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To compare efficacy and safety between bilateral superficial cervical plexus block combined with intravenous sedation (RA group) and general anesthesia (GA group) for thyroid and parathyroid operations. This study evaluates postoperative numerical pain score and systemic opioid requirement within 24 hours.
According to literature review, there is limit information about efficacy and safety of thyroid and parathyroid operations under bilateral superficial cervical plexus block combined with intravenous sedation without general anesthesia. General anesthesia is commonly used for neck operations because it is easy to perform. However in high cardiovascular or pulmonary risk patients such as end stage renal disease (ESRD) patients, regional anesthesia such as superficial cervical plexus block combined with intravenous sedation have become an alternative technique for neck operations.
This study evaluate whether regional anesthesia (RA) technique can be the alternative technique for thyroid/parathyroid surgery compare to conventional technique (GA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bilateral cervical plexus block | Experimental | bilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 0.25% bupivacaine 16 mg) |
|
| General anesthesia | Experimental | General anesthesia with endotracheal intubation under total intravenous anesthesia (TIVA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 16 ml) | Procedure | bilateral superficial cervical plexus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain score at rest | Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable) | 0 hour at PACU ( time PACU arrival) |
| Postoperative pain score at rest | Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable) | 1 hours at PACU |
| Postoperative pain score at rest | Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable) | 6 hours at ward |
| Postoperative pain score at rest | Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable) | 12 hours at ward |
| Postoperative pain score at rest | Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable) | 18 hours at ward |
| Postoperative pain score at rest | Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable) | 24 hours at ward |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain score on swallow | Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable) | 1 hour PACU |
| Postoperative pain score on swallow | Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable) |
| Measure | Description | Time Frame |
|---|---|---|
| Conversion rate from RA to GA | Inable operation due to pain or movement, need to convert from RA toGA | intraoperation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suwimon Tangwiwat, MD | Contact | +66816456167 | stangwiwat@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Suwimon Tangwiwat, MD | Siriraj Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Siriraj Hospital, Mahidol University | Recruiting | Bangkok Noi | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27687375 | Background | Ueshima H, Hara E, Hiroshi O. RETRACTED: Successful cases of thyroid surgery performed under only bilateral cervical plexus blocks. J Clin Anesth. 2016 Nov;34:206. doi: 10.1016/j.jclinane.2016.04.014. Epub 2016 May 11. No abstract available. |
|
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|
| Dexmedetomidine plus propofol infusion | Drug | Dexmedetomidine 0.5 ug/kg infusion in 10 min then 0.5 ug/kg/h, Propofol infusion |
|
|
| Local infiltraion analgesia | Procedure | local infiltration analgesia with 2%lidocaine with adrenaline 5 ug/ml 10 ml |
|
|
| General anesthesia with endotracheal tube | Procedure | Induction with Propofol and intubation with cisatracurium |
|
|
| average NRS at ward at 24 hours |
| Postoperative morphine consumption | in milligram | Cumulative dose within 24 hours |
| Complications | Percentage of patients present with hoarseness, dyspnea, local anaesthetic systemic toxicity | within 24 hours |
| Patient's satisfaction scale score | satisfaction scale score 0-10 ( 0= highly unsatisfied, 10= highly satisfied) | at 24 hours |
| Background |
| Wang Q, Li Z, Xu S, Li Y, Zhang X, Liu Q, Xia Y, Papadimos TJ, Xu X. Feasibility of ultrasound-guided capsule-sheath space block combined with anterior cervical cutaneous nerves block for thyroidectomy: an observational pilot study. BMC Anesthesiol. 2015 Jan 19;15(1):4. doi: 10.1186/1471-2253-15-4. eCollection 2015. |
| 19571762 | Background | Suh YJ, Kim YS, In JH, Joo JD, Jeon YS, Kim HK. Comparison of analgesic efficacy between bilateral superficial and combined (superficial and deep) cervical plexus block administered before thyroid surgery. Eur J Anaesthesiol. 2009 Dec;26(12):1043-7. doi: 10.1097/EJA.0b013e32832d6913. |
| 22971490 | Background | Cai HD, Lin CZ, Yu CX, Lin XZ. Bilateral superficial cervical plexus block reduces postoperative nausea and vomiting and early postoperative pain after thyroidectomy. J Int Med Res. 2012;40(4):1390-8. doi: 10.1177/147323001204000417. |
| 20037182 | Background | Ingsathit A, Thakkinstian A, Chaiprasert A, Sangthawan P, Gojaseni P, Kiattisunthorn K, Ongaiyooth L, Vanavanan S, Sirivongs D, Thirakhupt P, Mittal B, Singh AK; Thai-SEEK Group. Prevalence and risk factors of chronic kidney disease in the Thai adult population: Thai SEEK study. Nephrol Dial Transplant. 2010 May;25(5):1567-75. doi: 10.1093/ndt/gfp669. Epub 2009 Dec 27. |
| 16125070 | Background | Spanknebel K, Chabot JA, DiGiorgi M, Cheung K, Lee S, Allendorf J, Logerfo P. Thyroidectomy using local anesthesia: a report of 1,025 cases over 16 years. J Am Coll Surg. 2005 Sep;201(3):375-85. doi: 10.1016/j.jamcollsurg.2005.04.034. |
| 2774445 | Background | Yerzingatsian KL. Thyroidectomy under local analgesia: the anatomical basis of cervical blocks. Ann R Coll Surg Engl. 1989 Jul;71(4):207-10. |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D020927 | Dexmedetomidine |
| D016292 | Conscious Sedation |
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |
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