NCT01171885

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

July 29, 2010

Status Verified

May 1, 2009

Enrollment Period

2.4 years

First QC Date

July 28, 2010

Last Update Submit

July 28, 2010

Conditions

Cervical Pain

Keywords

Superficial cervical blockThyroidectomyPain

Outcome Measures

Primary Outcomes (1)

  • Post operative pain assessment according to Visual Analogue Scale

    24 Hours

Secondary Outcomes (1)

  • Consumption of morphine

    24 Hours

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Bilateral superficial cervical block.

Drug: 0.9% saline

Ropivacaine 0.25%

EXPERIMENTAL

Bilateral superficial cervical block

Drug: Ropivacaine

Ropivacaine 0.5%

EXPERIMENTAL

Bilateral superficial cervical block.

Drug: Ropivacaine

Interventions

0.9% salineDRUG

20 ml of 0.9% saline

Placebo
RopivacaineDRUG

20 ml of Ropivacaine 0.25%.

Ropivacaine 0.25%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lifecenter Hospital

Belo Horizonte, Minas Gerais, 30110090, Brazil

RECRUITING

Related Publications (4)

  • 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.

    PMID: 17681971BACKGROUND

  • 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.

    PMID: 16418022BACKGROUND

  • 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.

    PMID: 16551919BACKGROUND

  • 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.

    PMID: 20632263BACKGROUND

MeSH Terms

Conditions

Neck PainPain

Interventions

Saline SolutionRopivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Carlos Leonardo A Boni, MD

    Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Leonardo A Boni, MD

CONTACT

00553191851959leonardoboni@gmail.com

Yerkes P Silva, PhD

CONTACT

00553199933384yerkesps@uol.com.br

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 28, 2010

First Posted

July 29, 2010

Study Start

July 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

July 29, 2010

Record last verified: 2009-05

Locations

BR(1)