Ropivacaine Plus Magnesium Sulphate Infiltration

Aristotle University Of Thessaloniki

Status and phase: Completed; Phase 4

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

Treatments: Drug: Ropivacaine 10% plus magnesium sulphate 10mg/kg; Drug: Placebo Comparator: N/S 0.9%; Drug: Ropivacaine 10%

Study type: Interventional

Funder types: Other

Identifiers

NCT05294393

3.468

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 3 patient groups, including a placebo group

N/S 0.9%

Placebo Comparator group

Description:

Wound infiltration with 12 ml of N/S 0.9% at the end of surgery before wound closure

Treatment:

Drug: Placebo Comparator: N/S 0.9%

Ropivacaine 10%

Active Comparator group

Description:

Wound infiltration with 12 ml solution of 100mg ropivacaine at the end of surgery before wound closure

Treatment:

Drug: Ropivacaine 10%

Ropivacaine 10% magnesium sulphate 10mg/kg

Experimental group

Description:

Wound infiltration with 12 ml solution of 100mg ropivacaine plus magnesium sulphate 10mg/kg at the end of surgery before wound closure

Treatment:

Drug: Ropivacaine 10% plus magnesium sulphate 10mg/kg