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

NCT ID: NCT01325857

Last Updated: 2012-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Thyroid Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group B

Group B = Nerve block group

Group Type EXPERIMENTAL

Bilateral superficial cervical plexus block

Intervention Type PROCEDURE

Bilateral superficial cervical plexus block with 0.525% ropivacaine 20ml

Group L

Group L = Local wound infiltration group

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type PROCEDURE

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

Group C

Group C = Control group

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type PROCEDURE

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

Interventions

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Bilateral superficial cervical plexus block

Bilateral superficial cervical plexus block with 0.525% ropivacaine 20ml

Intervention Type PROCEDURE

placebo

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

Intervention Type PROCEDURE

Control group

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 22956016 (View on PubMed)

Other Identifiers

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4-2010-0668

Identifier Type: -

Identifier Source: org_study_id

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