Magnesium as an Adjunct for Pain Treatment After Surgery for Thumb Base Arthrosis

Study Overview
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Brief Summary
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A randomised controlled trial of addition to the standard pain treatment of 1000 mg oral magnesium citrate or placebo for 7 Days during surgery for thumb base arthrosis. Intraoperative nociception will be measured with the NoL-index with a PM-200 machine.

Detailed Description
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Our hypothesis is that an addition of oral 1000 mg magnesium citrate daily for 7 Days starting at the day of the surgery will decrease the postoperative pain and improve the recovery after surgery. It will be given as an supplement to the regular pain treatment with acetaminophen and oxycodone that are used in our hospital and compared to a placebo. The choice of treatment will be blinded for the patient, the care providers and for the research team doing the evaluation. The pain level will be collected Before surgery, postoperatively and at 14 Days after surgery and by a self reporting form during the first 7 Days. The patients will also report their recovery with a modified QoR-15 form. QoR-15 is validated in a Swedish version. Magnesium is shown to reduce postoperative pain in some studies that used iv magnesium sulphate. For long lasting pain conditions oral magnesium is shown to improve the patients well being and decrease their pain in some conditions. Magnesium acts as a mild antagonist at the NMDA-receptor. Thus low levels of magnesium is thought to increase the risk of long lasting postoperative pain. Therefore there are reason to expect a higher dose of magnesium supplement decreases the long lasting post operative pain.

Official Title
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Magnesium as an Adjunct for Pain Treatment After Surgery for Thumb Base Arthrosis, a Randomised Controlled Study

Conditions
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Thumb Osteoarthritis

Intervention / Treatment
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* Dietary Supplement: magnesiumcitrate
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Planned for surgery of thumb base arthrosis with trapeziectomy with ligament reconstruction tendon interposition. Age 18 years or older. low anesthetic risk, ASA class 1 or 2. Be able to take oral medication. Be able to read and communicate in Swedish. Exclusion Criteria: Age under 18 years. Heartfailure, kidney failure, ischemic hearth disease. Previous neuropathic pain or complex pain syndrome. Serious psychiatric morbidity Not able to communicate in Swedish Skin problems that makes the application of NoL-sensor impossible.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Magnesium<br>Given 1000 mg oral magnesiumcitrate once daily (4*250mg) during the day of surgery and the next 6 Days. | Dietary Supplement: magnesiumcitrate<br>* Magnesiumcitrate 250 mg, Apoteket AB, Sweden<br>|
| Placebo Comparator: Placebo<br>Given placebo once daily during the day of surgery and the next 6 Days. | Dietary Supplement: Placebo<br>* Ester-c<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain after 48 hours from surgery | Pain measured with a self reported written numerical rating scale with eleven steps 0-10 where 0 is no pain and 11 is the worst pain possible (NRS) after 48 h after surgery. | Self reported at 48 hours after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoR15swe (Quality of Recovery, a 15 item questionaire translated to swedish) | Recovery measured by QoR15swe day 1-7. A written form filled in by the patients and returned to the hospital by mail. QoR15 is a recovery score with 15 items that gives a score between 0-150. 0 points indicates worst possible recovery and 150 indicates best possible recovery. We are using a swedish translation validated by Lyckner et al 2018. | Day 1 to day 7 after surgery. | 
| Pain 1 hour after surgery | Pain measured with an oral numerical rating scale with eleven steps 0-10 where 0 is no pain and 11 is the worst pain possible (NRS) reported to the staff at the post operative ward 1 hour after surgery. | 1 hour after leaving the operating theatre |