Clinical trial NCT02108834: Regional Anesthesia for Thyroidectomy
Official title: Randomized Controlled Trial of Regional Anesthesia in Combination With General Anesthesia for Thyroidectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Acute Pain
Keywords: chronic postsurgery pain
acute pain
Lead sponsor: Guangzhou First People's Hospital
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: the incidence of chronic postsurgery pain
timeFrame: 60 days
Secondary outcomes:
measure: the intensity of acute pain
timeFrame: 24 hours
measure: hemodynamic stability
timeFrame: 1 day
measure: postoperative nausea and vomiting
timeFrame: 2 days after operation
Other outcomes:
measure: The over-all satisfaction of patients
timeFrame: 24 hours
Locations:
city: Guangzhou
country: China
facility: Guangzhou First Municipal People's Hospital
city: Guangzhou
country: China
facility: Guangzhou First Municipal People's Hospital
Study officials:
affiliation: Guangzhou First Municipal People's Hospital,Guangzhou,Guangdong,China,510180
name: Xiangcai Ruan, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.