Sacrococcygeal Local Anesthesia With Different Doses of Clonidine for Pilonidal Sinus Surgery
Primary Purpose
Pilonidal Sinus
Status
Recruiting
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Clonidine 75 µg/mL in sacrococcygeal block
Clonidine 150 µg/mL in sacrococcygeal block
Lidocaine
Pilonidal sinus
Sponsored by
About this trial
This is an interventional treatment trial for Pilonidal Sinus
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for pilonidal sinus surgery
Exclusion Criteria:
- Patients who have allergic reactions to lidocaine
Sites / Locations
- Makassed General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Clonidine 75
Clonidine 150
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
Compare analgesic consumption using questionnaire
Secondary Outcome Measures
Time needed to return to normal activity noted by calling the patients
Pain using verbal numeric rating scale (VNRS)
Full Information
NCT ID
NCT02539693
First Posted
September 1, 2015
Last Updated
January 14, 2022
Sponsor
Makassed General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02539693
Brief Title
Sacrococcygeal Local Anesthesia With Different Doses of Clonidine for Pilonidal Sinus Surgery
Official Title
Sacrococcygeal Local Anesthesia With Different Doses of Clonidine for Pilonidal Sinus Surgery: A Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 2016 (undefined)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Makassed General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Sinus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Clonidine 75
Arm Type
Experimental
Arm Description
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).
Arm Title
Clonidine 150
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Clonidine 75 µg/mL in sacrococcygeal block
Intervention Description
Sacrococcygeal block will be performed using 75 µg/mL clonidine in the anesthetic mixture
Intervention Type
Drug
Intervention Name(s)
Clonidine 150 µg/mL in sacrococcygeal block
Intervention Description
Sacrococcygeal block will be performed using 150 µg/mL clonidine in the anesthetic mixture
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
3 ml lidocaine 1% is injected at each block site
Intervention Type
Procedure
Intervention Name(s)
Pilonidal sinus
Intervention Description
Removal of pilonidal sinus
Primary Outcome Measure Information:
Title
Compare analgesic consumption using questionnaire
Time Frame
Patients will be followed-up after the operation, an expected average of five days
Secondary Outcome Measure Information:
Title
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
Title
Pain using verbal numeric rating scale (VNRS)
Time Frame
Patients will be followed-up after the operation, an expected average of five days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled for pilonidal sinus surgery
Exclusion Criteria:
Patients who have allergic reactions to lidocaine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zoher Naja, MD
Phone
+9611636000
Ext
6405
Email
zouhnaja@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zoher Naja, MD
Organizational Affiliation
Makassed General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Makassed General Hospital
City
Beirut
Country
Lebanon
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zoher Naja, MD
Phone
+9611636000
Ext
6405
Email
zouhnaja@yahoo.com
12. IPD Sharing Statement
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Sacrococcygeal Local Anesthesia With Different Doses of Clonidine for Pilonidal Sinus Surgery
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