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

Primary Purpose

Thyroidectomy

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
bilateral superficial cervical block
placebo bilateral superficial cervical block
Sponsored by
Cantonal Hospital of St. Gallen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Thyroidectomy focused on measuring Surgery, Thyroid gland, cervical block, Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Surgery, Cantonal Hospital of St. Gallen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

cervical block before surgery

placebo cervical block before surgery

cervical block after surgery

placebo cervical block after surgery

Arm Description

bilateral superficial cervical block, placed before surgery (just before skin incision)

placebo bilateral superficial cervical block with saline, placed before surgery (just before skin incision)

bilateral superficial cervical block, placed after surgery (just after skin closure)

placebo bilateral superficial cervical block with saline, placed after surgery (just after skin closure)

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

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)
Consumption of Post-operative Analgetics
number of participants taking post-operative analgetics
Mean Consumption of Post-operative Analgetics
mean pooled dose of post-operative analgetics
Hospital Stay
time from surgery to Hospital release in days

Full Information

First Posted
May 10, 2007
Last Updated
July 27, 2016
Sponsor
Cantonal Hospital of St. Gallen
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1. Study Identification

Unique Protocol Identification Number
NCT00472446
Brief Title
Superficial, Cervical Block in Thyroid Surgery, a Randomized Controlled Trial
Official Title
Impact and Cost Efficiency of Bilateral, Superficial Cervical Block in Thyroid Surgery Under General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cantonal Hospital of St. Gallen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroidectomy
Keywords
Surgery, Thyroid gland, cervical block, Pain, Postoperative

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cervical block before surgery
Arm Type
Experimental
Arm Description
bilateral superficial cervical block, placed before surgery (just before skin incision)
Arm Title
placebo cervical block before surgery
Arm Type
Placebo Comparator
Arm Description
placebo bilateral superficial cervical block with saline, placed before surgery (just before skin incision)
Arm Title
cervical block after surgery
Arm Type
Experimental
Arm Description
bilateral superficial cervical block, placed after surgery (just after skin closure)
Arm Title
placebo cervical block after surgery
Arm Type
Placebo Comparator
Arm Description
placebo bilateral superficial cervical block with saline, placed after surgery (just after skin closure)
Intervention Type
Drug
Intervention Name(s)
bilateral superficial cervical block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo bilateral superficial cervical block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post-operative Pain Measured by Visual Analogue Scale
Description
Patient administered Instrument to indicate pain on a level from 0 to 10. (0: no pain, 10: worst imaginable pain)
Time Frame
6 hours after surgery
Title
Pooled Relative Treatment Effect of VAS
Description
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)
Time Frame
4 days after surgery
Secondary Outcome Measure Information:
Title
Post-operative Pain Measured by Visual Analogue Scale
Description
Patient administered Instrument to indicate pain on a level from 0 to 10. (0: no pain, 10: worst imaginable pain)
Time Frame
24 hours after surgery
Title
Consumption of Post-operative Analgetics
Description
number of participants taking post-operative analgetics
Time Frame
5 days after surgery
Title
Mean Consumption of Post-operative Analgetics
Description
mean pooled dose of post-operative analgetics
Time Frame
5 days after surgery
Title
Hospital Stay
Description
time from surgery to Hospital release in days
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Clerici, MD
Organizational Affiliation
Department of Surgery, Cantonal Hospital St. Gallen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Cantonal Hospital of St. Gallen
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20632263
Citation
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.
Results Reference
result

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

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