Bilateral Superficial Cervical Block for Thyroidectomy

Study Overview
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Brief Summary
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The objective of this study is to compare the postoperative analgesia afforded by bilateral superficial cervical block using different concentrations of local anesthetic (ropivacaine) in patients undergoing total thyroidectomy for the mini-incision technique, performed by the same surgical team.

Detailed Description
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In this study we will evaluate the efficacy of bilateral superficial cervical block associated with balanced general anesthesia with remifentanil as opioid of choice in preventing postoperative pain in patients who underwent total thyroidectomy with mini incision without neck dissection.A hundred and twenty patients ASA I - II will be assessed and allocated randomly (through a table of random numbers) into three groups for analgesia for post-operative: Group 1: bilateral superficial cervical block with 20 ml of 0.9% saline (placebo); Group 2: bilateral superficial cervical block with 20 ml ropivacaine 0.25%; Group 3: bilateral superficial cervical block with 20 ml ropivacaine 0.5%.

Official Title
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Evaluation of the Postoperative Analgesic Efficacy of Bilateral Superficial Cervical Block for Thyroidectomy and Mini Incision Under General Balanced Anesthesia: a Randomized, Triple Masked, Placebo Controlled Trial.

Conditions
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Cervical Pain

Intervention / Treatment
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* Drug: 0.9% saline
* Drug: Ropivacaine
* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than 18 years Agreed to participate in the study and sign the consent form ASA I-II Scheduled to undergo total thyroidectomy without neck dissection under general balanced anesthesia. Exclusion Criteria: Clinical history or laboratory tests suggestive of bleeding disorder Mental or cognitive deficit in existence, which makes it impossible to understand the patient visual analog scale of pain or the study protocol Body mass index greater than 45 History of allergy to local anesthetics Intolerance or contraindication to any medication used in the study Skin infection at the site of the blockade Patients requiring neck dissection Pregnancy Preoperative use of opioid analgesics or non-opioids, corticosteroids or anti inflammatory non steroidal Patient's refusal to participate in the study Need for emergency reintervention within the first 24 hours postoperatively

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Bilateral superficial cervical block. | Drug: 0.9% saline<br>* 20 ml of 0.9% saline<br>|
| Experimental: Ropivacaine 0.25%<br>Bilateral superficial cervical block | Drug: Ropivacaine<br>* 20 ml of Ropivacaine 0.25%.<br>|
| Experimental: Ropivacaine 0.5%<br>Bilateral superficial cervical block. | Drug: Ropivacaine<br>* 20 ml of Ropivacaine 0.5%.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain assessment according to Visual Analogue Scale |  | 24 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumption of morphine |  | 24 Hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Superficial cervical block, Thyroidectomy, Pain