MedTrace Logo

Ropivacaine Plus Magnesium Sulphate Infiltration

NCT05294393 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2024-07-17

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Aristotle University Of Thessaloniki

    lead OTHER

Principal Investigators

  • Styliani K Laskou · Aristotle University Of Thessaloniki

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-19
Primary Completion
2024-01-18
Completion
2024-01-18

Countries

  • Greece

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05294393 on ClinicalTrials.gov