Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02580500
Other study ID # lutfiye01
Secondary ID
Status Recruiting
Phase N/A
First received October 14, 2015
Last updated January 1, 2016
Start date October 2015
Est. completion date January 2016

Study information

Verified date January 2016
Source Lütfiye Nuri Burat Government Hospital
Contact Turgut Donmez, Surgeon
Phone 905347400967
Email surgeont73@hotmail.com
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date January 2016
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Procedure:
epidural catheter
epidural anaesthesia application for spinal catheter will be used
spinal catheter
spinal anesthesia application for spinal catheter will be used

Locations

Country Name City State
Turkey Lutfiye NBGH Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Lütfiye Nuri Burat Government Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Muslu B, Usta B, Muslu S, Yesilay A, Gözdemir 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. — View Citation

Orhon ZN, Koltka EN, Devrim S, Tüfekçi S, Dogru S, Çelik 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary sensory block duration(time:hour) group1 and group 2 up to 6 hours No
Secondary Duration of operation(time:hour) group1 and group 2 up to 2 hours No
Secondary Headache group 1 and group 2(participants) from end of the operation to postoperative 3 days No
Secondary Nausea/Vomiting group 1 and group 2(participants) from end of the operation to postoperative 1 day No
Secondary Urinary Retention group 1 and group 2 (participants) from end of the operation to postoperative 1 day No
See also
  Status Clinical Trial Phase
Completed NCT01662765 - Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease N/A