An interventional study of magnesiumcitrate and Placebo in Thumb Osteoarthritis, sponsored by Region Örebro County. Terminated at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-25.
Sponsored by Region Örebro County · Not applicable, Interventional, and Treatment
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 9 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Region Örebro County is the lead sponsor of 123 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Given 1000 mg oral magnesiumcitrate once daily (4\*250mg) during the day of surgery and the next 6 Days.
Dietary Supplement: magnesiumcitrate
Given placebo once daily during the day of surgery and the next 6 Days.
Dietary Supplement: Placebo
Magnesiumcitrate 250 mg, Apoteket AB, Sweden
Ester-c
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.
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
Plan to share: No
This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Region Örebro County