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

Region Örebro County9 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Thumb Osteoarthritis

Interventions

magnesiumcitrateDIETARY_SUPPLEMENT

Magnesiumcitrate 250 mg, Apoteket AB, Sweden

PlaceboDIETARY_SUPPLEMENT

Ester-c

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Örebro University Hospital

Örebro, Örebro County, Sweden

Outcomes

Primary Outcomes

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.

Time frame: Self reported at 48 hours after surgery.

Secondary Outcomes

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.

Time frame: 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.

Time frame: 1 hour after leaving the operating theatre

Data from ClinicalTrials.gov

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