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

Cantonal Hospital of St. Gallen

Status and phase: Completed; Phase 3; Phase 2

Conditions: Thyroidectomy

Treatments: Drug: bilateral superficial cervical block; Drug: placebo bilateral superficial cervical block

Study type: Interventional

Funder types: Other

Identifiers

NCT00472446

2006DR4184 (Other Identifier)

EKSG 06/010/1B

Details and patient eligibility

About

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.

Enrollment: 183 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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183 participants in 4 patient groups, including a placebo group

cervical block before surgery

Experimental group

Description:

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

Treatment:

Drug: bilateral superficial cervical block

placebo cervical block before surgery

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo bilateral superficial cervical block

cervical block after surgery

Experimental group

Description:

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

Treatment:

Drug: bilateral superficial cervical block

placebo cervical block after surgery

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo bilateral superficial cervical block