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Ropivacaine Plus Magnesium Sulphate Infiltration

Primary Purpose

Thyroid Diseases, Parathyroid Diseases, Postoperative Pain

Status
Enrolling by invitation
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Placebo Comparator: N/S 0.9%
Ropivacaine 10%
Ropivacaine 10% plus magnesium sulphate 10mg/kg
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Thyroid Diseases focused on measuring thyroidectomy, parathyroidectomy, local wound infiltration, ropivacaine, magnesium sulphate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aristotle University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

N/S 0.9%

Ropivacaine 10%

Ropivacaine 10% magnesium sulphate 10mg/kg

Arm Description

Wound infiltration with 12 ml of N/S 0.9% at the end of surgery before wound closure

Wound infiltration with 12 ml solution of 100mg ropivacaine at the end of surgery before wound closure

Wound infiltration with 12 ml solution of 100mg ropivacaine plus magnesium sulphate 10mg/kg at the end of surgery before wound closure

Outcomes

Primary Outcome Measures

Efficacy of Ropivacaine Plus Magnesium Sulphate Infiltration vs Ropivacaine
Calculation of the total post-operative analgesic doses administered, converted to effective mg of morphine.

Secondary Outcome Measures

Incisional Pain
Incisional Pain will be measured by Visual Analogue Scale (VAS) pain questionnaire
Back of neck pain
Back of neck pain scores range 0-10.
Throat impairement
Throat pain scores will be measured by Swallowing Impairment Index (SIS)
Subjective measurements
Alterations in cortisol, Tumor Necrosis Factor a (TNF-a) and Interleukin (IL-6)
Subjective measurements 1
Alterations in cortisol in μg/dl
Subjective measurements 2
Alterations in Tumor Necrosis Factor a (TNF-a) in pg/ml
Subjective measurements 3
Alterations in Interleukin 6 (IL-6) in pg/ml
Complications
Adverse effects of the infiltrated agents

Full Information

First Posted
March 1, 2022
Last Updated
March 23, 2022
Sponsor
Aristotle University Of Thessaloniki
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1. Study Identification

Unique Protocol Identification Number
NCT05294393
Brief Title
Ropivacaine Plus Magnesium Sulphate Infiltration
Official Title
Evaluation of Ropivacaine and Ropivacaine Plus Magnesium Sulphate Infiltration for Postoperative Analgesia in Patients Undergoing Thyroidectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 21, 2022 (Actual)
Primary Completion Date
January 21, 2024 (Anticipated)
Study Completion Date
January 21, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Diseases, Parathyroid Diseases, Postoperative Pain, Anesthesia, Local
Keywords
thyroidectomy, parathyroidectomy, local wound infiltration, ropivacaine, magnesium sulphate

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Double
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
N/S 0.9%
Arm Type
Placebo Comparator
Arm Description
Wound infiltration with 12 ml of N/S 0.9% at the end of surgery before wound closure
Arm Title
Ropivacaine 10%
Arm Type
Active Comparator
Arm Description
Wound infiltration with 12 ml solution of 100mg ropivacaine at the end of surgery before wound closure
Arm Title
Ropivacaine 10% magnesium sulphate 10mg/kg
Arm Type
Experimental
Arm Description
Wound infiltration with 12 ml solution of 100mg ropivacaine plus magnesium sulphate 10mg/kg at the end of surgery before wound closure
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator: N/S 0.9%
Intervention Description
12 ml N/S 0.9% at the end of surgery
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 10%
Intervention Description
12 ml solution of 100mg ropivacaine at the end of surgery
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 10% plus magnesium sulphate 10mg/kg
Intervention Description
12 ml solution of 100mg ropivacaine plus magnesium sulphate 10mg/kg at the end of surgery
Primary Outcome Measure Information:
Title
Efficacy of Ropivacaine Plus Magnesium Sulphate Infiltration vs Ropivacaine
Description
Calculation of the total post-operative analgesic doses administered, converted to effective mg of morphine.
Time Frame
24 postoperative hours
Secondary Outcome Measure Information:
Title
Incisional Pain
Description
Incisional Pain will be measured by Visual Analogue Scale (VAS) pain questionnaire
Time Frame
30 minutes ,1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours
Title
Back of neck pain
Description
Back of neck pain scores range 0-10.
Time Frame
30 minutes ,1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours
Title
Throat impairement
Description
Throat pain scores will be measured by Swallowing Impairment Index (SIS)
Time Frame
30 minutes ,1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours
Title
Subjective measurements
Description
Alterations in cortisol, Tumor Necrosis Factor a (TNF-a) and Interleukin (IL-6)
Time Frame
30 minutes before the infiltration, 6 hours and 24 hours postoperatively
Title
Subjective measurements 1
Description
Alterations in cortisol in μg/dl
Time Frame
30 minutes before the infiltration, 6 hours and 24 hours postoperatively
Title
Subjective measurements 2
Description
Alterations in Tumor Necrosis Factor a (TNF-a) in pg/ml
Time Frame
30 minutes before the infiltration, 6 hours and 24 hours postoperatively
Title
Subjective measurements 3
Description
Alterations in Interleukin 6 (IL-6) in pg/ml
Time Frame
30 minutes before the infiltration, 6 hours and 24 hours postoperatively
Title
Complications
Description
Adverse effects of the infiltrated agents
Time Frame
24 hours, 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Styliani K Laskou
Organizational Affiliation
Aristotle University Of Thessaloniki
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aristotle University
City
Thessaloniki
State/Province
Other
ZIP/Postal Code
54636
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No

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Ropivacaine Plus Magnesium Sulphate Infiltration

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