Ropivacaine Plus Magnesium Sulphate Infiltration

• ClinicalTrials.gov Identifier: NCT05294393
• Recruitment Status: Enrolling by invitation
• First Posted: March 24, 2022
• Last Update Posted: March 24, 2022
• Sponsor: Aristotle University Of Thessaloniki
• Information provided by (Responsible Party): Styliani Konstantinos Laskou, Aristotle University Of Thessaloniki

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Thyroid Diseases; Parathyroid Diseases; Postoperative Pain; Anesthesia, Local	Drug: Placebo Comparator: N/S 0.9%; Drug: Ropivacaine 10%; Drug: Ropivacaine 10% plus magnesium sulphate 10mg/kg	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Double
• Primary Purpose: Supportive Care
• Official Title: Evaluation of Ropivacaine and Ropivacaine Plus Magnesium Sulphate Infiltration for Postoperative Analgesia in Patients Undergoing Thyroidectomy
• Actual Study Start Date: January 21, 2022
• Estimated Primary Completion Date: January 21, 2024
• Estimated Study Completion Date: January 21, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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. Back of neck pain [ Time Frame: 30 minutes ,1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours ]
   Back of neck pain scores range 0-10.
3. Throat impairement [ Time Frame: 30 minutes ,1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours ]
   Throat pain scores will be measured by Swallowing Impairment Index (SIS)
4. Subjective measurements [ Time Frame: 30 minutes before the infiltration, 6 hours and 24 hours postoperatively ]
   Alterations in cortisol, Tumor Necrosis Factor a (TNF-a) and Interleukin (IL-6)
5. Subjective measurements 1 [ Time Frame: 30 minutes before the infiltration, 6 hours and 24 hours postoperatively ]
   Alterations in cortisol in μg/dl
6. 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
7. 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
8. Complications [ Time Frame: 24 hours, 7 days ]
   Adverse effects of the infiltrated agents

Eligibility Criteria

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

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

Contacts and Locations

Locations

Greece

Aristotle University

Thessaloniki, Other, Greece, 54636

Sponsors and Collaborators

Aristotle University Of Thessaloniki

Investigators

• Principal Investigator: Styliani K Laskou; Aristotle University Of Thessaloniki

More Information

• Responsible Party: Styliani Konstantinos Laskou, Principal Investigator, Aristotle University Of Thessaloniki
• ClinicalTrials.gov Identifier: NCT05294393
• Other Study ID Numbers: 3.468
• First Posted: March 24, 2022
• Last Update Posted: March 24, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Styliani Konstantinos Laskou, Aristotle University Of Thessaloniki:

thyroidectomy; parathyroidectomy; local wound infiltration; ropivacaine; magnesium sulphate

Additional relevant MeSH terms:

Thyroid Diseases; Parathyroid Diseases; Endocrine System Diseases; Magnesium Sulfate; Ropivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Analgesics; Anti-Arrhythmia Agents; Anticonvulsants; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Tocolytic Agents; Reproductive Control Agents