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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

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.


Condition or disease Intervention/treatment Phase
Pilonidal Sinus Drug: Clonidine 75 µg/mL in sacrococcygeal block Drug: Clonidine 150 µg/mL in sacrococcygeal block Drug: Lidocaine Procedure: Pilonidal sinus Not Applicable

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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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sacrococcygeal Local Anesthesia With Different Doses of Clonidine for Pilonidal Sinus Surgery: A Prospective Randomized Trial
Study Start Date : October 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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).
Drug: Clonidine 75 µg/mL in sacrococcygeal block
Sacrococcygeal block will be performed using 75 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

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).
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




Primary Outcome Measures :
  1. Compare analgesic consumption using questionnaire [ Time Frame: Patients will be followed-up after the operation, an expected average of five days ]

Secondary Outcome Measures :
  1. 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 ]
  2. Pain using verbal numeric rating scale (VNRS) [ Time Frame: Patients will be followed-up after the operation, an expected average of five days ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for pilonidal sinus surgery

Exclusion Criteria:

  • Patients who have allergic reactions to lidocaine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02539693


Contacts
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Contact: Zoher Naja, MD +9611636000 ext 6405 zouhnaja@yahoo.com

Locations
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Lebanon
Makassed General Hospital Recruiting
Beirut, Lebanon
Contact: Zoher Naja, MD    +9611636000 ext 6405    zouhnaja@yahoo.com   
Sponsors and Collaborators
Makassed General Hospital
Investigators
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Principal Investigator: Zoher Naja, MD Makassed General Hospital

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Responsible Party: Zoher Naja, Chairperson of Anesthesia and Pain Management Department, Makassed General Hospital
ClinicalTrials.gov Identifier: NCT02539693     History of Changes
Other Study ID Numbers: 082015
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Clonidine
Pilonidal Sinus
Cysts
Neoplasms
Lidocaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents