RecruitingACTRN12617001320347

Magnesium in open shoulder surgery

Effect of Intravenous Magnesium on Post-operative Pain following Open Shoulder Surgery

Sponsor

Melbourne Orthopaedic Group

Enrollment

50 participants

Start Date

Apr 25, 2017

Study Type

Interventional

Conditions

Open Shoulder Surgery

Summary

Many patients who require surgery on the shoulder experience significant post operative pain, particularly after their nerve block wears off. Despite the use of conventional analgesia many patients remain uncomfortable during this period. The aim of this project is to determine whether giving magnesium prior to surgery can improve this pain experience. The study proposes to give a single dose of magnesium to patients immediately prior to surgery and to assess their level of pain after surgery. This will involve the use of a subjective pain rating scale (1-10), and documentation of analgesic requirement. Patients will be randomly selected to receive either magnesium or placebo saline solution in order to assess the benefits of magnesium. Magnesium itself is a safe drug commonly used in clinical medicine for a number of different conditions.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether giving a single dose of magnesium through an IV drip before shoulder surgery can reduce pain after the operation — especially after a nerve block has worn off. Shoulder surgery often causes significant post-operative pain, and standard pain relief does not always work well. Magnesium is a safe, widely used medication that may help block pain signals. Patients are randomly assigned to receive either magnesium or a saltwater placebo, and their pain levels and pain medication use are tracked after surgery. You may be eligible if: - You are 18 to 75 years old - You are scheduled for planned (elective) open shoulder surgery You may NOT be eligible if: - You have a chronic pain syndrome - You have a heart conduction defect or a pacemaker - You are unable to communicate your pain level due to a language barrier or comprehension difficulty Talk to your doctor about whether this trial might be right for you.

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Interventions

Patients will be administered 50mg/kg of intravenous Magnesium Sulphate at a rate of less than 8g/hr immediately prior to surgery while monitored in the holding bay. This will take place over 30-60 minutes at the anaesthetists discretion. Magnesium sulphate infusion is an established therapy often used in intensive care and the obstetric patient suffering pre-eclampsia. Experience has shown it has a very safe side effect profile. Normal dosage given for previously mentioned indications is 40-50mg/kg. The recommended rate of administration is no greater than 8g per hour. Our regimen is in accordance with these guidelines.

Locations(1)

The Avenue Private Hospital - Windsor

VIC, Australia

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ACTRN12617001320347