Regional Anesthesia for Thyroidectomy

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02108834
• Other study ID #: GZFPH-IRB-2013-085
• Status: Recruiting
• Phase: N/A
• First received: April 4, 2014
• Last updated: January 19, 2015
• Start date: April 2014
• Est. completion date: March 2015

Study information

• Verified date: January 2015
• Source: Guangzhou First Municipal People’s Hospital
• Contact: Xiangcai Ruan, MD,PHD
• Phone: +8620-81048306
• Email: xc_ruan[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 79
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain

Intervention

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
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.

Locations

Country	Name	City	State
China	Guangzhou First Municipal People's Hospital	Guangzhou
China	Guangzhou First Municipal People's Hospital	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou First Municipal People’s Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. An — View 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. — View Citation

Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The over-all satisfaction of patients	The over-all satisfaction of patients after the surgery	24 hours	No
Primary	the incidence of chronic postsurgery pain	the time from the end of surgery	60 days	No
Secondary	the intensity of acute pain	swallowing pain and rest pain	24 hours	Yes
Secondary	hemodynamic stability	blood pressure and heart rate intraoperative responses.	1 day	Yes
Secondary	postoperative nausea and vomiting		2 days after operation	Yes