Aristotle University
Thessaloniki, Other, 54636, Greece
NCT Number: NCT05294393
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Thessaloniki, Other, 54636, Greece
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
12 ml N/S 0.9% at the end of surgery
12 ml solution of 100mg ropivacaine at the end of surgery
12 ml solution of 100mg ropivacaine plus magnesium sulphate 10mg/kg at the end of surgery
Time frame: 24 postoperative hours
Calculation of the total post-operative analgesic doses administered, converted to effective mg of morphine.
Time frame: 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
Time frame: 30 minutes before the infiltration, 6 hours and 24 hours postoperatively
Alterations in cortisol in μg/dl
Time frame: 30 minutes before the infiltration, 6 hours and 24 hours postoperatively
Alterations in Tumor Necrosis Factor a (TNF-a) in pg/ml
Time frame: 30 minutes before the infiltration, 6 hours and 24 hours postoperatively
Alterations in Interleukin 6 (IL-6) in pg/ml
Time frame: 24 hours, 7 days
Adverse effects of the infiltrated agents
Aristotle University Of Thessaloniki
Other
Evaluation of Ropivacaine and Ropivacaine Plus Magnesium Sulphate Infiltration for Postoperative Analgesia in Patients Undergoing Thyroidectomy
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