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Trial record 65 of 328 for:    clonidine

Sacrococcygeal Local Anesthesia With Different Doses of Clonidine for Pilonidal Sinus Surgery

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ClinicalTrials.gov Identifier: NCT02539693
Recruitment Status : Recruiting
First Posted : September 3, 2015
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Zoher Naja, Makassed General Hospital

Tracking Information
First Submitted Date  ICMJE September 1, 2015
First Posted Date  ICMJE September 3, 2015
Last Update Posted Date September 27, 2019
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2015)
Compare analgesic consumption using questionnaire [ Time Frame: Patients will be followed-up after the operation, an expected average of five days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02539693 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2015)
  • 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 ]
  • Pain using verbal numeric rating scale (VNRS) [ Time Frame: Patients will be followed-up after the operation, an expected average of five days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sacrococcygeal Local Anesthesia With Different Doses of Clonidine for Pilonidal Sinus Surgery
Official Title  ICMJE Sacrococcygeal Local Anesthesia With Different Doses of Clonidine for Pilonidal Sinus Surgery: A Prospective Randomized Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pilonidal Sinus
Intervention  ICMJE
  • Drug: Clonidine 75 µg/mL in sacrococcygeal block
    Sacrococcygeal block will be performed using 75 µg/mL clonidine in the anesthetic mixture
  • Drug: Clonidine 150 µg/mL in sacrococcygeal block
    Sacrococcygeal block will be performed using 150 µg/mL clonidine in the anesthetic mixture
  • Drug: Lidocaine
    3 ml lidocaine 1% is injected at each block site
  • Procedure: Pilonidal sinus
    Removal of pilonidal sinus
Study Arms  ICMJE
  • 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).
    Interventions:
    • Drug: Clonidine 75 µg/mL in sacrococcygeal block
    • Drug: Lidocaine
    • Procedure: 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).
    Interventions:
    • Drug: Clonidine 150 µg/mL in sacrococcygeal block
    • Drug: Lidocaine
    • Procedure: Pilonidal sinus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 2, 2015)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients scheduled for pilonidal sinus surgery

Exclusion Criteria:

  • Patients who have allergic reactions to lidocaine
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zoher Naja, MD +9611636000 ext 6405 zouhnaja@yahoo.com
Listed Location Countries  ICMJE Lebanon
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02539693
Other Study ID Numbers  ICMJE 082015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zoher Naja, Makassed General Hospital
Study Sponsor  ICMJE Makassed General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zoher Naja, MD Makassed General Hospital
PRS Account Makassed General Hospital
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP