Ropivacaine Plus Magnesium Sulphate Infiltration

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05294393
• Other study ID #: 3.468
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: January 21, 2022
• Est. completion date: January 21, 2024

Study information

• Verified date: March 2022
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 64
• Est. completion date: January 21, 2024
• Est. primary completion date: January 21, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Placebo Comparator: N/S 0.9%
12 ml N/S 0.9% at the end of surgery
• Ropivacaine 10%
12 ml solution of 100mg ropivacaine at the end of surgery
• Ropivacaine 10% plus magnesium sulphate 10mg/kg
12 ml solution of 100mg ropivacaine plus magnesium sulphate 10mg/kg at the end of surgery

Locations

Country	Name	City	State
Greece	Aristotle University	Thessaloniki	Other

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Back of neck pain	Back of neck pain scores range 0-10.	30 minutes ,1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours
Secondary	Throat impairement	Throat pain scores will be measured by Swallowing Impairment Index (SIS)	30 minutes ,1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours
Secondary	Subjective measurements	Alterations in cortisol, Tumor Necrosis Factor a (TNF-a) and Interleukin (IL-6)	30 minutes before the infiltration, 6 hours and 24 hours postoperatively
Secondary	Subjective measurements 1	Alterations in cortisol in µg/dl	30 minutes before the infiltration, 6 hours and 24 hours postoperatively
Secondary	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
Secondary	Subjective measurements 3	Alterations in Interleukin 6 (IL-6) in pg/ml	30 minutes before the infiltration, 6 hours and 24 hours postoperatively
Secondary	Complications	Adverse effects of the infiltrated agents	24 hours, 7 days