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

Region Örebro County

Status: Terminated

Conditions: Thumb Osteoarthritis

Treatments: Dietary Supplement: Placebo; Dietary Supplement: magnesiumcitrate

Study type: Interventional

Funder types: Other

Identifiers

NCT04613154

272919

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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9 participants in 2 patient groups, including a placebo group

Magnesium

Active Comparator group

Description:

Given 1000 mg oral magnesiumcitrate once daily (4\*250mg) during the day of surgery and the next 6 Days.

Treatment:

Dietary Supplement: magnesiumcitrate

Placebo

Placebo Comparator group

Description:

Given placebo once daily during the day of surgery and the next 6 Days.

Treatment:

Dietary Supplement: Placebo