Ropivacaine Plus Magnesium Sulphate Infiltration

Sponsor

Aristotle University Of Thessaloniki (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05294393

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Jan 21, 2022

Anticipated Primary Completion Date :

Jan 21, 2024

Anticipated Study Completion Date :

Jan 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

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

Efficacy of Ropivacaine Plus Magnesium Sulphate Infiltration vs Ropivacaine [24 postoperative hours]
Calculation of the total post-operative analgesic doses administered, converted to effective mg of morphine.

Secondary Outcome Measures

Incisional Pain [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
Back of neck pain [30 minutes ,1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours]
Back of neck pain scores range 0-10.
Throat impairement [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)
Subjective measurements [30 minutes before the infiltration, 6 hours and 24 hours postoperatively]
Alterations in cortisol, Tumor Necrosis Factor a (TNF-a) and Interleukin (IL-6)
Subjective measurements 1 [30 minutes before the infiltration, 6 hours and 24 hours postoperatively]
Alterations in cortisol in μg/dl
Subjective measurements 2 [30 minutes before the infiltration, 6 hours and 24 hours postoperatively]
Alterations in Tumor Necrosis Factor a (TNF-a) in pg/ml
Subjective measurements 3 [30 minutes before the infiltration, 6 hours and 24 hours postoperatively]
Alterations in Interleukin 6 (IL-6) in pg/ml
Complications [24 hours, 7 days]
Adverse effects of the infiltrated agents