CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 183 enrolled
Drug / intervention
bilateral superficial cervical block +1 moredrug
Likely dose
Bupivacaine 5% (10 ml per side, 2.5 ml per deposit × 3 deposits)AI-extracted
Key inclusion· 2
  • Elective thyroid or combined thyroid/parathyroid surgery limited to central cervical compartment
  • Informed consent required
Key exclusion· 4
  • Intolerance to bupivacaine or saline
  • Recurrent thyroid or parathyroid disease
  • Neck dissection or sternotomy procedures
  • Emergency surgery

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00472446
NCT00472446Phase 3Completed

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

Cantonal Hospital of St. Gallen·interventional·Posted May 11, 2007·Updated Sep 15, 2016

In Brief

A Phase 3 clinical trial evaluating bilateral superficial cervical block and placebo bilateral superficial cervical block for Thyroidectomy. Completed, enrolled 183 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThyroidectomy
CountriesSwitzerland
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 11, 2007
Enrollment StartJan 1, 2006
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 19.1 years ago

Interventions

bilateral superficial cervical blockdrug

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 blockdrug

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.