Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00472446
Recruitment Status : Completed
First Posted : May 11, 2007
Results First Posted : September 15, 2016
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Thomas Steffen, Cantonal Hospital of St. Gallen

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Thyroidectomy Drug: bilateral superficial cervical block Drug: placebo bilateral superficial cervical block Phase 2 Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Impact and Cost Efficiency of Bilateral, Superficial Cervical Block in Thyroid Surgery Under General Anesthesia
Study Start Date : January 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Post-operative Pain Measured by Visual Analogue Scale [ Time Frame: 6 hours after surgery ]
    Patient administered Instrument to indicate pain on a level from 0 to 10. (0: no pain, 10: worst imaginable pain)

  2. Pooled Relative Treatment Effect of VAS [ Time Frame: 4 days after surgery ]

    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 :
  1. Post-operative Pain Measured by Visual Analogue Scale [ Time Frame: 24 hours after surgery ]
    Patient administered Instrument to indicate pain on a level from 0 to 10. (0: no pain, 10: worst imaginable pain)

  2. Consumption of Post-operative Analgetics [ Time Frame: 5 days after surgery ]
    number of participants taking post-operative analgetics

  3. Mean Consumption of Post-operative Analgetics [ Time Frame: 5 days after surgery ]
    mean pooled dose of post-operative analgetics

  4. Hospital Stay [ Time Frame: 90 days ]
    time from surgery to Hospital release in days


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00472446


Locations
Layout table for location information
Switzerland
Department of Surgery, Cantonal Hospital of St. Gallen
St. Gallen, Switzerland, 9007
Sponsors and Collaborators
Cantonal Hospital of St. Gallen
Investigators
Layout table for investigator information
Principal Investigator: Thomas Clerici, MD Department of Surgery, Cantonal Hospital St. Gallen
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Thomas Steffen, attending surgeon, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT00472446    
Other Study ID Numbers: EKSG 06/010/1B
2006DR4184 ( Other Identifier: SwissMedic )
First Posted: May 11, 2007    Key Record Dates
Results First Posted: September 15, 2016
Last Update Posted: September 15, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Thomas Steffen, Cantonal Hospital of St. Gallen:
Surgery
Thyroid gland
cervical block
Pain, Postoperative
Additional relevant MeSH terms:
Layout table for MeSH terms
Thyroid Diseases
Endocrine System Diseases