NCT01325857

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 30, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 28, 2012

Status Verified

February 1, 2012

Enrollment Period

1.1 years

First QC Date

March 28, 2011

Last Update Submit

February 26, 2012

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

  • Visual analogue pain score

    Immediate post-operation (at recovery room) (day 1)

Study Arms (3)

Group B

EXPERIMENTAL

Group B = Nerve block group

Procedure: Bilateral superficial cervical plexus block

Group L

PLACEBO COMPARATOR

Group L = Local wound infiltration group

Procedure: placebo

Group C

ACTIVE COMPARATOR

Group C = Control group

Procedure: Control group

Interventions

Bilateral superficial cervical plexus blockPROCEDURE

Bilateral superficial cervical plexus block with 0.525% ropivacaine 20ml

Group B
placeboPROCEDURE

Procedure: Bilateral superficial cervical plexus block with normal saline 20ml

Group L
Control groupPROCEDURE

Procedure: Local anesthetic infiltration at incision site with 0.525% ropivacaine 20ml

Group C

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patient refusal
  • Bleeding diathesis
  • Allergies to local anesthetics
  • Patient unable to read consent form (Foreigner, illiterate)
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 22956016DERIVED

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2011

First Posted

March 30, 2011

Study Start

January 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

February 28, 2012

Record last verified: 2012-02

Locations

KR(1)