Clinical Trial: Sacrococcygeal Local Anesthesia With Different Doses of Clonidine for Pilonidal Sinus Surgery
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 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 Summary:
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 The needle is partially withdrawn and reinserted at 45 degrees to the skin aiming towards the center of the pilonidal sinus and an injection will be performed.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 th
Sponsor: Makassed General Hospital
Current Primary Outcome: Compare analgesic consumption using questionnaire [ Time Frame: Patients will be followed-up after the operation, an expected average of five days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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: Same as current
Information By: Makassed General Hospital
Dates:
Date Received: September 1, 2015
Date Started: October 2016
Date Completion: November 2017
Last Updated: January 7, 2017
Last Verified: January 2017
