Magnesium as an Adjunct for Pain Treatment After Surgery for Thumb Base Arthrosis
Primary Purpose
Thumb Osteoarthritis
Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
magnesiumcitrate
Placebo
Sponsored by

About this trial
This is an interventional treatment trial for Thumb Osteoarthritis
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.
Sites / Locations
- Örebro University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Magnesium
Placebo
Arm Description
Given 1000 mg oral magnesiumcitrate once daily (4*250mg) during the day of surgery and the next 6 Days.
Given placebo once daily during the day of surgery and the next 6 Days.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04613154
First Posted
September 24, 2020
Last Updated
October 23, 2023
Sponsor
Region Örebro County
1. Study Identification
Unique Protocol Identification Number
NCT04613154
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Change in hospital organisation. A large reduction number of patients undergoing surgery.
Study Start Date
September 24, 2020 (Actual)
Primary Completion Date
October 10, 2023 (Actual)
Study Completion Date
October 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Örebro County
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thumb Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Closed envelope randomisation.
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magnesium
Arm Type
Active Comparator
Arm Description
Given 1000 mg oral magnesiumcitrate once daily (4*250mg) during the day of surgery and the next 6 Days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Given placebo once daily during the day of surgery and the next 6 Days.
Intervention Type
Dietary Supplement
Intervention Name(s)
magnesiumcitrate
Intervention Description
Magnesiumcitrate 250 mg, Apoteket AB, Sweden
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Ester-c
Primary Outcome Measure Information:
Title
Pain after 48 hours from surgery
Description
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 Outcome Measure Information:
Title
QoR15swe (Quality of Recovery, a 15 item questionaire translated to swedish)
Description
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.
Title
Pain 1 hour after surgery
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pether Jildenstål, phd
Organizational Affiliation
Universitetssjukhuset Örebro, ANIVA-kliniken
Official's Role
Principal Investigator
Facility Information:
Facility Name
Örebro University Hospital
City
Örebro
State/Province
Örebro Län
ZIP/Postal Code
701 85
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23669270
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.
Results Reference
background
PubMed Identifier
32718032
Citation
Shin HJ, Na HS, Do SH. Magnesium and Pain. Nutrients. 2020 Jul 23;12(8):2184. doi: 10.3390/nu12082184.
Results Reference
background
PubMed Identifier
25772783
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.
Results Reference
background
PubMed Identifier
30252709
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.
Results Reference
background
PubMed Identifier
29417552
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.
Results Reference
background
PubMed Identifier
27171828
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.
Results Reference
background
PubMed Identifier
23384256
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.
Results Reference
background
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Magnesium as an Adjunct for Pain Treatment After Surgery for Thumb Base Arthrosis
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