Epidural and Spinal Anesthesia Techniques in Pilonidal Dermoid Sinus Surgeries
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|ClinicalTrials.gov Identifier: NCT02580500|
Recruitment Status : Unknown
Verified January 2016 by TURGUT DONMEZ, Lütfiye Nuri Burat Government Hospital.
Recruitment status was: Recruiting
First Posted : October 20, 2015
Last Update Posted : January 5, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Sinus; Dermal, Pilonidal||Procedure: epidural catheter Procedure: spinal catheter||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Epidural and Spinal Anesthesia Techniques in Pilonidal Dermoid Sinus Surgeries: Prospective Randomized Trials|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||November 2015|
|Estimated Study Completion Date :||January 2016|
Active Comparator: group 1
Pilonidal dermoid cyst surgery in Spinal anaesthesia
Procedure: spinal catheter
spinal anesthesia application for spinal catheter will be used
Active Comparator: group 2
Pilonidal dermoid cyst surgery in Epidural anaesthesia
Procedure: epidural catheter
epidural anaesthesia application for spinal catheter will be used
- sensory block duration(time:hour) [ Time Frame: up to 6 hours ]group1 and group 2
- Duration of operation(time:hour) [ Time Frame: up to 2 hours ]group1 and group 2
- Headache [ Time Frame: from end of the operation to postoperative 3 days ]group 1 and group 2(participants)
- Nausea/Vomiting [ Time Frame: from end of the operation to postoperative 1 day ]group 1 and group 2(participants)
- Urinary Retention [ Time Frame: from end of the operation to postoperative 1 day ]group 1 and group 2 (participants)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02580500
|Contact: Turgut Donmez, Surgeonemail@example.com|
|Contact: Vuslat Muslu Erdem, firstname.lastname@example.org|
|İstanbul, Turkey, 34300|
|Contact: Turgut Donmez, MD 00905347400967 email@example.com|
|Principal Investigator:||Turgut Donmez, Surgeon||Lutfiye Nuri Burat Goverment Hospital|