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Analgesic Efficacy of Bilateral Superficial Cervical Plexus Block in Robot-assisted Endoscopic Thyroidectomy Using a Transaxillary Approach

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01325857
First received: March 28, 2011
Last updated: February 26, 2012
Last verified: February 2012
History of Changes
  Purpose

This study was designed to investigate the analgesic effect of bilateral superficial cervical plexus block in patients undergoing robot-assisted endoscopic thyroidectomy. The investigators hypothesized that bilateral superficial cervical plexus blockade would reduce the patient's pain score by more than 10 (on a VAS scale of 0~100) compared to a placebo group and control group.


Condition Intervention
Thyroid Cancer
 Procedure: Bilateral superficial cervical plexus block
Procedure: placebo
Procedure: Control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Analgesic Efficacy of Bilateral Superficial Cervical Plexus Block in Robot-assisted Endoscopic Thyroidectomy Using a Transaxillary Approach

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Visual analogue pain score [ Time Frame: Immediate post-operation (at recovery room) (day 1) ] [ Designated as safety issue: No ]

Enrollment: 97
Study Start Date: January 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group B
Group B = Nerve block group
 Procedure: Bilateral superficial cervical plexus block
Bilateral superficial cervical plexus block with 0.525% ropivacaine 20ml
Placebo Comparator: Group L
Group L = Local wound infiltration group
 Procedure: placebo
Procedure: Bilateral superficial cervical plexus block with normal saline 20ml
Active Comparator: Group C
Group C = Control group
 Procedure: Control group
Procedure: Local anesthetic infiltration at incision site with 0.525% ropivacaine 20ml

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA class 1 or 2 adult patients scheduled for robot-assisted endoscopic thyroidectomy

Exclusion Criteria:

  • Patient refusal
  • Bleeding diathesis
  • Allergies to local anesthetics
  • Patient unable to read consent form (Foreigner, illiterate)
  • Pregnant women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01325857

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided by Yonsei University

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

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01325857     History of Changes
Other Study ID Numbers: 4-2010-0668
Study First Received: March 28, 2011
Last Updated: February 26, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013