Epidural and Spinal Anesthesia Techniques in Pilonidal Dermoid Sinus Surgeries

Study Overview
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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

Official Title
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Epidural and Spinal Anesthesia Techniques in Pilonidal Dermoid Sinus Surgeries: Prospective Randomized Trials

Conditions
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Sinus; Dermal, Pilonidal

Intervention / Treatment
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* Procedure: epidural catheter
* Procedure: spinal catheter


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group 1<br>Pilonidal dermoid cyst surgery in Spinal anaesthesia | Procedure: spinal catheter<br>* spinal anesthesia application for spinal catheter will be used<br>|
| Active Comparator: group 2<br>Pilonidal dermoid cyst surgery in Epidural anaesthesia | Procedure: epidural catheter<br>* epidural anaesthesia application for spinal catheter will be used<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Nausea/Vomiting | group 1 and group 2(participants) | from end of the operation to postoperative 1 day | 
| Urinary Retention | group 1 and group 2 (participants) | from end of the operation to postoperative 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural anesthesia, Spinal anesthesia, pilonidal dermoid sinus