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

NCT ID: NCT00472446

Last Updated: 2016-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2008-12-31

Brief Summary

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.

Conditions

Thyroidectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

cervical block before surgery

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

Group Type: EXPERIMENTAL

bilateral superficial cervical block

Intervention Type: 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 cervical block before surgery

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

Group Type: PLACEBO_COMPARATOR

placebo bilateral superficial cervical block

Intervention Type: 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.

cervical block after surgery

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

Group Type: EXPERIMENTAL

bilateral superficial cervical block

Intervention Type: 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 cervical block after surgery

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

Group Type: PLACEBO_COMPARATOR

placebo bilateral superficial cervical block

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role: lead

Responsible Party

Thomas Steffen

attending surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Clerici, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, Cantonal Hospital St. Gallen

Locations

Department of Surgery, Cantonal Hospital of St. Gallen

Sankt Gallen, , Switzerland

Countries

Switzerland

References

Steffen T, Warschkow R, Brandle 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.

Reference Type: RESULT

PMID: 20632263 (View on PubMed)

Other Identifiers

2006DR4184

Identifier Type: OTHER

Identifier Source: secondary_id

EKSG 06/010/1B

Identifier Type: -

Identifier Source: org_study_id