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NCT Number: NCT00472446

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

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.

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Key information

Conditions

Thyroidectomy Endocrine System Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Surgery, Cantonal Hospital of St. Gallen

Sankt Gallen, 9007, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bilateral superficial cervical block

Drug

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 bilateral superficial cervical block

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cantonal Hospital of St. Gallen

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
May 11, 2007
Registry last updated
Sep 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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