Regional Anesthesia for Thyroidectomy

NCT02108834 | Unknown DMC

• 1 other identifier: GZFPH-IRB-2013-085
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Pain; Acute Pain

Keywords

chronic postsurgery pain; acute pain

Outcome Measures

Primary Outcomes (1)

• the incidence of chronic postsurgery pain

  the time from the end of surgery

  60 days

Secondary Outcomes (3)

• the intensity of acute pain

  24 hours

• hemodynamic stability

  1 day

• postoperative nausea and vomiting

  2 days after operation

Other Outcomes (1)

• The over-all satisfaction of patients

  24 hours

Study Arms (2)

nerve block

ACTIVE COMPARATOR

cervical plexus block with ropivacaine

Procedure: nerve block

Placebo

PLACEBO COMPARATOR

placebo saline

Procedure: placebo

Interventions

nerve block PROCEDURE

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

nerve block

placebo PROCEDURE

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou First People's Hospital: lead

Study Sites (2)

Guangzhou First Municipal People's Hospital

Guangzhou, 510180, China

ACTIVE NOT RECRUITING

Guangzhou First Municipal People's Hospital

Guangzhou, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 16698416 BACKGROUND

• 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.

  PMID: 11375842 BACKGROUND

• 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.

  PMID: 18931238 RESULT

MeSH Terms

Conditions

Chronic Pain; Acute Pain

Interventions

Nerve Block

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Xiangcai Ruan, MD, PHD

  Guangzhou First Municipal People's Hospital,Guangzhou,Guangdong,China,510180

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangcai Ruan, MD,PHD

CONTACT

+8620-81048306; xc_ruan@hotmail.com

Yuan Lin, MD, Msc

CONTACT

+8620-81048306; linyuan1117@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice chair

Study Record Dates

• First Submitted: April 4, 2014
• First Posted: April 9, 2014
• Study Start: April 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: January 21, 2015

Record last verified: 2015-01

Locations

CN (2)