Epidural and Spinal Anesthesia Techniques in Pilonidal Dermoid Sinus Surgeries

January 1, 2016 updated by: TURGUT DONMEZ, Lütfiye Nuri Burat Government Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • İstanbul, Turkey, 34300
        • Recruiting
        • Lutfiye NBGH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lütfiye Nuri Burat Government Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ACTUAL)

November 1, 2015

Study Completion (ANTICIPATED)

January 1, 2016

Study Registration Dates

First Submitted

October 14, 2015

First Submitted That Met QC Criteria

October 16, 2015

First Posted (ESTIMATE)

October 20, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

January 5, 2016

Last Update Submitted That Met QC Criteria

January 1, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • lutfiye01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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