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Bilateral Superficial Cervical Block for Thyroidectomy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Lifecenter Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01171885
First Posted: July 29, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Federal University of Minas Gerais
Information provided by:
Lifecenter Hospital
  Purpose
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.

Condition Intervention Phase
Cervical Pain Drug: 0.9% saline Drug: Ropivacaine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Lifecenter Hospital:

Primary Outcome Measures:
  • Post operative pain assessment according to Visual Analogue Scale [ Time Frame: 24 Hours ]

Secondary Outcome Measures:
  • Consumption of morphine [ Time Frame: 24 Hours ]

Estimated Enrollment: 120
Study Start Date: July 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Bilateral superficial cervical block.
Drug: 0.9% saline
20 ml of 0.9% saline
Experimental: Ropivacaine 0.25%
Bilateral superficial cervical block
Drug: Ropivacaine
20 ml of Ropivacaine 0.25%.
Experimental: Ropivacaine 0.5%
Bilateral superficial cervical block.
Drug: Ropivacaine
20 ml of Ropivacaine 0.5%.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01171885


Contacts
Contact: Carlos Leonardo A Boni, MD 00553191851959 leonardoboni@gmail.com
Contact: Yerkes P Silva, PhD 00553199933384 yerkesps@uol.com.br

Locations
Brazil
Lifecenter Hospital Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30110090
Contact: Carlos leonardo A Boni, MD    00553191851959    leonardoboni@gmail.com   
Contact: Yerkes P Silva, PhD    00553199933384    yerkesps@uol.com.br   
Sub-Investigator: Yerkes P Silva, PhD         
Sub-Investigator: Renato S Gomez, PhD         
Principal Investigator: Carlos Leonardo A Boni, MD         
Sponsors and Collaborators
Lifecenter Hospital
Federal University of Minas Gerais
Investigators
Principal Investigator: Carlos Leonardo A Boni, MD Federal University of Minas Gerais
  More Information

Publications:
Responsible Party: Carlos Leonardo Alves Boni, Lifecenter Hospital
ClinicalTrials.gov Identifier: NCT01171885     History of Changes
Other Study ID Numbers: CAAE-0003.0.419.419-0
First Submitted: July 28, 2010
First Posted: July 29, 2010
Last Update Posted: October 12, 2017
Last Verified: May 2009

Keywords provided by Lifecenter Hospital:
Superficial cervical block
Thyroidectomy
Pain

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents