Ropivacaine Plus Magnesium Sulphate Infiltration

NCT05294393 | Completed Phase 4

• 1 other identifier: 3.468
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Diseases; Parathyroid Diseases; Postoperative Pain; Anesthesia, Local

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Incisional Pain

  30 minutes ,1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours

• Subjective measurements 1

  30 minutes before the infiltration, 6 hours and 24 hours postoperatively

• Subjective measurements 2

  30 minutes before the infiltration, 6 hours and 24 hours postoperatively

• Subjective measurements 3

  30 minutes before the infiltration, 6 hours and 24 hours postoperatively

• Complications

  24 hours, 7 days

Study Arms (3)

N/S 0.9%

PLACEBO COMPARATOR

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%

Ropivacaine 10%

ACTIVE COMPARATOR

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

Drug: Ropivacaine 10%

Ropivacaine 10% magnesium sulphate 10mg/kg

EXPERIMENTAL

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

Interventions

Placebo Comparator: N/S 0.9% DRUG

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

N/S 0.9%

Ropivacaine 10% DRUG

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

Ropivacaine 10%

Ropivacaine 10% plus magnesium sulphate 10mg/kg DRUG

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

Ropivacaine 10% magnesium sulphate 10mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient ≥ 18 years old
• Surgical indication for Total thyroidectomy
• Surgical indication forparathyroidectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Aristotle University

Thessaloniki, Other, 54636, Greece

Location

MeSH Terms

Conditions

Thyroid Diseases; Parathyroid Diseases; Pain, Postoperative

Interventions

Ropivacaine; Magnesium Sulfate

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Styliani K Laskou

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 24, 2022
• Study Start: January 19, 2022
• Primary Completion: January 18, 2024
• Study Completion: January 18, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)