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Bilateral Superficial Cervical Block for Thyroidectomy

Primary Purpose

Cervical Pain

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
0.9% saline
Ropivacaine
Ropivacaine
Sponsored by
Lifecenter Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Pain focused on measuring Superficial cervical block, Thyroidectomy, Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lifecenter HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Ropivacaine 0.25%

Ropivacaine 0.5%

Arm Description

Bilateral superficial cervical block.

Bilateral superficial cervical block

Bilateral superficial cervical block.

Outcomes

Primary Outcome Measures

Post operative pain assessment according to Visual Analogue Scale

Secondary Outcome Measures

Consumption of morphine

Full Information

First Posted
July 28, 2010
Last Updated
July 28, 2010
Sponsor
Lifecenter Hospital
Collaborators
Federal University of Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT01171885
Brief Title
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

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Lifecenter Hospital
Collaborators
Federal University of Minas Gerais

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Pain
Keywords
Superficial cervical block, Thyroidectomy, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Bilateral superficial cervical block.
Arm Title
Ropivacaine 0.25%
Arm Type
Experimental
Arm Description
Bilateral superficial cervical block
Arm Title
Ropivacaine 0.5%
Arm Type
Experimental
Arm Description
Bilateral superficial cervical block.
Intervention Type
Drug
Intervention Name(s)
0.9% saline
Intervention Description
20 ml of 0.9% saline
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
20 ml of Ropivacaine 0.25%.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
20 ml of Ropivacaine 0.5%.
Primary Outcome Measure Information:
Title
Post operative pain assessment according to Visual Analogue Scale
Time Frame
24 Hours
Secondary Outcome Measure Information:
Title
Consumption of morphine
Time Frame
24 Hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Leonardo A Boni, MD
Phone
00553191851959
Email
leonardoboni@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yerkes P Silva, PhD
Phone
00553199933384
Email
yerkesps@uol.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Leonardo A Boni, MD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lifecenter Hospital
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30110090
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos leonardo A Boni, MD
Phone
00553191851959
Email
leonardoboni@gmail.com
First Name & Middle Initial & Last Name & Degree
Yerkes P Silva, PhD
Phone
00553199933384
Email
yerkesps@uol.com.br
First Name & Middle Initial & Last Name & Degree
Yerkes P Silva, PhD
First Name & Middle Initial & Last Name & Degree
Renato S Gomez, PhD
First Name & Middle Initial & Last Name & Degree
Carlos Leonardo A Boni, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
17681971
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.
Results Reference
background
PubMed Identifier
16418022
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.
Results Reference
background
PubMed Identifier
16551919
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.
Results Reference
background
PubMed Identifier
20632263
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.
Results Reference
background

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Bilateral Superficial Cervical Block for Thyroidectomy

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