Regional Anesthesia for Thyroidectomy

January 19, 2015 updated by: Xiangcai Ruan, Guangzhou First People's Hospital

Randomized Controlled Trial of Regional Anesthesia in Combination With General Anesthesia for Thyroidectomy

For more than 25 years, Regional Anesthesia has challenged anesthesiologists to determine whether it offers real benefits in terms of patient outcome from major surgery, compared with general anesthesia. Although it is clear that regional analgesia in association with general anesthesia substantially reduces postoperative pain, the benefits in terms of overall perioperative outcome are controversial. The aim of this study is to evaluate the effect on short and long-term postoperative outcomes of adding regional analgesia to general anaesthesia in thoridetomic patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients who are divided into two treatment groups: (a) a bilateral superficial cervical plexus group (group S) and a control group (group C).We performe bilateral superficial cervical plexus block (BSCPB)with 0.25-0.75% ropivacaine10 ml to group S and 10ml NaCl 0.9% to group C. All BSCPB is performed by experienced anesthesia doctor after a standardized induction of general anaesthesia.eneral anaesthesia was induced by using intravenously with midazolam,propofol, fentanyl, cisatracurium is injected IV to facilitate orotracheal intubation. After a standardized induction of general anaesthesia, patients receive Regional Anesthesia at the discretion of the experienced anesthesiologist who was blinded to treatment.

The patient is placed in a supine position with the head turned away from the side to be blocked, and then the sternocleidomastoid muscle (SCM) is identified by slight head elevation. SCPB is performed with a 26-gauge needle that is inserted at the midpoint of the posterior border of the SCM muscle and the needle is advanced just past the SCM muscle.

Study Type

Interventional

Enrollment (Anticipated)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Guangzhou, China
        • Recruiting
        • Guangzhou First Municipal People's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiangcai Ruan
        • Sub-Investigator:
          • Yuan Lin
        • Sub-Investigator:
          • Chengxiang Lu
        • Sub-Investigator:
          • Lixin Xu
        • Sub-Investigator:
          • Shouzhang She
      • Guangzhou, China, 510180
        • Active, not recruiting
        • Guangzhou First Municipal People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-Eligible patients fit an ASA I or II classification adult patients who will be scheduled for elective thyroid lobectomy under general anaesthesia.

Exclusion Criteria:

  • hypersensitivity to any study drugs
  • Long-term use of anticoagulant drugs: warfarin or heparin
  • the neck or systemic infection
  • communication disorder
  • refuse to accept this research subjects.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: nerve block
cervical plexus block with ropivacaine
Procedure: nerve block
After general anaesthesia,the patient is placed in a supine position with the head turn away from the side to be blocked, and then the sternocleidomastoid muscle (SCM) is identified by slight head elevation. SCPB(superficial cervical plexus block) is performed with a 26-gauge needle that is inserted at the midpoint of the posterior border of the SCM muscle and the needle is advanced just past the SCM muscle. The mixture is prepared with 20ml of 0.5% ropivacaine in Group 1
PLACEBO_COMPARATOR: Placebo
placebo saline
Procedure: placebo
After general anaesthesia,the patient is placed in a supine position with the head turn away from the side to be blocked, and then the sternocleidomastoid muscle (SCM) is identified by slight head elevation. SCPB(superficial cervical plexus block) is performed with a 26-gauge needle that is inserted at the midpoint of the posterior border of the SCM muscle and the needle is advanced just past the SCM muscle. The mixture is prepared with 20ml of 0.9% saline in Group 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of chronic postsurgery pain
Time Frame: 60 days
the time from the end of surgery
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the intensity of acute pain
Time Frame: 24 hours
swallowing pain and rest pain
24 hours
hemodynamic stability
Time Frame: 1 day
blood pressure and heart rate intraoperative responses.
1 day
postoperative nausea and vomiting
Time Frame: 2 days after operation
2 days after operation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The over-all satisfaction of patients
Time Frame: 24 hours
The over-all satisfaction of patients after the surgery
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou First People's Hospital

Investigators

  • Principal Investigator: Xiangcai Ruan, MD, PHD, Guangzhou First Municipal People's Hospital,Guangzhou,Guangdong,China,510180

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ANTICIPATED)

February 1, 2015

Study Completion (ANTICIPATED)

March 1, 2015

Study Registration Dates

First Submitted

April 4, 2014

First Submitted That Met QC Criteria

April 6, 2014

First Posted (ESTIMATE)

April 9, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 21, 2015

Last Update Submitted That Met QC Criteria

January 19, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GZFPH-IRB-2013-085

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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