NCT05294393

Ropivacaine Plus Magnesium Sulphate Infiltration

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Aristotle University Of Thessaloniki · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Placebo Comparator: N/S 0.9%	12 ml N/S 0.9% at the end of surgery
DRUG	Ropivacaine 10%	12 ml solution of 100mg ropivacaine at the end of surgery
DRUG	Ropivacaine 10% plus magnesium sulphate 10mg/kg	12 ml solution of 100mg ropivacaine plus magnesium sulphate 10mg/kg at the end of surgery

Timeline

• Start date: 2022-01-19
• Primary completion: 2024-01-18
• Completion: 2024-01-18
• First posted: 2022-03-24
• Last updated: 2024-07-17

Locations

1 site across 1 country: Greece