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Regional Anesthesia for Thyroidectomy

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02108834
Enrollment
79
Registered
2014-04-09
Start date
2014-04-30
Completion date
2015-03-31
Last updated
2015-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain, Chronic Pain

Keywords

chronic postsurgery pain, acute pain

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.

Interventions

PROCEDUREnerve 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

PROCEDUREplacebo

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.

Sponsors

Guangzhou First People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
the incidence of chronic postsurgery pain60 daysthe time from the end of surgery

Secondary

MeasureTime frameDescription
the intensity of acute pain24 hoursswallowing pain and rest pain
hemodynamic stability1 dayblood pressure and heart rate intraoperative responses.
postoperative nausea and vomiting2 days after operation

Other

MeasureTime frameDescription
The over-all satisfaction of patients24 hoursThe over-all satisfaction of patients after the surgery

Countries

China

Contacts

Primary ContactXiangcai Ruan, MD,PHD
xc_ruan@hotmail.com+8620-81048306
Backup ContactYuan Lin, MD, Msc
linyuan1117@163.com+8620-81048306

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026