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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
  Purpose

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 Intervention Phase
Thyroidectomy
Drug: bilateral superficial cervical block
Drug: placebo bilateral superficial cervical block
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • 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)



Secondary Outcome Measures:
  • 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


Enrollment: 183
Study Start Date: January 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472446

Locations
Switzerland
Department of Surgery, Cantonal Hospital of St. Gallen
St. Gallen, Switzerland, 9007
Sponsors and Collaborators
Cantonal Hospital of St. Gallen
Investigators
Principal Investigator: Thomas Clerici, MD Department of Surgery, Cantonal Hospital St. Gallen
  More Information

Publications:
Responsible Party: Thomas Steffen, attending surgeon, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT00472446     History of Changes
Other Study ID Numbers: EKSG 06/010/1B  2006DR4184 
Study First Received: May 10, 2007
Results First Received: November 24, 2015
Last Updated: July 27, 2016
Health Authority: Switzerland: Swissmedic
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Cantonal Hospital of St. Gallen:
Surgery
Thyroid gland
cervical block
Pain, Postoperative

ClinicalTrials.gov processed this record on December 02, 2016