Bilateral Superficial Cervical Block for Thyroidectomy

July 28, 2010 updated by: Lifecenter Hospital

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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%.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30110090
        • Recruiting
        • Lifecenter Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Yerkes P Silva, PhD
        • Sub-Investigator:
          • Renato S Gomez, PhD
        • Principal Investigator:
          • Carlos Leonardo A Boni, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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%.
Drug: Ropivacaine
20 ml of Ropivacaine 0.5%.
Experimental: Ropivacaine 0.5%
Bilateral superficial cervical block.
Drug: Ropivacaine
20 ml of Ropivacaine 0.25%.
Drug: Ropivacaine
20 ml of Ropivacaine 0.5%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post operative pain assessment according to Visual Analogue Scale
Time Frame: 24 Hours
24 Hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Consumption of morphine
Time Frame: 24 Hours
24 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lifecenter Hospital

Collaborators

Federal University of Minas Gerais

Investigators

  • Principal Investigator: Carlos Leonardo A Boni, MD, Federal University of Minas Gerais

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

July 28, 2010

First Submitted That Met QC Criteria

July 28, 2010

First Posted (Estimate)

July 29, 2010

Study Record Updates

Last Update Posted (Estimate)

July 29, 2010

Last Update Submitted That Met QC Criteria

July 28, 2010

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE-0003.0.419.419-0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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