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

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01325857
• Other study ID #: 4-2010-0668
• Status: Completed
• Phase: N/A
• First received: March 28, 2011
• Last updated: February 26, 2012
• Start date: January 2011
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Neoplasms

Intervention

Procedure:
• Bilateral superficial cervical plexus block
Bilateral superficial cervical plexus block with 0.525% ropivacaine 20ml
• placebo
Procedure: Bilateral superficial cervical plexus block with normal saline 20ml
• Control group
Procedure: Local anesthetic infiltration at incision site with 0.525% ropivacaine 20ml

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analogue pain score		Immediate post-operation (at recovery room) (day 1)	No