Anesthesia, Local, Parathyroid Diseases, Postoperative Pain, Thyroid Diseases
Conditions
Keywords
thyroidectomy, parathyroidectomy, local wound infiltration, ropivacaine, magnesium sulphate
Brief summary
In the domain of endocrine gland surgery, thyroidectomy is the most common procedure. Patients report moderate to severe discomfort postoperatively, which is induced by a variety of mechanisms, the most common of which are cervical incision and surgical maneuvers. The other two causes are endotracheal intubation and neck overextension. Incisional pain, odynophagia, dysphagia, neck and shoulder pain have all been reported as sources of discomfort.However, it seems that this discomfort has a time limit, with a considerable decrease in pain scores that will last 24 to 36 hours. Pain is felt more profoundly within the first few hours after surgery, peaking at 6 hours, with patients requesting further analgesic medication. Surgical wound infiltration can inhibit this procedure by preventing the alginate signal from reaching the incision site's receptors. According to the multimodal analgesia trends, magnesium sulfate can be added to the ropivacaine solution. Magnesium acts as an NMDA (N-methyl-D-aspartate) receptor antagonist, inhibiting cerebral sensitization to peripheral pain stimuli while reducing pre-existing hyperalgesia. It becomes evident that this combination could contribute to attain the maximum analgesic efficacy. So, if any superiority of ropivacaine plus magnesium sulphate over ropivacaine could be demonstrated this would be very helpful in providing sufficient analgesic effects with a low incidence of adverse effects, while enhancing the option of one day surgery.
Interventions
DRUGPlacebo Comparator: N/S 0.9%
12 ml N/S 0.9% at the end of surgery
DRUGRopivacaine 10%
12 ml solution of 100mg ropivacaine at the end of surgery
DRUGRopivacaine 10% plus magnesium sulphate 10mg/kg
12 ml solution of 100mg ropivacaine plus magnesium sulphate 10mg/kg at the end of surgery
Sponsors
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patient ≥ 18 years old * Surgical indication for Total thyroidectomy * Surgical indication forparathyroidectomy
Exclusion criteria
* Patients \< 18 years old * Prior neck operation * Lateral neck dissection * Patient with history of chronic opioid use * Patient with chronic pain syndromes * Patient with allergy to ropivacaine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Ropivacaine Plus Magnesium Sulphate Infiltration vs Ropivacaine | 24 postoperative hours | Calculation of the total post-operative analgesic doses administered, converted to effective mg of morphine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incisional Pain | 30 minutes ,1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours | Incisional Pain will be measured by Visual Analogue Scale (VAS) pain questionnaire |
| Subjective measurements 1 | 30 minutes before the infiltration, 6 hours and 24 hours postoperatively | Alterations in cortisol in μg/dl |
| Subjective measurements 2 | 30 minutes before the infiltration, 6 hours and 24 hours postoperatively | Alterations in Tumor Necrosis Factor a (TNF-a) in pg/ml |
| Subjective measurements 3 | 30 minutes before the infiltration, 6 hours and 24 hours postoperatively | Alterations in Interleukin 6 (IL-6) in pg/ml |
| Complications | 24 hours, 7 days | Adverse effects of the infiltrated agents |
Countries
Greece
Outcome results
None listed