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

• Sponsor: Cantonal Hospital of St. Gallen (Other)
• Overall Status: Completed
• CT.gov ID: NCT00472446
• Collaborator: (none)
• Enrollment: 183
• Location: 1
• Arms: 4
• Duration (Months): 35
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroidectomy	Drug: bilateral superficial cervical block; Drug: placebo bilateral superficial cervical block	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 183 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Impact and Cost Efficiency of Bilateral, Superficial Cervical Block in Thyroid Surgery Under General Anesthesia
• Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: cervical block before surgery bilateral superficial cervical block, placed before surgery (just before skin incision)	Drug: 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.
Placebo Comparator: placebo cervical block before surgery placebo bilateral superficial cervical block with saline, placed before surgery (just before skin incision)	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.
Experimental: cervical block after surgery bilateral superficial cervical block, placed after surgery (just after skin closure)	Drug: 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.
Placebo Comparator: placebo cervical block after surgery placebo bilateral superficial cervical block with saline, placed after surgery (just after skin closure)	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.

Outcome Measures

Primary Outcome Measures

1. Post-operative Pain Measured by Visual Analogue Scale [6 hours after surgery]

   Patient administered Instrument to indicate pain on a level from 0 to 10. (0: no pain, 10: worst imaginable pain)

2. Pooled Relative Treatment Effect of VAS [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)

Secondary Outcome Measures

1. Post-operative Pain Measured by Visual Analogue Scale [24 hours after surgery]

   Patient administered Instrument to indicate pain on a level from 0 to 10. (0: no pain, 10: worst imaginable pain)

2. Consumption of Post-operative Analgetics [5 days after surgery]

   number of participants taking post-operative analgetics

3. Mean Consumption of Post-operative Analgetics [5 days after surgery]

   mean pooled dose of post-operative analgetics

4. Hospital Stay [90 days]

   time from surgery to Hospital release in days

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Surgery, Cantonal Hospital of St. Gallen	St. Gallen		Switzerland	9007

Sponsors and Collaborators

• Cantonal Hospital of St. Gallen

Investigators

• Principal Investigator: Thomas Clerici, MD, Department of Surgery, Cantonal Hospital St. Gallen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thomas Steffen, attending surgeon, Cantonal Hospital of St. Gallen
• ClinicalTrials.gov Identifier: NCT00472446
• Other Study ID Numbers: EKSG 06/010/1B; 2006DR4184
• First Posted: May 11, 2007
• Last Update Posted: Sep 15, 2016
• Last Verified: Jul 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Thomas Steffen, attending surgeon, Cantonal Hospital of St. Gallen: Surgery; Thyroid gland; cervical block; Pain, Postoperative
• Additional relevant MeSH terms: Thyroid Diseases

Study Results

Participant Flow

Arm/Group Title	Cervivcal Block Before Surgery	Cervivcal Block After Surgery	Placebo Cervivcal Block Before Surgery	Placebo Cervivcal Block After Surgery
Arm/Group Description	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.	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.	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.	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.
Period Title: Overall Study
STARTED	46	47	45	45
COMPLETED	41	41	38	39
NOT COMPLETED	5	6	7	6

Baseline Characteristics

Arm/Group Title	Cervivcal Block Before Surgery	Cervivcal Block After Surgery	Placebo Cervivcal Block Before Surgery	Placebo Cervivcal Block After Surgery	Total
Arm/Group Description	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.	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.	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.	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.	Total of all reporting groups
Overall Participants	41	41	38	39	159
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.1 (14.0)	46.5 (13.3)	49.9 (13.5)	47.3 (14.4)	48.2 (13.7)
Sex: Female, Male (Count of Participants)
Female	33 80.5%	36 87.8%	29 76.3%	31 79.5%	129 81.1%
Male	8 19.5%	5 12.2%	9 23.7%	8 20.5%	30 18.9%
Region of Enrollment (participants) [Number]
Switzerland	41 100%	41 100%	38 100%	39 100%	159 100%
resection location (participants) [Number]
unilateral	18 43.9%	22 53.7%	24 63.2%	26 66.7%	90 56.6%
bilateral	23 56.1%	19 46.3%	14 36.8%	13 33.3%	69 43.4%
duration of surgery (minutes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [minutes]	140.8 (48.1)	130.5 (37.0)	129.6 (48.1)	141.9 (50.4)	135.7 (45.7)
specimen weight (gram) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [gram]	60.4 (55.1)	42.2 (32.0)	51.0 (43.6)	39.8 (41.2)	47.0 (43.4)

Outcome Measures

1. Primary Outcome

Title	Post-operative Pain Measured by Visual Analogue Scale
Description	Patient administered Instrument to indicate pain on a level from 0 to 10. (0: no pain, 10: worst imaginable pain)
Time Frame	6 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cervivcal Block Before Surgery	Cervivcal Block After Surgery	Placebo Cervivcal Block Before Surgery	Placebo Cervivcal Block After Surgery
Arm/Group Description	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.	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.	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.	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.
Measure Participants	41	41	38	39
Mean (Standard Deviation) [units on a scale]	2.15 (2.17)	2.02 (2.06)	2.84 (1.75)	2.72 (1.89)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cervivcal Block Before Surgery, Cervivcal Block After Surgery, Placebo Cervivcal Block Before Surgery, Placebo Cervivcal Block After Surgery
	Comments	null hypothesis: no difference in outcome measure between superficial cervical block and placebo treatment (irrespective of timing of treatment)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.028
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Pooled Relative Treatment Effect of VAS
Description	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)
Time Frame	4 days after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cervivcal Block Before Surgery	Cervivcal Block After Surgery	Placebo Cervivcal Block Before Surgery	Placebo Cervivcal Block After Surgery
Arm/Group Description	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.	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.	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.	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.
Measure Participants	41	41	38	39
Number (95% Confidence Interval) [pooled relative treatment effect]	0.47	0.45	0.55	0.54

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cervivcal Block Before Surgery, Cervivcal Block After Surgery, Placebo Cervivcal Block Before Surgery, Placebo Cervivcal Block After Surgery
	Comments	null hypothesis: no difference in outcome measure between superficial cervical block and placebo treatment (irrespective of timing of treatment)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.016
	Comments
	Method	Non-parametric ANOVA-type statistic
	Comments	Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cervivcal Block Before Surgery, Cervivcal Block After Surgery
	Comments	null hypothesis: no difference in outcome measure pre-operative versus post-operative application
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.723
	Comments
	Method	Non-parametric ANOVA-type statistic
	Comments	Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model

3. Secondary Outcome

Title	Post-operative Pain Measured by Visual Analogue Scale
Description	Patient administered Instrument to indicate pain on a level from 0 to 10. (0: no pain, 10: worst imaginable pain)
Time Frame	24 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cervivcal Block Before Surgery	Cervivcal Block After Surgery	Placebo Cervivcal Block Before Surgery	Placebo Cervivcal Block After Surgery
Arm/Group Description	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.	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.	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.	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.
Measure Participants	41	41	38	39
Mean (Standard Deviation) [units on a scale]	1.95 (1.55)	1.51 (1.48)	2.20 (1.66)	2.06 (1.39)

4. Secondary Outcome

Title	Consumption of Post-operative Analgetics
Description	number of participants taking post-operative analgetics
Time Frame	5 days after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cervivcal Block Before Surgery	Cervivcal Block After Surgery	Placebo Cervivcal Block Before Surgery	Placebo Cervivcal Block After Surgery
Arm/Group Description	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.	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.	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.	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.
Measure Participants	41	41	38	39
paracetamol	21 51.2%	23 56.1%	18 47.4%	24 61.5%
metamizole	6 14.6%	7 17.1%	3 7.9%	7 17.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cervivcal Block Before Surgery, Cervivcal Block After Surgery, Placebo Cervivcal Block Before Surgery, Placebo Cervivcal Block After Surgery
	Comments	null hypothesis: outcome measure (Proportion of patients taking analgetics) is equal between superficial cervical block and placebo treatment (irrespective of timing) Proportion taking Paracetamol:
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.94
	Comments
	Method	Fisher Exact
	Comments	mid p value of the two-sided Fisher test

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cervivcal Block Before Surgery, Cervivcal Block After Surgery, Placebo Cervivcal Block Before Surgery, Placebo Cervivcal Block After Surgery
	Comments	null hypothesis: outcome measure (Proportion of patients taking analgetics) is equal between superficial cervical block and placebo treatment (irrespective of timing) Proportion taking Metamizole:
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.58
	Comments
	Method	Fisher Exact
	Comments	mid p value of two-sided Fisher test

5. Secondary Outcome

Title	Mean Consumption of Post-operative Analgetics
Description	mean pooled dose of post-operative analgetics
Time Frame	5 days after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cervivcal Block Before Surgery	Cervivcal Block After Surgery	Placebo Cervivcal Block Before Surgery	Placebo Cervivcal Block After Surgery
Arm/Group Description	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.	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.	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.	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.
Measure Participants	41	41	38	39
paracetamol	3.33 (2.43)	3.37 (2.43)	4.06 (3.19)	4.33 (3.56)
metamizole	1.25 (0.88)	.93 (0.61)	2.46 (2.53)	1.21 (0.64)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cervivcal Block Before Surgery, Cervivcal Block After Surgery, Placebo Cervivcal Block Before Surgery, Placebo Cervivcal Block After Surgery
	Comments	null hypothesis: no difference in pooled dose of analgetics, superficial block versus Placebo outcome: paracetamol
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.328
	Comments
	Method	Non-parametric ANOVA-type
	Comments	Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cervivcal Block Before Surgery, Cervivcal Block After Surgery, Placebo Cervivcal Block Before Surgery, Placebo Cervivcal Block After Surgery
	Comments	null hypothesis: no difference in pooled dose of analgetics, superficial block versus Placebo outcome: metamizole
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.81
	Comments
	Method	Non-parametric ANOVA-type
	Comments	Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cervivcal Block Before Surgery, Cervivcal Block After Surgery
	Comments	null hypothesis: no difference in outcome measure pre-operative and post-operative application outcome measure: pooled paracetamol dose
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.331
	Comments
	Method	Non-parametric ANOVA-type statistic
	Comments	Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cervivcal Block Before Surgery, Cervivcal Block After Surgery
	Comments	null hypothesis: no difference in outcome measure pre-operative and post-operative application outcome measure: pooled metamizole dose
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.440
	Comments
	Method	Non-parametric ANOVA-type statistic
	Comments	Non-parametric ANOVA-type statistic for pooled main effects with Box approximation, full model

6. Secondary Outcome

Title	Hospital Stay
Description	time from surgery to Hospital release in days
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cervivcal Block Before Surgery	Cervivcal Block After Surgery	Placebo Cervivcal Block Before Surgery	Placebo Cervivcal Block After Surgery
Arm/Group Description	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.	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.	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.	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.
Measure Participants	41	41	38	39
Mean (Standard Deviation) [days]	1.8 (0.7)	1.6 (0.7)	2.0 (1.1)	1.6 (0.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cervivcal Block Before Surgery, Cervivcal Block After Surgery, Placebo Cervivcal Block Before Surgery, Placebo Cervivcal Block After Surgery
	Comments	null hypothesis: no difference in outcome measure for superficial cervical block versus placebo treatment
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.925
	Comments
	Method	non-parametric ANOVA-type statistic
	Comments	non-parametric ANOVA-type statistic for pooled main effects, full model

Adverse Events

Time Frame	6 weeks after surgery
Arm/Group Title	Cervivcal Block Before Surgery		Cervivcal Block After Surgery		Placebo Cervivcal Block Before Surgery		Placebo Cervivcal Block After Surgery
Arm/Group Description	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.		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.		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.		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.
All Cause Mortality
	Cervivcal Block Before Surgery		Cervivcal Block After Surgery		Placebo Cervivcal Block Before Surgery		Placebo Cervivcal Block After Surgery
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Cervivcal Block Before Surgery		Cervivcal Block After Surgery		Placebo Cervivcal Block Before Surgery		Placebo Cervivcal Block After Surgery
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/41 (0%)		0/38 (0%)		1/39 (2.6%)
Blood and lymphatic system disorders
hemorrhage	0/41 (0%)	0	0/41 (0%)	0	0/38 (0%)	0	1/39 (2.6%)	1
Other (Not Including Serious) Adverse Events
	Cervivcal Block Before Surgery		Cervivcal Block After Surgery		Placebo Cervivcal Block Before Surgery		Placebo Cervivcal Block After Surgery
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/41 (0%)		0/38 (0%)		0/39 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.