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Ropivacaine Plus Magnesium Sulphate Infiltration

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

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

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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

Resource links provided by the National Library of Medicine


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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05294393


Locations
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Greece
Aristotle University
Thessaloniki, Other, Greece, 54636
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Investigators
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Principal Investigator: Styliani K Laskou Aristotle University Of Thessaloniki
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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    Key Record Dates
Last Update Posted: March 24, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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