ThyroidectomyPhase 2/3NCT00472446

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

A Phase 2/3 study testing bilateral superficial cervical block in people with Thyroidectomy, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Thyroidectomy
What is being tested?: bilateral superficial cervical block
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 183 participants
Where: 1 siteSwitzerland
Study dates: Jan 2006to Dec 2008
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Elective thyroid or combined thyroid/parathyroid surgery, restricted to the central cervical compartment
Informed consent

Who cannot join

Intolerance to used medication
Recurrent disease
Neck dissection, sternotomy
Emergency surgery

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

Department of Surgery, Cantonal Hospital of St. Gallen
Sankt Gallen, 9007

Other trials in Switzerland

About this study

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

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
Being tested: bilateral superficial cervical block, placebo bilateral superficial cervical block
Keywords: Surgery, Thyroid gland, cervical block, Pain, Postoperative
Medical subject headings: Thyroid Diseases, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT00472446
Study group	Role	What they receive
cervical block before surgery	Experimental	bilateral superficial cervical block, placed before surgery (just before skin incision) Receives: Drug: bilateral superficial cervical block
placebo cervical block before surgery	Placebo comparator	placebo bilateral superficial cervical block with saline, placed before surgery (just before skin incision) Receives: Drug: placebo bilateral superficial cervical block
cervical block after surgery	Experimental	bilateral superficial cervical block, placed after surgery (just after skin closure) Receives: Drug: bilateral superficial cervical block
placebo cervical block after surgery	Placebo comparator	placebo bilateral superficial cervical block with saline, placed after surgery (just after skin closure) Receives: Drug: placebo bilateral superficial cervical block

What is being measured

The primary outcome is the main question the study is designed to answer.

Post-operative Pain Measured by Visual Analogue Scale
Patient administered Instrument to indicate pain on a level from 0 to 10. (0: no pain, 10: worst imaginable pain)
Measured: 6 hours after surgery
Pooled Relative Treatment Effect of VAS
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)
Measured: 4 days after surgery

Secondary outcomes (4)

Post-operative Pain Measured by Visual Analogue Scale
Patient administered Instrument to indicate pain on a level from 0 to 10. (0: no pain, 10: worst imaginable pain)
Measured: 24 hours after surgery
Consumption of Post-operative Analgetics
number of participants taking post-operative analgetics
Measured: 5 days after surgery
Mean Consumption of Post-operative Analgetics
mean pooled dose of post-operative analgetics
Measured: 5 days after surgery
Hospital Stay
time from surgery to Hospital release in days
Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2006Dec 2008

First posted11 May 2007 (estimated)
Study startJan 2006
Primary completionDec 2008
Study completionDec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ThyroidectomyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 183 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00472446
Sponsor's protocol ID: EKSG 06/010/1B
Other IDs: 2006DR4184
Status last verified: Jul 2016
First submitted: 10 May 2007
Last updated: 15 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 20632263

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Effect of Cold Water Spray on Swallowing Difficulty, Pain, and Thirst After Thyroid Surgery
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Opioid-Free Versus Opioid-Based Anesthesia in Thyroid Surgery
Thyroidectomy, Oxidative Stress
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Evaluation of Levothyroxine Replacement Therapy After Total Thyroidectomy Using a Smart Wristband
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Active, not recruiting
Effects of Dexmedetomidine Combined With Lidocaine Topical Administration on Cough Reflex During Extubation in Thyroidectomy Patient.
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Not yet recruiting
Effects of Therapeutic Exercise With and Without Nerve Stimulation on Dysphonia in Post Thyroidectomy Patients
Post-Thyroidectomy Dysphonia

All Thyroidectomy trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact and Cost Efficiency of Bilateral, Superficial Cervical Block in Thyroid Surgery Under General Anesthesia
ClinicalTrials.gov ID: NCT00472446
Acronym / sponsor ID: EKSG 06/010/1B
Conditions: Thyroidectomy
Keywords: Surgery, Thyroid gland, cervical block, Pain, Postoperative
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 183 participants (actual)
Lead sponsor: Cantonal Hospital of St. GallenUniversity, hospital or other
Study start: Jan 2006
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 11 May 2007 (estimated)
Results: Posted 15 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
cervical block before surgery	Experimental	Drug: bilateral superficial cervical blockbilateral superficial cervical block, placed before surgery (just before skin incision)
placebo cervical block before surgery	Placebo comparator	Drug: placebo bilateral superficial cervical blockplacebo bilateral superficial cervical block with saline, placed before surgery (just before skin incision)
cervical block after surgery	Experimental	Drug: bilateral superficial cervical blockbilateral superficial cervical block, placed after surgery (just after skin closure)
placebo cervical block after surgery	Placebo comparator	Drug: placebo bilateral superficial cervical blockplacebo bilateral superficial cervical block with saline, placed after surgery (just after skin closure)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Elective thyroid or combined thyroid/parathyroid surgery, restricted to the central cervical compartment
Informed consent

Key exclusion criteria (4 listed)

Intolerance to used medication
Recurrent disease
Neck dissection, sternotomy
Emergency surgery

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
bilateral superficial cervical block10 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.	Drug	cervical block after surgery, cervical block before surgery
placebo bilateral superficial cervical block10 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.	Drug	placebo cervical block after surgery, placebo cervical block before surgery

Primary outcome

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)
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)

4 secondary outcomes

Post-operative Pain Measured by Visual Analogue Scale
Time frame: 24 hours after surgery
Consumption of Post-operative Analgetics
Time frame: 5 days after surgery
Mean Consumption of Post-operative Analgetics
Time frame: 5 days after surgery
Hospital Stay
Time frame: 90 days

Results and safety

Results posted to the registry on 15 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cervivcal Block Before Surgery	46	41
Cervivcal Block After Surgery	47	41
Placebo Cervivcal Block Before Surgery	45	38
Placebo Cervivcal Block After Surgery	45	39

Primary outcome: Post-operative Pain Measured by Visual Analogue Scale

Time frame: 6 hours after surgery. Mean (Standard Deviation). Unit: units on a scale

Measure	Cervivcal Block Before Surgery n = 41	Cervivcal Block After Surgery n = 41	Placebo Cervivcal Block Before Surgery n = 38	Placebo Cervivcal Block After Surgery n = 39
Value	2.15 (2.17)	2.02 (2.06)	2.84 (1.75)	2.72 (1.89)

Cervivcal Block Before Surgery vs Cervivcal Block After Surgery vs Placebo Cervivcal Block Before Surgery vs Placebo Cervivcal Block After Surgery: p = .028, t-test, 2 sided

Primary outcome: Pooled Relative Treatment Effect of VAS

Time frame: 4 days after surgery. Number (95% Confidence Interval). Unit: pooled relative treatment effect

Measure	Cervivcal Block Before Surgery n = 41	Cervivcal Block After Surgery n = 41	Placebo Cervivcal Block Before Surgery n = 38	Placebo Cervivcal Block After Surgery n = 39
Value	0.47 (0.43 to 0.51)	0.45 (0.41 to 0.48)	0.55 (0.51 to 0.59)	0.54 (0.51 to 0.58)

Cervivcal Block Before Surgery vs Cervivcal Block After Surgery vs Placebo Cervivcal Block Before Surgery vs Placebo Cervivcal Block After Surgery: p = 0.016, Non-parametric ANOVA-type statistic
Cervivcal Block Before Surgery vs Cervivcal Block After Surgery: p = 0.723, Non-parametric ANOVA-type statistic

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks after surgery. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cervivcal Block Before Surgery	0 of 41 (0%)	0 of 41 (0%)	Not reported
Cervivcal Block After Surgery	0 of 41 (0%)	0 of 41 (0%)	Not reported
Placebo Cervivcal Block Before Surgery	0 of 38 (0%)	0 of 38 (0%)	Not reported
Placebo Cervivcal Block After Surgery	1 of 39 (2.6%)	0 of 39 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20632263Steffen 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.
Individual participant dataSharing planned: No

Related trials for Thyroidectomy

Enrolling by invitation
Effect of Cold Water Spray on Swallowing Difficulty, Pain, and Thirst After Thyroid Surgery
Swallowing Difficulties, Thirst
Recruiting
Opioid-Free Versus Opioid-Based Anesthesia in Thyroid Surgery
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Evaluation of Levothyroxine Replacement Therapy After Total Thyroidectomy Using a Smart Wristband
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Effects of Dexmedetomidine Combined With Lidocaine Topical Administration on Cough Reflex During Extubation in Thyroidectomy Patient.
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Not yet recruiting
Effects of Therapeutic Exercise With and Without Nerve Stimulation on Dysphonia in Post Thyroidectomy Patients
Post-Thyroidectomy Dysphonia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas Clerici, MD principal investigator

Department of Surgery, Cantonal Hospital St. Gallen

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing bilateral superficial cervical block in people with Thyroidectomy, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-operative Pain Measured by Visual Analogue Scale (time frame: 6 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00472446, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2016; AzTrials last refreshed its copy on 27 Oct 2026.