Epidural and Spinal Anesthesia Techniques in Pilonidal Dermoid Sinus Surgeries

Sinus; Dermal, Pilonidal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02580500
• Other study ID #: lutfiye01
• 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

• Dermoid Cyst
• Sinus; Dermal, Pilonidal

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