Epidural and Spinal Anesthesia Techniques in Pilonidal Dermoid Sinus Surgeries: Prospective Randomized Trials
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- sensory block duration(time:hour)
Study Overview
Brief 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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
group 2
Pilonidal dermoid cyst surgery in Epidural anaesthesia
Intervention: epidural catheter (Procedure)
group 1
Pilonidal dermoid cyst surgery in Spinal anaesthesia
Intervention: spinal catheter (Procedure)
Outcomes
Primary Outcomes
sensory block duration(time:hour)
Time Frame: up to 6 hours
group1 and group 2
Secondary Outcomes
- Headache(from end of the operation to postoperative 3 days)
- Urinary Retention(from end of the operation to postoperative 1 day)
- Duration of operation(time:hour)(up to 2 hours)
- Nausea/Vomiting(from end of the operation to postoperative 1 day)
Investigators
TURGUT DONMEZ
General Surgeon, MD
Lütfiye Nuri Burat Government Hospital