Superficial, Cervical Block in Thyroid Surgery, a Randomized Controlled Trial

Impact and Cost Efficiency of Bilateral, Superficial Cervical Block in Thyroid Surgery Under General Anesthesia

The study investigates the impact on post-operative pain of the superficial cervical block with bupivacaine combined with subcutaneous infiltration of the incisional area in thyroid surgery under general anesthesia. In addition, cost savings using the cervical block are evaluated (due to reduced length of hospital stay).

The study is prospective, randomized, double blind, and placebo-controlled. The study is performed at the Department of Surgery, Cantonal Hospital of St. Gallen.

Study Overview

• Status: Completed
• Conditions: Thyroidectomy
• Intervention / Treatment: Drug: bilateral superficial cervical block; Drug: placebo bilateral superficial cervical block

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Switzerland
  • St. Gallen, Switzerland, 9007
    • Department of surgery, Cantonal hospital of St. Gallen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Elective thyroid or combined thyroid/parathyroid surgery, restricted to the central cervical compartment
• Informed consent

Exclusion Criteria:

• Intolerance to used medication
• Recurrent disease
• Neck dissection, sternotomy
• Emergency surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cervical block before surgery; bilateral superficial cervical block, placed before surgery (just before skin incision)	Drug: bilateral superficial cervical block; 10 ml of 5% bupivacaine (Carbostesin®) was used for each side. Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side.
Placebo Comparator: placebo cervical block before surgery; placebo bilateral superficial cervical block with saline, placed before surgery (just before skin incision)	Drug: placebo bilateral superficial cervical block; 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side. Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side.
Experimental: cervical block after surgery; bilateral superficial cervical block, placed after surgery (just after skin closure)	Drug: bilateral superficial cervical block; 10 ml of 5% bupivacaine (Carbostesin®) was used for each side. Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side.
Placebo Comparator: placebo cervical block after surgery; placebo bilateral superficial cervical block with saline, placed after surgery (just after skin closure)	Drug: placebo bilateral superficial cervical block; 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side. Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Pain Measured by Visual Analogue Scale	Patient administered Instrument to indicate pain on a level from 0 to 10. (0: no pain, 10: worst imaginable pain)	6 hours after surgery
Pooled Relative Treatment Effect of VAS	Pain was obtained using the visual analog scale (VAS) three times daily for the 4 postoperative days (0 = no pain, 10 = worst imaginable pain) The pooled relative treatment effect is the probability of values being higher in one group than in another group (ranging from 0 to 1)	4 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Pain Measured by Visual Analogue Scale	Patient administered Instrument to indicate pain on a level from 0 to 10. (0: no pain, 10: worst imaginable pain)	24 hours after surgery
Consumption of Post-operative Analgetics	number of participants taking post-operative analgetics	5 days after surgery
Mean Consumption of Post-operative Analgetics	mean pooled dose of post-operative analgetics	5 days after surgery
Hospital Stay	time from surgery to Hospital release in days	90 days

Collaborators and Investigators

• Sponsor: Cantonal Hospital of St. Gallen
• Investigators: Principal Investigator: Thomas Clerici, MD, Department of Surgery, Cantonal Hospital St. Gallen

Publications and helpful links

General Publications

• Steffen T, Warschkow R, Brandle M, Tarantino I, Clerici T. Randomized controlled trial of bilateral superficial cervical plexus block versus placebo in thyroid surgery. Br J Surg. 2010 Jul;97(7):1000-6. doi: 10.1002/bjs.7077.

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: May 10, 2007
• First Submitted That Met QC Criteria: May 10, 2007
• First Posted (Estimate): May 11, 2007

Study Record Updates

• Last Update Posted (Estimate): September 15, 2016
• Last Update Submitted That Met QC Criteria: July 27, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Surgery; Pain, Postoperative; cervical block; Thyroid gland
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: EKSG 06/010/1B; 2006DR4184 (Other Identifier: SwissMedic)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO