Clinical trial NCT01171885: Bilateral Superficial Cervical Block for Thyroidectomy
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cervical Pain
Keywords: Superficial cervical block
Thyroidectomy
Pain
Lead sponsor: Lifecenter Hospital
Sponsor class: OTHER
Collaborators: name: Federal University of Minas Gerais
First posted: 2010-07-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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%.

Eligibility criteria: 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

Primary outcomes:
measure: Post operative pain assessment according to Visual Analogue Scale
timeFrame: 24 Hours
Secondary outcomes:
measure: Consumption of morphine
timeFrame: 24 Hours
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Lifecenter Hospital
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais
name: Carlos Leonardo A Boni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andrieu G, Amrouni H, Robin E, Carnaille B, Wattier JM, Pattou F, Vallet B, Lebuffe G. Analgesic efficacy of bilateral superficial cervical plexus block administered before thyroid surgery under general anaesthesia. Br J Anaesth. 2007 Oct;99(4):561-6. doi: 10.1093/bja/aem230. Epub 2007 Aug 6.
citation: Herbland A, Cantini O, Reynier P, Valat P, Jougon J, Arimone Y, Janvier G. The bilateral superficial cervical plexus block with 0.75% ropivacaine administered before or after surgery does not prevent postoperative pain after total thyroidectomy. Reg Anesth Pain Med. 2006 Jan-Feb;31(1):34-9. doi: 10.1016/j.rapm.2005.10.008.
citation: Eti Z, Irmak P, Gulluoglu BM, Manukyan MN, Gogus FY. Does bilateral superficial cervical plexus block decrease analgesic requirement after thyroid surgery? Anesth Analg. 2006 Apr;102(4):1174-6. doi: 10.1213/01.ane.0000202383.51830.c4.
citation: Steffen T, Warschkow R, Brandle M, Tarantino I, Clerici T. Randomized controlled trial of bilateral superficial cervical plexus block versus placebo in thyroid surgery. Br J Surg. 2010 Jul;97(7):1000-6. doi: 10.1002/bjs.7077.