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Cervical Block in Thyroid Surgery

This study has been completed.
Sponsor:
Information provided by:
Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT00472446
First received: May 10, 2007
Last updated: December 17, 2008
Last verified: December 2008
History of Changes
  Purpose

The study investigates the impact on post-operative pain of the superficial cervical block with bupivacaine combined with subcutaneous infiltration of the incisional area in thyroid surgery under general anesthesia. In addition, cost savings using the cervical block are evaluated (due to reduced length of hospital stay).

The study is prospective, randomized, double blind, and placebo-controlled. The study is performed at the Department of Surgery, Cantonal Hospital of St. Gallen.


Condition Intervention Phase
Thyroidectomy
 Procedure: superficial cervical block
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: Impact and Cost Efficiency of Bilateral, Superficial Cervical Block in Thyroid Surgery Under General Anesthesia

Resource links provided by NLM:

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid
U.S. FDA Resources

Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • post-operative pain measured by visual analogue scale [ Time Frame: 5 days after surgery ]

Secondary Outcome Measures:
  • consumption of post operative analgetics [ Time Frame: 5 days after surgery ]

Estimated Enrollment: 200
Study Start Date: January 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective thyroid or combined thyroid/parathyroid surgery, restricted to the central cervical compartment
  • Informed consent

Exclusion Criteria:

  • Intolerance to used medication
  • Recurrent disease
  • Neck dissection, sternotomy
  • Emergency surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00472446

Locations
Switzerland
Department of Surgery, Cantonal Hospital of St. Gallen
St. Gallen, Switzerland, 9007
Sponsors and Collaborators
Cantonal Hospital of St. Gallen
Investigators
Principal Investigator: Thomas Clerici, MD Department of Surgery, Cantonal Hospital St. Gallen
  More Information

No publications provided by Cantonal Hospital of St. Gallen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00472446     History of Changes
Other Study ID Numbers: EKSG 06/010/1B, 2006DR4184
Study First Received: May 10, 2007
Last Updated: December 17, 2008
Health Authority: Switzerland: Swissmedic

Keywords provided by Cantonal Hospital of St. Gallen:
Surgery
Thyroid gland
cervical block
Pain, Postoperative

ClinicalTrials.gov processed this record on May 22, 2013