Ropivacaine Plus Magnesium Sulphate Infiltration

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

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.

Study Overview

• Status: Completed
• Conditions: Parathyroid Diseases; Thyroid Diseases; Postoperative Pain; Anesthesia, Local
• Intervention / Treatment: Drug: Placebo Comparator: N/S 0.9%; Drug: Ropivacaine 10%; Drug: Ropivacaine 10% plus magnesium sulphate 10mg/kg

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 4

Contacts and Locations

Study Locations

• Greece
  • Other
    • Thessaloniki, Other, Greece, 54636
      • Aristotle University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: N/S 0.9%; Wound infiltration with 12 ml of N/S 0.9% at the end of surgery before wound closure	Drug: Placebo Comparator: N/S 0.9%; 12 ml N/S 0.9% at the end of surgery
Active Comparator: Ropivacaine 10%; Wound infiltration with 12 ml solution of 100mg ropivacaine at the end of surgery before wound closure	Drug: Ropivacaine 10%; 12 ml solution of 100mg ropivacaine at the end of surgery
Experimental: Ropivacaine 10% magnesium sulphate 10mg/kg; Wound infiltration with 12 ml solution of 100mg ropivacaine plus magnesium sulphate 10mg/kg at the end of surgery before wound closure	Drug: Ropivacaine 10% plus magnesium sulphate 10mg/kg; 12 ml solution of 100mg ropivacaine plus magnesium sulphate 10mg/kg at the end of surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Ropivacaine Plus Magnesium Sulphate Infiltration vs Ropivacaine	Calculation of the total post-operative analgesic doses administered, converted to effective mg of morphine.	24 postoperative hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incisional Pain	Incisional Pain will be measured by Visual Analogue Scale (VAS) pain questionnaire	30 minutes ,1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours
Subjective measurements 1	Alterations in cortisol in μg/dl	30 minutes before the infiltration, 6 hours and 24 hours postoperatively
Subjective measurements 2	Alterations in Tumor Necrosis Factor a (TNF-a) in pg/ml	30 minutes before the infiltration, 6 hours and 24 hours postoperatively
Subjective measurements 3	Alterations in Interleukin 6 (IL-6) in pg/ml	30 minutes before the infiltration, 6 hours and 24 hours postoperatively
Complications	Adverse effects of the infiltrated agents	24 hours, 7 days

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Investigators: Principal Investigator: Styliani K Laskou, Aristotle University of Thessaloniki

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2022
• Primary Completion (Actual): January 18, 2024
• Study Completion (Actual): January 18, 2024

Study Registration Dates

• First Submitted: March 1, 2022
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: ropivacaine; thyroidectomy; magnesium sulphate; parathyroidectomy; local wound infiltration
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Parathyroid Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Anesthetics, Local; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Ropivacaine; Magnesium Sulfate
• Other Study ID Numbers: 3.468

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No