Epidural and Spinal Anesthesia Techniques in Pilonidal Dermoid Sinus Surgeries

NCT ID: NCT02580500

Last Updated: 2016-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-01-31

Brief Summary

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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

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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

Conditions

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Sinus; Dermal, Pilonidal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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group 1

Pilonidal dermoid cyst surgery in Spinal anaesthesia

Group Type ACTIVE_COMPARATOR

spinal catheter

Intervention Type PROCEDURE

spinal anesthesia application for spinal catheter will be used

group 2

Pilonidal dermoid cyst surgery in Epidural anaesthesia

Group Type ACTIVE_COMPARATOR

epidural catheter

Intervention Type PROCEDURE

epidural anaesthesia application for spinal catheter will be used

Interventions

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epidural catheter

epidural anaesthesia application for spinal catheter will be used

Intervention Type PROCEDURE

spinal catheter

spinal anesthesia application for spinal catheter will be used

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lütfiye Nuri Burat Government Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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TURGUT DONMEZ

General Surgeon, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Turgut Donmez, Surgeon

Role: PRINCIPAL_INVESTIGATOR

Lutfiye Nuri Burat Goverment Hospital

Locations

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Lutfiye NBGH

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Turgut Donmez, Surgeon

Role: CONTACT

905347400967

Vuslat Muslu Erdem, anesthetist

Role: CONTACT

905326354139

Facility Contacts

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Turgut Donmez, MD

Role: primary

00905347400967

References

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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.

Reference Type BACKGROUND
PMID: 19461565 (View on PubMed)

Orhon ZN, Koltka EN, Devrim S, Tufekci S, Dogru S, Celik M. Epidural anesthesia for pilonidal sinus surgery: ropivacaine versus levobupivacaine. Korean J Anesthesiol. 2015 Apr;68(2):141-7. doi: 10.4097/kjae.2015.68.2.141. Epub 2015 Mar 30.

Reference Type BACKGROUND
PMID: 25844132 (View on PubMed)

Other Identifiers

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lutfiye01

Identifier Type: -

Identifier Source: org_study_id

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