- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02539693
Sacrococcygeal Local Anesthesia With Different Doses of Clonidine for Pilonidal Sinus Surgery
Sacrococcygeal Local Anesthesia With Different Doses of Clonidine for Pilonidal Sinus Surgery: A Prospective Randomized Trial
Sacrococcygeal local anesthesia was shown to reduce the time spent in the operating room as well as in the recovery room. In addition, decreased hospital stay and postoperative analgesic consumption.
Given the effectiveness of sacrococcygeal local anesthesia in pilonidal sinus surgery, it would be valuable to study the effect of the local anesthesia with 75µg/mL of clonidine versus 150µg/mL.
Study Overview
Status
Conditions
Detailed Description
Study design and sampling
This is a prospective study with a randomized double-blind design that will be conducted between October 2015 and October 2016.
Patients scheduled for pilonidal sinus surgery will be included. Patients will be randomly distributed to one of 2 groups with 30 patients in each, using the sealed envelope technique. Group one will receive sacrococcygeal local anesthesia with 75µg/mL of clonidine, while group two will receive sacrococcygeal local anesthesia with 150µg/mL of clonidine.
Anesthetic techniques
Being a double-blinded study, a specialized nurse will prepare the syringes for each patient.
Sacrococcygeal local anesthesia technique
The Sacrococcygeal block will be performed with the patient in the prone position. Four injection sites are marked on the skin after aseptic preparation.
The sites are placed as follows: 4 cm below and above the pilonidal sinus and 3 cm lateral to its center on both sides. Therefore a "lozenge" is formed by connecting the 4 sites.
At first, an injection of 0.3 ml lidocaine 1% is injected at each site using an 8-mm 30G needle. Then 4 injections are admitted to each of the 4 injection sites in turn, with equal supply of the anesthetic mixture in the following manner: a 10-mm 27G needle containing the anesthetic mixture is introduced perpendicularly to the skin and the mixture is infiltrated. The needle is partially withdrawn and reinserted at 45 degrees to the skin aiming towards the center of the pilonidal sinus and an injection will be performed. Then the needle is partially withdrawn again and reinserted at an angle of 45 degrees to the skin aiming at one side of the lozenge then at the other side where injections are done.
In case of a multiple pilonidal orifices, a hexagon is done. These sites are then anesthetized as previously described.
Anesthetic mixture
For group 1, the syringe will contain: lidocaine 2% 14 mL, bupivacaine 0.5% 5 mL, and clonidine 0.5 mL with 0.5 mL of saline (thus 75 µg/mL).
As for group 2, the syringes will contain: lidocaine 2% 14 mL, bupivacaine 0.5% 5 mL, and clonidine 1 mL (thus 150 µg/mL).
Depending on each patient's weight and type of pilonidal sinus, the anesthetic mixture might vary from 30 to 40 mL in total.
Data collection
Demographic data, type and duration of surgery will be recorded. Haemodynamics will be registered at all times (pre-operatively, intra-operatively and post-operatively).
Pain will be assessed using VNRS with 0 being no pain and 10 maximum pain for 48 hours post-operatively.
As for postoperative analgesia consumption, patients with a VNRS score less than 3 are given paracetamol 1000 mg each 8 hours. If VNRS is between three and four, patients are given Tramadol Hydrochloride 50-100 mg every 4- 6 hours and if the VNRS score is greater or equal to five, patients receive 1 mg/kg Dolosal.
Return to normal activity will be defined by the ability to sit, walk and work comfortably and will be assessed by calling the patients.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beirut, Lebanon
- Recruiting
- Makassed General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients scheduled for pilonidal sinus surgery
Exclusion Criteria:
- Patients who have allergic reactions to lidocaine
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Clonidine 75
Patients will receive sacrococcygeal local anesthesia with 75µg/mL of clonidine.
The anesthetic mixture will contain: lidocaine 2% 14 mL, bupivacaine 0.5% 5 mL, and clonidine 0.5 mL with 0.5 mL of saline (thus 75 µg/mL).
|
Sacrococcygeal block will be performed using 75 µg/mL clonidine in the anesthetic mixture
3 ml lidocaine 1% is injected at each block site
Removal of pilonidal sinus
|
Experimental: Clonidine 150
Patients will receive sacrococcygeal local anesthesia with 150µg/mL of clonidine.
The anesthetic mixture will contain: lidocaine 2% 14 mL, bupivacaine 0.5% 5 mL, and clonidine 1 mL (thus 150 µg/mL).
|
3 ml lidocaine 1% is injected at each block site
Removal of pilonidal sinus
Sacrococcygeal block will be performed using 150 µg/mL clonidine in the anesthetic mixture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Compare analgesic consumption using questionnaire
Time Frame: Patients will be followed-up after the operation, an expected average of five days
|
Patients will be followed-up after the operation, an expected average of five days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time needed to return to normal activity noted by calling the patients
Time Frame: Patients will be followed-up after the operation, an expected average of five days
|
Patients will be followed-up after the operation, an expected average of five days
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Pain using verbal numeric rating scale (VNRS)
Time Frame: Patients will be followed-up after the operation, an expected average of five days
|
Patients will be followed-up after the operation, an expected average of five days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Cysts
- Pilonidal Sinus
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Sympatholytics
- Lidocaine
- Clonidine
Other Study ID Numbers
- 082015
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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