Ropivacaine Plus Magnesium Sulphate Infiltration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-19

Study Completion Date

2024-01-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Thyroid Diseases Parathyroid Diseases Postoperative Pain Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Double

Study Groups

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N/S 0.9%

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

Group Type PLACEBO_COMPARATOR

Placebo Comparator: N/S 0.9%

Intervention Type DRUG

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

Ropivacaine 10%

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

Group Type ACTIVE_COMPARATOR

Ropivacaine 10%

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Ropivacaine 10% plus magnesium sulphate 10mg/kg

Intervention Type DRUG

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

Interventions

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Placebo Comparator: N/S 0.9%

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

Intervention Type DRUG

Ropivacaine 10%

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

Intervention Type DRUG

Ropivacaine 10% plus magnesium sulphate 10mg/kg

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes