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Bilateral Superficial Cervical Block for Thyroidectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Lifecenter Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Federal University of Minas Gerais
Information provided by:
Lifecenter Hospital
ClinicalTrials.gov Identifier:
NCT01171885
First received: July 28, 2010
Last updated: NA
Last verified: May 2009
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Lifecenter Hospital:

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

Secondary Outcome Measures:
  • Consumption of morphine [ Time Frame: 24 Hours ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 28, 2010
Last Updated: July 28, 2010
Health Authority: Brazil: National Committee of Ethics in Research

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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013