Thyroidectomy
Conditions
Keywords
Surgery, Thyroid gland, cervical block, Pain, Postoperative
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.
Interventions
DRUGbilateral 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.
DRUGplacebo 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.
Sponsors
Cantonal Hospital of St. Gallen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Consumption of Post-operative Analgetics | 5 days after surgery | number of participants taking post-operative analgetics |
| Mean Consumption of Post-operative Analgetics | 5 days after surgery | mean pooled dose of post-operative analgetics |
| Hospital Stay | 90 days | time from surgery to Hospital release in days |
Countries
Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 41 |
| 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. | 41 |
| 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. | 38 |
| 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. | 39 |
| Total | 159 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 |
| Overall Study | Questionnaires not returned | 5 | 6 | 6 | 4 |
| Overall Study | Reintervention | 0 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Cervivcal Block Before Surgery | Cervivcal Block After Surgery | Placebo Cervivcal Block Before Surgery | Placebo Cervivcal Block After Surgery | Total |
|---|---|---|---|---|---|
| Age, Continuous | 49.1 years STANDARD_DEVIATION 14 | 46.5 years STANDARD_DEVIATION 13.3 | 49.9 years STANDARD_DEVIATION 13.5 | 47.3 years STANDARD_DEVIATION 14.4 | 48.2 years STANDARD_DEVIATION 13.7 |
| duration of surgery | 140.8 minutes STANDARD_DEVIATION 48.1 | 130.5 minutes STANDARD_DEVIATION 37 | 129.6 minutes STANDARD_DEVIATION 48.1 | 141.9 minutes STANDARD_DEVIATION 50.4 | 135.7 minutes STANDARD_DEVIATION 45.7 |
| Region of Enrollment Switzerland | 41 participants | 41 participants | 38 participants | 39 participants | 159 participants |
| resection location bilateral | 23 participants | 19 participants | 14 participants | 13 participants | 69 participants |
| resection location unilateral | 18 participants | 22 participants | 24 participants | 26 participants | 90 participants |
| Sex: Female, Male Female | 33 Participants | 36 Participants | 29 Participants | 31 Participants | 129 Participants |
| Sex: Female, Male Male | 8 Participants | 5 Participants | 9 Participants | 8 Participants | 30 Participants |
| specimen weight | 60.4 gram STANDARD_DEVIATION 55.1 | 42.2 gram STANDARD_DEVIATION 32 | 51.0 gram STANDARD_DEVIATION 43.6 | 39.8 gram STANDARD_DEVIATION 41.2 | 47.0 gram STANDARD_DEVIATION 43.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 41 | 0 / 41 | 0 / 38 | 0 / 39 |
| serious Total, serious adverse events | 0 / 41 | 0 / 41 | 0 / 38 | 1 / 39 |
Outcome results
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)
Time frame: 4 days after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervivcal Block Before Surgery | Pooled Relative Treatment Effect of VAS | 0.47 pooled relative treatment effect |
| Cervivcal Block After Surgery | Pooled Relative Treatment Effect of VAS | 0.45 pooled relative treatment effect |
| Placebo Cervivcal Block Before Surgery | Pooled Relative Treatment Effect of VAS | 0.55 pooled relative treatment effect |
| Placebo Cervivcal Block After Surgery | Pooled Relative Treatment Effect of VAS | 0.54 pooled relative treatment effect |
Comparison: null hypothesis: no difference in outcome measure between superficial cervical block and placebo treatment (irrespective of timing of treatment)p-value: 0.016Non-parametric ANOVA-type statistic
Comparison: null hypothesis: no difference in outcome measure pre-operative versus post-operative applicationp-value: 0.723Non-parametric ANOVA-type statistic
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)
Time frame: 6 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cervivcal Block Before Surgery | Post-operative Pain Measured by Visual Analogue Scale | 2.15 units on a scale | Standard Deviation 2.17 |
| Cervivcal Block After Surgery | Post-operative Pain Measured by Visual Analogue Scale | 2.02 units on a scale | Standard Deviation 2.06 |
| Placebo Cervivcal Block Before Surgery | Post-operative Pain Measured by Visual Analogue Scale | 2.84 units on a scale | Standard Deviation 1.75 |
| Placebo Cervivcal Block After Surgery | Post-operative Pain Measured by Visual Analogue Scale | 2.72 units on a scale | Standard Deviation 1.89 |
Comparison: null hypothesis: no difference in outcome measure between superficial cervical block and placebo treatment (irrespective of timing of treatment)p-value: 0.028t-test, 2 sided
Secondary
Consumption of Post-operative Analgetics
number of participants taking post-operative analgetics
Time frame: 5 days after surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervivcal Block Before Surgery | Consumption of Post-operative Analgetics | paracetamol | 21 participants |
| Cervivcal Block Before Surgery | Consumption of Post-operative Analgetics | metamizole | 6 participants |
| Cervivcal Block After Surgery | Consumption of Post-operative Analgetics | metamizole | 7 participants |
| Cervivcal Block After Surgery | Consumption of Post-operative Analgetics | paracetamol | 23 participants |
| Placebo Cervivcal Block Before Surgery | Consumption of Post-operative Analgetics | paracetamol | 18 participants |
| Placebo Cervivcal Block Before Surgery | Consumption of Post-operative Analgetics | metamizole | 3 participants |
| Placebo Cervivcal Block After Surgery | Consumption of Post-operative Analgetics | paracetamol | 24 participants |
| Placebo Cervivcal Block After Surgery | Consumption of Post-operative Analgetics | metamizole | 7 participants |
Comparison: null hypothesis: outcome measure (Proportion of patients taking analgetics) is equal between superficial cervical block and placebo treatment (irrespective of timing)~Proportion taking Paracetamol:p-value: 0.94Fisher Exact
Comparison: null hypothesis: outcome measure (Proportion of patients taking analgetics) is equal between superficial cervical block and placebo treatment (irrespective of timing)~Proportion taking Metamizole:p-value: 0.58Fisher Exact
Secondary
Hospital Stay
time from surgery to Hospital release in days
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cervivcal Block Before Surgery | Hospital Stay | 1.8 days | Standard Deviation 0.7 |
| Cervivcal Block After Surgery | Hospital Stay | 1.6 days | Standard Deviation 0.7 |
| Placebo Cervivcal Block Before Surgery | Hospital Stay | 2.0 days | Standard Deviation 1.1 |
| Placebo Cervivcal Block After Surgery | Hospital Stay | 1.6 days | Standard Deviation 0.6 |
Comparison: null hypothesis: no difference in outcome measure for superficial cervical block versus placebo treatmentp-value: 0.925non-parametric ANOVA-type statistic
Secondary
Mean Consumption of Post-operative Analgetics
mean pooled dose of post-operative analgetics
Time frame: 5 days after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cervivcal Block Before Surgery | Mean Consumption of Post-operative Analgetics | paracetamol | 3.33 gram | Standard Deviation 2.43 |
| Cervivcal Block Before Surgery | Mean Consumption of Post-operative Analgetics | metamizole | 1.25 gram | Standard Deviation 0.88 |
| Cervivcal Block After Surgery | Mean Consumption of Post-operative Analgetics | paracetamol | 3.37 gram | Standard Deviation 2.43 |
| Cervivcal Block After Surgery | Mean Consumption of Post-operative Analgetics | metamizole | .93 gram | Standard Deviation 0.61 |
| Placebo Cervivcal Block Before Surgery | Mean Consumption of Post-operative Analgetics | metamizole | 2.46 gram | Standard Deviation 2.53 |
| Placebo Cervivcal Block Before Surgery | Mean Consumption of Post-operative Analgetics | paracetamol | 4.06 gram | Standard Deviation 3.19 |
| Placebo Cervivcal Block After Surgery | Mean Consumption of Post-operative Analgetics | metamizole | 1.21 gram | Standard Deviation 0.64 |
| Placebo Cervivcal Block After Surgery | Mean Consumption of Post-operative Analgetics | paracetamol | 4.33 gram | Standard Deviation 3.56 |
Comparison: null hypothesis: no difference in pooled dose of analgetics, superficial block versus Placebo~outcome: paracetamolp-value: 0.328Non-parametric ANOVA-type
Comparison: null hypothesis: no difference in pooled dose of analgetics, superficial block versus Placebo~outcome: metamizolep-value: 0.81Non-parametric ANOVA-type
Comparison: null hypothesis: no difference in outcome measure pre-operative and post-operative application~outcome measure: pooled paracetamol dosep-value: 0.331Non-parametric ANOVA-type statistic
Comparison: null hypothesis: no difference in outcome measure pre-operative and post-operative application~outcome measure: pooled metamizole dosep-value: 0.44Non-parametric ANOVA-type statistic
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)
Time frame: 24 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cervivcal Block Before Surgery | Post-operative Pain Measured by Visual Analogue Scale | 1.95 units on a scale | Standard Deviation 1.55 |
| Cervivcal Block After Surgery | Post-operative Pain Measured by Visual Analogue Scale | 1.51 units on a scale | Standard Deviation 1.48 |
| Placebo Cervivcal Block Before Surgery | Post-operative Pain Measured by Visual Analogue Scale | 2.20 units on a scale | Standard Deviation 1.66 |
| Placebo Cervivcal Block After Surgery | Post-operative Pain Measured by Visual Analogue Scale | 2.06 units on a scale | Standard Deviation 1.39 |