Sinus; Dermal, PilonidalNCT02580500
Epidural and Spinal Anesthesia Techniques in Pilonidal Dermoid Sinus Surgeries
A study testing epidural catheter and spinal catheter in people with Sinus; Dermal, Pilonidal, run by Lütfiye Nuri Burat Government Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sinus; Dermal, Pilonidal
- What is being tested?
- epidural catheter and spinal catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- America Society of Anesthesiologist (ASA) physical score of I and II
- the men and women over the age of 18, pilonidal sinus disease
Who cannot join
- Pediatric patients
- Pregnant women
- Patients with bleeding disorder
- Patients with spinal deformity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Lutfiye NBGH
Istanbul, 34300
Turgut Donmez, MD, 00905347400967, surgeont73@hotmail.com
About this study
Official title: 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.
Read the 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
- Conditions
- Sinus; Dermal, Pilonidal
- Being tested
- epidural catheter, spinal catheter
- Keywords
- Epidural anesthesia, Spinal anesthesia, pilonidal dermoid sinus
- Medical subject headings
- Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural catheterProcedure or surgery
epidural anaesthesia application for spinal catheter will be used
spinal catheterProcedure or surgery
spinal anesthesia application for spinal catheter will be used
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | Pilonidal dermoid cyst surgery in Spinal anaesthesia Receives: Procedure: spinal catheter |
| group 2 | Active comparator | Pilonidal dermoid cyst surgery in Epidural anaesthesia Receives: Procedure: epidural catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensory block duration(time:hour)
group1 and group 2
Measured: up to 6 hours
Secondary outcomes (4)
Duration of operation(time:hour)
group1 and group 2
Measured: up to 2 hours
Headache
group 1 and group 2(participants)
Measured: from end of the operation to postoperative 3 days
Nausea/Vomiting
group 1 and group 2(participants)
Measured: from end of the operation to postoperative 1 day
Urinary Retention
group 1 and group 2 (participants)
Measured: from end of the operation to postoperative 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionNov 2015
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sinus; Dermal, PilonidalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lütfiye Nuri Burat Government Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, TURGUT DONMEZ, Lütfiye Nuri Burat Government Hospital
- Investigators
- Turgut Donmez, Surgeon, Principal investigator, Lutfiye Nuri Burat Goverment Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580500
- Sponsor's protocol ID
- lutfiye01
- Status last verified
- Jan 2016
- First submitted
- 14 Oct 2015
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Muslu B, Usta B, Muslu S, Yesilay A, Gozdemir 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.
PubMed 19461565Orhon ZN, Koltka EN, Devrim S, Tufekci S, Dogru S, Celik 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.
PubMed 25844132
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural and Spinal Anesthesia Techniques in Pilonidal Dermoid Sinus Surgeries: Prospective Randomized Trials
- ClinicalTrials.gov ID
- NCT02580500
- Acronym / sponsor ID
- lutfiye01
- Conditions
- Sinus; Dermal, Pilonidal
- Keywords
- Epidural anesthesia, Spinal anesthesia, pilonidal dermoid sinus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lütfiye Nuri Burat Government HospitalOther government
- Study start
- Oct 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (estimated)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Procedure: spinal catheterPilonidal dermoid cyst surgery in Spinal anaesthesia |
| group 2 | Active comparator | Procedure: epidural catheterPilonidal dermoid cyst surgery in Epidural anaesthesia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- America Society of Anesthesiologist (ASA) physical score of I and II
- the men and women over the age of 18, pilonidal sinus disease
Key exclusion criteria (4 listed)
- Pediatric patients
- Pregnant women
- Patients with bleeding disorder
- Patients with spinal deformity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epidural catheterepidural anaesthesia application for spinal catheter will be used | Procedure or surgery | group 2 |
| spinal catheterspinal anesthesia application for spinal catheter will be used | Procedure or surgery | group 1 |
Primary outcome
sensory block duration(time:hour)
Time frame: up to 6 hours
group1 and group 2
4 secondary outcomes
Duration of operation(time:hour)
Time frame: up to 2 hours
Headache
Time frame: from end of the operation to postoperative 3 days
Nausea/Vomiting
Time frame: from end of the operation to postoperative 1 day
Urinary Retention
Time frame: from end of the operation to postoperative 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
- Background: PubMed 19461565Muslu B, Usta B, Muslu S, Yesilay A, Gozdemir 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.
- Background: PubMed 25844132Orhon ZN, Koltka EN, Devrim S, Tufekci S, Dogru S, Celik 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Turgut Donmez, Surgeon principal investigator
Lutfiye Nuri Burat Goverment Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing epidural catheter and spinal catheter in people with Sinus; Dermal, Pilonidal, run by Lütfiye Nuri Burat Government Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Turgut Donmez, Surgeon (905347400967, surgeont73@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensory block duration(time:hour) (time frame: up to 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02580500, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2016.