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| ID | Type | Description | Link |
|---|---|---|---|
| 2006DR4184 | Other Identifier | SwissMedic |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cervical block before surgery | Experimental | bilateral superficial cervical block, placed before surgery (just before skin incision) |
|
| placebo cervical block before surgery | Placebo Comparator | placebo bilateral superficial cervical block with saline, placed before surgery (just before skin incision) |
|
| cervical block after surgery | Experimental | bilateral superficial cervical block, placed after surgery (just after skin closure) |
|
| placebo cervical block after surgery | Placebo Comparator | placebo bilateral superficial cervical block with saline, placed after surgery (just after skin closure) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 4 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 24 hours after surgery |
| Consumption of Post-operative Analgetics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Clerici, MD | Department of Surgery, Cantonal Hospital St. Gallen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Cantonal Hospital of St. Gallen | Sankt Gallen | 9007 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20632263 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cervivcal Block Before Surgery | bilateral superficial cervical block placed before surgery (just before skin incision) 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. |
| FG001 | Cervivcal Block After Surgery | bilateral superficial cervical block placed after surgery (just after skin closure) 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. |
| FG002 | Placebo Cervivcal Block Before Surgery | placebo bilateral superficial cervical block placed before surgery (just before skin incision) 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. |
| FG003 | Placebo Cervivcal Block After Surgery | placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure) 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cervivcal Block Before Surgery | bilateral superficial cervical block placed before surgery (just before skin incision) 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | Standard Deviation | units on a scale | 6 hours after surgery |
|
6 weeks after surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cervivcal Block Before Surgery | bilateral superficial cervical block placed before surgery (just before skin incision) 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hemorrhage | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Steffen, MD | Cantonal Hospital St. Gallen | 0041 71 494 1111 | thomas.steffen@kssg.ch |
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| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 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. |
|
number of participants taking post-operative analgetics
| 5 days after surgery |
| Mean Consumption of Post-operative Analgetics | mean pooled dose of post-operative analgetics | 5 days after surgery |
| Hospital Stay | time from surgery to Hospital release in days | 90 days |
| Reintervention |
|
| Questionnaires not returned |
|
| BG001 | Cervivcal Block After Surgery | bilateral superficial cervical block placed after surgery (just after skin closure) 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. |
| BG002 | Placebo Cervivcal Block Before Surgery | placebo bilateral superficial cervical block placed before surgery (just before skin incision) 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. |
| BG003 | Placebo Cervivcal Block After Surgery | placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure) 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| resection location | Number | participants |
|
| duration of surgery | Mean | Standard Deviation | minutes |
|
| specimen weight | Mean | Standard Deviation | gram |
|
bilateral superficial cervical block placed after surgery (just after skin closure) 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. |
| OG002 | Placebo Cervivcal Block Before Surgery | placebo bilateral superficial cervical block placed before surgery (just before skin incision) 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. |
| OG003 | Placebo Cervivcal Block After Surgery | placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure) 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. |
|
|
|
| Primary | 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) | Posted | Number | 95% Confidence Interval | pooled relative treatment effect | 4 days after surgery |
|
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | units on a scale | 24 hours after surgery |
|
|
|
| Secondary | Consumption of Post-operative Analgetics | number of participants taking post-operative analgetics | Posted | Number | participants | 5 days after surgery |
|
|
|
|
| Secondary | Mean Consumption of Post-operative Analgetics | mean pooled dose of post-operative analgetics | Posted | Mean | Standard Deviation | gram | 5 days after surgery |
|
|
|
|
| Secondary | Hospital Stay | time from surgery to Hospital release in days | Posted | Mean | Standard Deviation | days | 90 days |
|
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Cervivcal Block After Surgery | bilateral superficial cervical block placed after surgery (just after skin closure) 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. | 0 | 41 | 0 | 41 |
| EG002 | Placebo Cervivcal Block Before Surgery | placebo bilateral superficial cervical block placed before surgery (just before skin incision) 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. | 0 | 38 | 0 | 38 |
| EG003 | Placebo Cervivcal Block After Surgery | placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure) 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. | 1 | 39 | 0 | 39 |
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
null hypothesis: no difference in outcome measure pre-operative versus post-operative application |
| Non-parametric ANOVA-type statistic |
Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model |
| 0.723 |
| No |
| Superiority or Other |
| metamizole |
|
null hypothesis: outcome measure (Proportion of patients taking analgetics) is equal between superficial cervical block and placebo treatment (irrespective of timing) Proportion taking Metamizole: |
| Fisher Exact |
mid p value of two-sided Fisher test |
| 0.58 |
| 2-Sided |
| No |
| Superiority or Other |
| metamizole |
|
null hypothesis: no difference in pooled dose of analgetics, superficial block versus Placebo outcome: metamizole |
| Non-parametric ANOVA-type |
Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model |
| 0.81 |
| 2-Sided |
| No |
| Superiority or Other |
| null hypothesis: no difference in outcome measure pre-operative and post-operative application outcome measure: pooled paracetamol dose | Non-parametric ANOVA-type statistic | Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model | 0.331 | 2-Sided | No | Superiority or Other |
| null hypothesis: no difference in outcome measure pre-operative and post-operative application outcome measure: pooled metamizole dose | Non-parametric ANOVA-type statistic | Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model | 0.440 | 2-Sided | No | Superiority or Other |