgeries. In this study, the investigators will demonstrate advantages, disadvantages, complications, (sensory and motor block levels), and durations of spinal and epidural anesthesia and superiority of each on these subjects.

Patients who are over 18 and have a America Society of Anesthesiologist (ASA) physical score of I and II will be included in the study. Patients who are pregnant, have a known allergic reactions to local anesthetic and have contraindications against spinal and epidural anesthetic will be excluded from the study.

In this study the investigators separate the patients into 2 groups. Group1: pilonidal dermoid cyst under Spinal anaesthesia (50 patients).Group 1 will be used in spinal catheter in spinal anesthesia procedures ; Group2:pilonidal dermoid cyst under epidural anaesthesia (50 patient).Group 2 will be used epidural catheter in epidural anaesthesia procedures. All patients has symptomatic pilonidal dermoid cyst

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group 1	Active Comparator	Pilonidal dermoid cyst surgery in Spinal anaesthesia	Procedure: spinal catheter
group 2	Active Comparator	Pilonidal dermoid cyst surgery in Epidural anaesthesia	Procedure: epidural catheter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
epidural catheter	Procedure	epidural anaesthesia application for spinal catheter will be used	group 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sensory block duration(time:hour)	group1 and group 2	up to 6 hours

Secondary Outcomes

Measure	Description	Time Frame
Duration of operation(time:hour)	group1 and group 2	up to 2 hours
Headache	group 1 and group 2(participants)	from end of the operation to postoperative 3 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

America Society of Anesthesiologist (ASA) physical score of I and II
the men and women over the age of 18, pilonidal sinus disease

Exclusion Criteria:

Pediatric patients
Pregnant women
Patients with bleeding disorder
Patients with spinal deformity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Turgut Donmez, Surgeon	Contact	905347400967		surgeont73@hotmail.com
Vuslat Muslu Erdem, anesthetist	Contact	905326354139		vuslatmuslu@gmail.com

Overall Officials

Name	Affiliation	Role
Turgut Donmez, Surgeon	Lutfiye Nuri Burat Goverment Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lutfiye NBGH	Recruiting	Istanbul		34300	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19461565	Background	Muslu B, Usta B, Muslu S, Yesilay A, Gozdemir M, Sert H, Demircioglu R. Effect of locally administered lornoxicam in the management of low back pain after lumbar epidural anesthesia: a double-blind, randomized, controlled study. Minerva Anestesiol. 2009 Sep;75(9):494-7. Epub 2009 May 21.
25844132	Background

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms