Superficial, Cervical Block in Thyroid Surgery, a Randomized Controlled Trial

Study Overview
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Brief Summary
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The study investigates the impact on post-operative pain of the superficial cervical block with bupivacaine combined with subcutaneous infiltration of the incisional area in thyroid surgery under general anesthesia. In addition, cost savings using the cervical block are evaluated (due to reduced length of hospital stay). The study is prospective, randomized, double blind, and placebo-controlled. The study is performed at the Department of Surgery, Cantonal Hospital of St. Gallen.

Official Title
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Impact and Cost Efficiency of Bilateral, Superficial Cervical Block in Thyroid Surgery Under General Anesthesia

Conditions
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Thyroidectomy

Intervention / Treatment
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* Drug: bilateral superficial cervical block
* Drug: placebo bilateral superficial cervical block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective thyroid or combined thyroid/parathyroid surgery, restricted to the central cervical compartment Informed consent Exclusion Criteria: Intolerance to used medication Recurrent disease Neck dissection, sternotomy Emergency surgery

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cervical block before surgery<br>bilateral superficial cervical block, placed before surgery (just before skin incision) | Drug: bilateral superficial cervical block<br>* 10 ml of 5% bupivacaine (Carbostesin®) was used for each side. Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side.<br>|
| Placebo Comparator: placebo cervical block before surgery<br>placebo bilateral superficial cervical block with saline, placed before surgery (just before skin incision) | Drug: placebo bilateral superficial cervical block<br>* 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side. Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side.<br>|
| Experimental: cervical block after surgery<br>bilateral superficial cervical block, placed after surgery (just after skin closure) | Drug: bilateral superficial cervical block<br>* 10 ml of 5% bupivacaine (Carbostesin®) was used for each side. Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side.<br>|
| Placebo Comparator: placebo cervical block after surgery<br>placebo bilateral superficial cervical block with saline, placed after surgery (just after skin closure) | Drug: placebo bilateral superficial cervical block<br>* 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side. Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Pain Measured by Visual Analogue Scale | Patient administered Instrument to indicate pain on a level from 0 to 10. (0: no pain, 10: worst imaginable pain) | 6 hours after surgery | 
| Pooled Relative Treatment Effect of VAS | Pain was obtained using the visual analog scale (VAS) three times daily for the 4 postoperative days (0 = no pain, 10 = worst imaginable pain) The pooled relative treatment effect is the probability of values being higher in one group than in another group (ranging from 0 to 1) | 4 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Pain Measured by Visual Analogue Scale | Patient administered Instrument to indicate pain on a level from 0 to 10. (0: no pain, 10: worst imaginable pain) | 24 hours after surgery | 
| Consumption of Post-operative Analgetics | number of participants taking post-operative analgetics | 5 days after surgery | 
| Mean Consumption of Post-operative Analgetics | mean pooled dose of post-operative analgetics | 5 days after surgery | 
| Hospital Stay | time from surgery to Hospital release in days | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Thyroid gland, cervical block, Pain, Postoperative