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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

May 10, 2007
July 27, 2016
January 2006
December 2008   (final data collection date for primary outcome measure)
  • Post-operative Pain Measured by Visual Analogue Scale [ Time Frame: 6 hours after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 days after surgery ] [ Designated as safety issue: No ]

    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)

Post-operative Pain Measured by Visual Analogue Scale [ Time Frame: 5 days after surgery ]
Complete list of historical versions of study NCT00472446 on ClinicalTrials.gov Archive Site
  • Post-operative Pain Measured by Visual Analogue Scale [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: 5 days after surgery ] [ Designated as safety issue: No ]
    number of participants taking post-operative analgetics
  • Mean Consumption of Post-operative Analgetics [ Time Frame: 5 days after surgery ] [ Designated as safety issue: No ]
    mean pooled dose of post-operative analgetics
  • Hospital Stay [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    time from surgery to Hospital release in days
Consumption of Post-operative Analgetics [ Time Frame: 5 days after surgery ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Thyroidectomy
  • 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.
  • 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 before surgery
    bilateral superficial cervical block, placed before surgery (just before skin incision)
    Intervention: Drug: bilateral superficial cervical block
  • Placebo Comparator: placebo cervical block before surgery
    placebo bilateral superficial cervical block with saline, placed before surgery (just before skin incision)
    Intervention: Drug: placebo bilateral superficial cervical block
  • Experimental: cervical block after surgery
    bilateral superficial cervical block, placed after surgery (just after skin closure)
    Intervention: Drug: bilateral superficial cervical block
  • Placebo Comparator: placebo cervical block after surgery
    placebo bilateral superficial cervical block with saline, placed after surgery (just after skin closure)
    Intervention: Drug: placebo bilateral superficial cervical block
Steffen T, Warschkow R, Brändle 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
183
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00472446
EKSG 06/010/1B, 2006DR4184
No
No
Not Provided
Thomas Steffen, Cantonal Hospital of St. Gallen
Cantonal Hospital of St. Gallen
Not Provided
Principal Investigator: Thomas Clerici, MD Department of Surgery, Cantonal Hospital St. Gallen
Cantonal Hospital of St. Gallen
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP