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

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ClinicalTrials.gov Identifier: NCT01325857
Recruitment Status : Completed
First Posted : March 30, 2011
Last Update Posted : February 28, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Thyroid Cancer Procedure: Bilateral superficial cervical plexus block Procedure: placebo Procedure: Control group

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Analgesic Efficacy of Bilateral Superficial Cervical Plexus Block in Robot-assisted Endoscopic Thyroidectomy Using a Transaxillary Approach
Study Start Date : January 2011
Primary Completion Date : February 2012
Study Completion Date : February 2012
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Visual analogue pain score [ Time Frame: Immediate post-operation (at recovery room) (day 1) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325857


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

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
First Posted: March 30, 2011    Key Record Dates
Last Update Posted: February 28, 2012
Last Verified: February 2012

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