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

Primary Purpose

Thyroid Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bilateral superficial cervical plexus block
placebo
Control group
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thyroid Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Group B

Group L

Group C

Arm Description

Group B = Nerve block group

Group L = Local wound infiltration group

Group C = Control group

Outcomes

Primary Outcome Measures

Visual analogue pain score

Secondary Outcome Measures

Full Information

First Posted
March 28, 2011
Last Updated
February 26, 2012
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01325857
Brief Title
Analgesic Efficacy of Bilateral Superficial Cervical Plexus Block in Robot-assisted Endoscopic Thyroidectomy Using a Transaxillary Approach
Official Title
Analgesic Efficacy of Bilateral Superficial Cervical Plexus Block in Robot-assisted Endoscopic Thyroidectomy Using a Transaxillary Approach
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group B
Arm Type
Experimental
Arm Description
Group B = Nerve block group
Arm Title
Group L
Arm Type
Placebo Comparator
Arm Description
Group L = Local wound infiltration group
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Group C = Control group
Intervention Type
Procedure
Intervention Name(s)
Bilateral superficial cervical plexus block
Intervention Description
Bilateral superficial cervical plexus block with 0.525% ropivacaine 20ml
Intervention Type
Procedure
Intervention Name(s)
placebo
Intervention Description
Procedure: Bilateral superficial cervical plexus block with normal saline 20ml
Intervention Type
Procedure
Intervention Name(s)
Control group
Intervention Description
Procedure: Local anesthetic infiltration at incision site with 0.525% ropivacaine 20ml
Primary Outcome Measure Information:
Title
Visual analogue pain score
Time Frame
Immediate post-operation (at recovery room) (day 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22956016
Citation
Shin S, Chung WY, Jeong JJ, Kang SW, Oh YJ. Analgesic efficacy of bilateral superficial cervical plexus block in robot-assisted endoscopic thyroidectomy using a transaxillary approach. World J Surg. 2012 Dec;36(12):2831-7. doi: 10.1007/s00268-012-1780-0.
Results Reference
derived

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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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