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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Steffen, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT00472446
First received: May 10, 2007
Last updated: July 27, 2016
Last verified: July 2016
Results First Received: November 24, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition: Thyroidectomy
Interventions: Drug: bilateral superficial cervical block
Drug: placebo bilateral superficial cervical block

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cervivcal Block Before Surgery

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

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.

Cervivcal Block After Surgery

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

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 Cervivcal Block Before Surgery

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

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.

Placebo Cervivcal Block After Surgery

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

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.


Participant Flow:   Overall Study
    Cervivcal Block Before Surgery   Cervivcal Block After Surgery   Placebo Cervivcal Block Before Surgery   Placebo Cervivcal Block After Surgery
STARTED   46   47   45   45 
COMPLETED   41   41   38   39 
NOT COMPLETED   5   6   7   6 
Protocol Violation                0                0                0                1 
Reintervention                0                0                1                1 
Questionnaires not returned                5                6                6                4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cervivcal Block Before Surgery

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

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.

Cervivcal Block After Surgery

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

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 Cervivcal Block Before Surgery

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

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.

Placebo Cervivcal Block After Surgery

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

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.

Total Total of all reporting groups

Baseline Measures
   Cervivcal Block Before Surgery   Cervivcal Block After Surgery   Placebo Cervivcal Block Before Surgery   Placebo Cervivcal Block After Surgery   Total 
Overall Participants Analyzed 
[Units: Participants]
 41   41   38   39   159 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.1  (14.0)   46.5  (13.3)   49.9  (13.5)   47.3  (14.4)   48.2  (13.7) 
Gender 
[Units: Participants]
         
Female   33   36   29   31   129 
Male   8   5   9   8   30 
Region of Enrollment 
[Units: Participants]
         
Switzerland   41   41   38   39   159 
resection location 
[Units: Participants]
         
unilateral   18   22   24   26   90 
bilateral   23   19   14   13   69 
duration of surgery 
[Units: Minutes]
Mean (Standard Deviation)
 140.8  (48.1)   130.5  (37.0)   129.6  (48.1)   141.9  (50.4)   135.7  (45.7) 
specimen weight 
[Units: Gram]
Mean (Standard Deviation)
 60.4  (55.1)   42.2  (32.0)   51.0  (43.6)   39.8  (41.2)   47.0  (43.4) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Post-operative Pain Measured by Visual Analogue Scale   [ Time Frame: 6 hours after surgery ]

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

3.  Secondary:   Post-operative Pain Measured by Visual Analogue Scale   [ Time Frame: 24 hours after surgery ]

4.  Secondary:   Consumption of Post-operative Analgetics   [ Time Frame: 5 days after surgery ]

5.  Secondary:   Mean Consumption of Post-operative Analgetics   [ Time Frame: 5 days after surgery ]

6.  Secondary:   Hospital Stay   [ Time Frame: 90 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Thomas Steffen, MD
Organization: Cantonal Hospital St. Gallen
phone: 0041 71 494 1111
e-mail: thomas.steffen@kssg.ch


Publications of Results:

Responsible Party: Thomas Steffen, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT00472446     History of Changes
Other Study ID Numbers: EKSG 06/010/1B
2006DR4184 ( Other Identifier: SwissMedic )
Study First Received: May 10, 2007
Results First Received: November 24, 2015
Last Updated: July 27, 2016
Health Authority: Switzerland: Swissmedic