Clinical trial NCT04613154: Magnesium as an Adjunct for Pain Treatment After Surgery for Thumb Base Arthrosis
Official title: Magnesium as an Adjunct for Pain Treatment After Surgery for Thumb Base Arthrosis, a Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Thumb Osteoarthritis
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain after 48 hours from surgery
timeFrame: Self reported at 48 hours after surgery.
Secondary outcomes:
measure: QoR15swe (Quality of Recovery, a 15 item questionaire translated to swedish)
timeFrame: Day 1 to day 7 after surgery.
measure: Pain 1 hour after surgery
timeFrame: 1 hour after leaving the operating theatre
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro University Hospital
state: Örebro Län
Study officials:
affiliation: Universitetssjukhuset Örebro, ANIVA-kliniken
name: Pether Jildenstål, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Oliveira GS Jr, Castro-Alves LJ, Khan JH, McCarthy RJ. Perioperative systemic magnesium to minimize postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2013 Jul;119(1):178-90. doi: 10.1097/ALN.0b013e318297630d.
citation: Shin HJ, Na HS, Do SH. Magnesium and Pain. Nutrients. 2020 Jul 23;12(8):2184. doi: 10.3390/nu12082184.
citation: Cowen R, Stasiowska MK, Laycock H, Bantel C. Assessing pain objectively: the use of physiological markers. Anaesthesia. 2015 Jul;70(7):828-47. doi: 10.1111/anae.13018. Epub 2015 Mar 14.
citation: Brown EN, Pavone KJ, Naranjo M. Multimodal General Anesthesia: Theory and Practice. Anesth Analg. 2018 Nov;127(5):1246-1258. doi: 10.1213/ANE.0000000000003668.
citation: Lyckner S, Boregard IL, Zetterlund EL, Chew MS. Validation of the Swedish version of Quality of Recovery score -15: a multicentre, cohort study. Acta Anaesthesiol Scand. 2018 Aug;62(7):893-902. doi: 10.1111/aas.13086. Epub 2018 Feb 7.
citation: Edry R, Recea V, Dikust Y, Sessler DI. Preliminary Intraoperative Validation of the Nociception Level Index: A Noninvasive Nociception Monitor. Anesthesiology. 2016 Jul;125(1):193-203. doi: 10.1097/ALN.0000000000001130.
citation: Yousef AA, Al-deeb AE. A double-blinded randomised controlled study of the value of sequential intravenous and oral magnesium therapy in patients with chronic low back pain with a neuropathic component. Anaesthesia. 2013 Mar;68(3):260-6. doi: 10.1111/anae.12107. Epub 2012 Dec 17.