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Epidural and Spinal Anesthesia Techniques in Pilonidal Dermoid Sinus Surgeries

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2016 by TURGUT DONMEZ, Lütfiye Nuri Burat Government Hospital
Sponsor:
Information provided by (Responsible Party):
TURGUT DONMEZ, Lütfiye Nuri Burat Government Hospital
ClinicalTrials.gov Identifier:
NCT02580500
First received: October 14, 2015
Last updated: January 1, 2016
Last verified: January 2016
  Purpose

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 Intervention
Sinus; Dermal, Pilonidal Procedure: epidural catheter Procedure: spinal catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Epidural and Spinal Anesthesia Techniques in Pilonidal Dermoid Sinus Surgeries: Prospective Randomized Trials

Resource links provided by NLM:


Further study details as provided by TURGUT DONMEZ, Lütfiye Nuri Burat Government Hospital:

Primary Outcome Measures:
  • sensory block duration(time:hour) [ Time Frame: up to 6 hours ]
    group1 and group 2


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 100
Study Start Date: October 2015
Estimated Study Completion Date: January 2016
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02580500

Contacts
Contact: Turgut Donmez, Surgeon 905347400967 surgeont73@hotmail.com
Contact: Vuslat Muslu Erdem, anesthetist 905326354139 vuslatmuslu@gmail.com

Locations
Turkey
Lutfiye NBGH Recruiting
İstanbul, Turkey, 34300
Contact: Turgut Donmez, MD    00905347400967    surgeont73@hotmail.com   
Sponsors and Collaborators
Lütfiye Nuri Burat Government Hospital
Investigators
Principal Investigator: Turgut Donmez, Surgeon Lutfiye Nuri Burat Goverment Hospital
  More Information

Publications:
Responsible Party: TURGUT DONMEZ, General Surgeon, MD, Lütfiye Nuri Burat Government Hospital
ClinicalTrials.gov Identifier: NCT02580500     History of Changes
Other Study ID Numbers: lutfiye01
Study First Received: October 14, 2015
Last Updated: January 1, 2016

Keywords provided by TURGUT DONMEZ, Lütfiye Nuri Burat Government Hospital:
Epidural anesthesia
Spinal anesthesia
pilonidal dermoid sinus

Additional relevant MeSH terms:
Dermoid Cyst
Cysts
Neoplasms
Teratoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 19, 2017