Regional Anesthesia for Thyroidectomy
Primary Purpose
Chronic Pain, Acute Pain
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
nerve block
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring chronic postsurgery pain, acute pain
Eligibility Criteria
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.
Sites / Locations
- Guangzhou First Municipal People's Hospital
- Guangzhou First Municipal People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
nerve block
Placebo
Arm Description
cervical plexus block with ropivacaine
placebo saline
Outcomes
Primary Outcome Measures
the incidence of chronic postsurgery pain
the time from the end of surgery
Secondary Outcome Measures
the intensity of acute pain
swallowing pain and rest pain
hemodynamic stability
blood pressure and heart rate intraoperative responses.
postoperative nausea and vomiting
Full Information
NCT ID
NCT02108834
First Posted
April 4, 2014
Last Updated
January 19, 2015
Sponsor
Guangzhou First People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02108834
Brief Title
Regional Anesthesia for Thyroidectomy
Official Title
Randomized Controlled Trial of Regional Anesthesia in Combination With General Anesthesia for Thyroidectomy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
March 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou First People's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Acute Pain
Keywords
chronic postsurgery pain, acute pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
79 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nerve block
Arm Type
Active Comparator
Arm Description
cervical plexus block with ropivacaine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo saline
Intervention Type
Procedure
Intervention Name(s)
nerve block
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
the incidence of chronic postsurgery pain
Description
the time from the end of surgery
Time Frame
60 days
Secondary Outcome Measure Information:
Title
the intensity of acute pain
Description
swallowing pain and rest pain
Time Frame
24 hours
Title
hemodynamic stability
Description
blood pressure and heart rate intraoperative responses.
Time Frame
1 day
Title
postoperative nausea and vomiting
Time Frame
2 days after operation
Other Pre-specified Outcome Measures:
Title
The over-all satisfaction of patients
Description
The over-all satisfaction of patients after the surgery
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangcai Ruan, MD,PHD
Phone
+8620-81048306
Email
xc_ruan@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan Lin, MD, Msc
Phone
+8620-81048306
Email
linyuan1117@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiangcai Ruan, MD, PHD
Organizational Affiliation
Guangzhou First Municipal People's Hospital,Guangzhou,Guangdong,China,510180
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou First Municipal People's Hospital
City
Guangzhou
ZIP/Postal Code
510180
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Guangzhou First Municipal People's Hospital
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangcai Ruan
Phone
8620-81048306
Email
xc_ruan@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yuan Lin
Phone
8620-81048310
Email
linyuan1117@163.com
First Name & Middle Initial & Last Name & Degree
Xiangcai Ruan
First Name & Middle Initial & Last Name & Degree
Yuan Lin
First Name & Middle Initial & Last Name & Degree
Chengxiang Lu
First Name & Middle Initial & Last Name & Degree
Lixin Xu
First Name & Middle Initial & Last Name & Degree
Shouzhang She
12. IPD Sharing Statement
Citations:
PubMed Identifier
16698416
Citation
Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
Results Reference
background
PubMed Identifier
11375842
Citation
Dieudonne N, Gomola A, Bonnichon P, Ozier YM. Prevention of postoperative pain after thyroid surgery: a double-blind randomized study of bilateral superficial cervical plexus blocks. Anesth Analg. 2001 Jun;92(6):1538-42. doi: 10.1097/00000539-200106000-00038.
Results Reference
background
PubMed Identifier
18931238
Citation
Brogly N, Wattier JM, Andrieu G, Peres D, Robin E, Kipnis E, Arnalsteen L, Thielemans B, Carnaille B, Pattou F, Vallet B, Lebuffe G. Gabapentin attenuates late but not early postoperative pain after thyroidectomy with superficial cervical plexus block. Anesth Analg. 2008 Nov;107(5):1720-5. doi: 10.1213/ane.0b013e318185cf73.
Results Reference
result
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Regional Anesthesia for Thyroidectomy
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