Regional Anesthesia for Thyroidectomy

Study Overview
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Brief Summary
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For more than 25 years, Regional Anesthesia has challenged anesthesiologists to determine whether it offers real benefits in terms of patient outcome from major surgery, compared with general anesthesia. Although it is clear that regional analgesia in association with general anesthesia substantially reduces postoperative pain, the benefits in terms of overall perioperative outcome are controversial. The aim of this study is to evaluate the effect on short and long-term postoperative outcomes of adding regional analgesia to general anaesthesia in thoridetomic patients.

Detailed Description
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Patients who are divided into two treatment groups: (a) a bilateral superficial cervical plexus group (group S) and a control group (group C).We performe bilateral superficial cervical plexus block (BSCPB)with 0.25-0.75% ropivacaine10 ml to group S and 10ml NaCl 0.9% to group C. All BSCPB is performed by experienced anesthesia doctor after a standardized induction of general anaesthesia.eneral anaesthesia was induced by using intravenously with midazolam,propofol, fentanyl, cisatracurium is injected IV to facilitate orotracheal intubation. After a standardized induction of general anaesthesia, patients receive Regional Anesthesia at the discretion of the experienced anesthesiologist who was blinded to treatment. The patient is placed in a supine position with the head turned away from the side to be blocked, and then the sternocleidomastoid muscle (SCM) is identified by slight head elevation. SCPB is performed with a 26-gauge needle that is inserted at the midpoint of the posterior border of the SCM muscle and the needle is advanced just past the SCM muscle.

Official Title
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Randomized Controlled Trial of Regional Anesthesia in Combination With General Anesthesia for Thyroidectomy

Conditions
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Chronic Pain, Acute Pain

Intervention / Treatment
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* Procedure: nerve block
* Procedure: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Eligible patients fit an ASA I or II classification adult patients who will be scheduled for elective thyroid lobectomy under general anaesthesia. Exclusion Criteria: hypersensitivity to any study drugs Long-term use of anticoagulant drugs: warfarin or heparin the neck or systemic infection communication disorder refuse to accept this research subjects.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: nerve block<br>cervical plexus block with ropivacaine | Procedure: nerve block<br>* After general anaesthesia,the patient is placed in a supine position with the head turn away from the side to be blocked, and then the sternocleidomastoid muscle (SCM) is identified by slight head elevation. SCPB(superficial cervical plexus block) is performed with a 26-gauge needle that is inserted at the midpoint of the posterior border of the SCM muscle and the needle is advanced just past the SCM muscle. The mixture is prepared with 20ml of 0.5% ropivacaine in Group 1<br>|
| Placebo Comparator: Placebo<br>placebo saline | Procedure: placebo<br>* After general anaesthesia,the patient is placed in a supine position with the head turn away from the side to be blocked, and then the sternocleidomastoid muscle (SCM) is identified by slight head elevation. SCPB(superficial cervical plexus block) is performed with a 26-gauge needle that is inserted at the midpoint of the posterior border of the SCM muscle and the needle is advanced just past the SCM muscle. The mixture is prepared with 20ml of 0.9% saline in Group 2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of chronic postsurgery pain | the time from the end of surgery | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the intensity of acute pain | swallowing pain and rest pain | 24 hours | 
| hemodynamic stability | blood pressure and heart rate intraoperative responses. | 1 day | 
| postoperative nausea and vomiting |  | 2 days after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic postsurgery pain, acute pain