Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy

Study Overview
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Brief Summary
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With thyroid surgery being performed as an ambulatory procedure, most recent studies concerning post thyroidectomy analgesia are focused on regional techniques such as bilateral superficial cervical plexus block (BSCPB) and bilateral combined superficial and deep cervical plexus block. But, data regarding the efficacy of BSCPB are controversial. Hence the investigators compared the efficacy of BSCPB with 0.25% bupivacaine with or without clonidine in thyroidectomy, as preemptive analgesia. The hypothesis was bupivacaine with the addition of clonidine would help in reducing postoperative pain and thereby reduce the need for postoperative analgesia.

Detailed Description
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To find out if addition of BSCPB to general anesthesia with bupivacaine with or without clonidine prolongs the time needed for postoperative analgesic and facilitate to perform thyroidectomy as a day care procedure and to see if clonidine reduces postoperative nausea and vomiting.

Official Title
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Safety and Efficacy of Bilateral Superficial Cervical Plexus Block in Thyroidectomy - a Double Blind Randomized Controlled Trial

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: 0.9% Normal saline
* Drug: Bupivacaine
* Device: Bupivacaine with clonidine (combination)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consenting consecutive euthyroid patients undergoing elective thyroidectomy under general anesthesia, of either genders and more than 18 years of age, belonging to the ASA class I and II. Exclusion Criteria: Patients unable to understand visual analog pain score (VAS) or unable to use patient controlled analgesia (PCA). Patients with malignancy requiring block dissection or with substernal goiters - Contraindications to superficial cervical plexus block like allergy to local anesthetics, bleeding diatheses and local infection or sepsis. Contraindications to morphine like bronchial asthma and hypothyroidism. Sensitivity to the anesthetic agent used or intolerance to the medications used in the study. Patients who received steroids or opioids or other analgesics recently. Patients with history of stridor.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Saline<br>0.9% normal saline | Drug: 0.9% Normal saline<br>* Saline<br>* Other names: Saline;|
| Experimental: Bupivacaine<br>0.25% bupivacaine | Drug: Bupivacaine<br>* Bupivacaine - amide local anesthetic, maximum recommended dose is 2 mg/kg duration 2 - 4 hours of sensory anesthesia up to 24 hours<br>* Other names: Sensoricaine;|
| Experimental: Bupivacaine with clonidine<br>0.25% bupivacaine with 1 microgram/kg of clonidine | Device: Bupivacaine with clonidine (combination)<br>* Bupivacaine - amide local anesthetic, maximum recommended dose is 2 mg/kg duration 2 - 4 hours of sensory anesthesia up to 24 hours Clonidine - 0.5 - 1 microgram/ kg<br>* Other names: Sensoricaine (for bupivacaine);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative fentanyl requirement and the total morphine requirements in the 24-hour postoperative period |  | Intraoperative to 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog pain scores at specific time intervals |  | 24 hours postoperative | 
| Postoperative nausea and vomiting (PONV)and anti emetic requirements |  | 24 hours postoperative | 
| Side effects of the block, morphine and clonidine |  | 24 hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical plexus block, thyroidectomy, postoperative analgesia