Ropivacaine Plus Magnesium Sulphate Infiltration

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Ropivacaine and Ropivacaine Plus Magnesium Sulphate Infiltration for Postoperative Analgesia in Patients Undergoing Thyroidectomy

Conditions
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Thyroid Diseases, Parathyroid Diseases, Postoperative Pain, Anesthesia, Local

Intervention / Treatment
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* Drug: Placebo Comparator: N/S 0.9%
* Drug: Ropivacaine 10%
* Drug: Ropivacaine 10% plus magnesium sulphate 10mg/kg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: N/S 0.9%<br>Wound infiltration with 12 ml of N/S 0.9% at the end of surgery before wound closure | Drug: Placebo Comparator: N/S 0.9%<br>* 12 ml N/S 0.9% at the end of surgery<br>|
| Active Comparator: Ropivacaine 10%<br>Wound infiltration with 12 ml solution of 100mg ropivacaine at the end of surgery before wound closure | Drug: Ropivacaine 10%<br>* 12 ml solution of 100mg ropivacaine at the end of surgery<br>|
| Experimental: Ropivacaine 10% magnesium sulphate 10mg/kg<br>Wound infiltration with 12 ml solution of 100mg ropivacaine plus magnesium sulphate 10mg/kg at the end of surgery before wound closure | Drug: Ropivacaine 10% plus magnesium sulphate 10mg/kg<br>* 12 ml solution of 100mg ropivacaine plus magnesium sulphate 10mg/kg at the end of surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Ropivacaine Plus Magnesium Sulphate Infiltration vs Ropivacaine | Calculation of the total post-operative analgesic doses administered, converted to effective mg of morphine. | 24 postoperative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incisional Pain | Incisional Pain will be measured by Visual Analogue Scale (VAS) pain questionnaire | 30 minutes ,1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours | 
| Back of neck pain | Back of neck pain scores range 0-10. | 30 minutes ,1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours | 
| Throat impairement | Throat pain scores will be measured by Swallowing Impairment Index (SIS) | 30 minutes ,1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours | 
| Subjective measurements | Alterations in cortisol, Tumor Necrosis Factor a (TNF-a) and Interleukin (IL-6) | 30 minutes before the infiltration, 6 hours and 24 hours postoperatively | 
| Subjective measurements 1 | Alterations in cortisol in μg/dl | 30 minutes before the infiltration, 6 hours and 24 hours postoperatively | 
| Subjective measurements 2 | Alterations in Tumor Necrosis Factor a (TNF-a) in pg/ml | 30 minutes before the infiltration, 6 hours and 24 hours postoperatively | 
| Subjective measurements 3 | Alterations in Interleukin 6 (IL-6) in pg/ml | 30 minutes before the infiltration, 6 hours and 24 hours postoperatively | 
| Complications | Adverse effects of the infiltrated agents | 24 hours, 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thyroidectomy, parathyroidectomy, local wound infiltration, ropivacaine, magnesium sulphate