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Completed

NCT Number: NCT05294393

Ropivacaine Plus Magnesium Sulphate Infiltration

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aristotle University

Thessaloniki, Other, 54636, Greece

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo Comparator: N/S 0.9%

Drug

12 ml N/S 0.9% at the end of surgery

Ropivacaine 10%

Drug

12 ml solution of 100mg ropivacaine at the end of surgery

Ropivacaine 10% plus magnesium sulphate 10mg/kg

Drug

12 ml solution of 100mg ropivacaine plus magnesium sulphate 10mg/kg at the end of surgery

Primary outcomes

  1. Efficacy of Ropivacaine Plus Magnesium Sulphate Infiltration vs Ropivacaine

    Time frame: 24 postoperative hours

    Calculation of the total post-operative analgesic doses administered, converted to effective mg of morphine.

Secondary outcomes

  1. Incisional Pain

    Time frame: 30 minutes ,1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours

    Incisional Pain will be measured by Visual Analogue Scale (VAS) pain questionnaire

  2. Subjective measurements 1

    Time frame: 30 minutes before the infiltration, 6 hours and 24 hours postoperatively

    Alterations in cortisol in μg/dl

  3. Subjective measurements 2

    Time frame: 30 minutes before the infiltration, 6 hours and 24 hours postoperatively

    Alterations in Tumor Necrosis Factor a (TNF-a) in pg/ml

  4. Subjective measurements 3

    Time frame: 30 minutes before the infiltration, 6 hours and 24 hours postoperatively

    Alterations in Interleukin 6 (IL-6) in pg/ml

  5. Complications

    Time frame: 24 hours, 7 days

    Adverse effects of the infiltrated agents

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 24, 2022
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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