Clinical trial NCT05294393: Ropivacaine Plus Magnesium Sulphate Infiltration
Official title: Evaluation of Ropivacaine and Ropivacaine Plus Magnesium Sulphate Infiltration for Postoperative Analgesia in Patients Undergoing Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thyroid Diseases
Parathyroid Diseases
Postoperative Pain
Anesthesia, Local
Keywords: thyroidectomy
parathyroidectomy
local wound infiltration
ropivacaine
magnesium sulphate
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of Ropivacaine Plus Magnesium Sulphate Infiltration vs Ropivacaine
timeFrame: 24 postoperative hours
Secondary outcomes:
measure: Incisional Pain
timeFrame: 30 minutes ,1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours
measure: Subjective measurements 1
timeFrame: 30 minutes before the infiltration, 6 hours and 24 hours postoperatively
measure: Subjective measurements 2
timeFrame: 30 minutes before the infiltration, 6 hours and 24 hours postoperatively
measure: Subjective measurements 3
timeFrame: 30 minutes before the infiltration, 6 hours and 24 hours postoperatively
measure: Complications
timeFrame: 24 hours, 7 days
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Aristotle University
state: Other
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Styliani K Laskou
role: PRINCIPAL_INVESTIGATOR
References: