NCT04613154

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

September 24, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 3, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2023

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

3 years

First QC Date

September 24, 2020

Last Update Submit

October 23, 2023

Conditions

Thumb Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • 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.

    Self reported at 48 hours after surgery.

Secondary Outcomes (2)

  • QoR15swe (Quality of Recovery, a 15 item questionaire translated to swedish)

    Day 1 to day 7 after surgery.

  • Pain 1 hour after surgery

    1 hour after leaving the operating theatre

Study Arms (2)

Magnesium

ACTIVE COMPARATOR

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

Dietary Supplement: magnesiumcitrate

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

magnesiumcitrateDIETARY_SUPPLEMENT

Magnesiumcitrate 250 mg, Apoteket AB, Sweden

Magnesium
PlaceboDIETARY_SUPPLEMENT

Ester-c

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Örebro University Hospital

Örebro, Örebro County, 701 85, Sweden

Location

Related Publications (7)

  • 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.

    PMID: 23669270BACKGROUND

  • Shin HJ, Na HS, Do SH. Magnesium and Pain. Nutrients. 2020 Jul 23;12(8):2184. doi: 10.3390/nu12082184.

    PMID: 32718032BACKGROUND

  • 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.

    PMID: 25772783BACKGROUND

  • 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.

    PMID: 30252709BACKGROUND

  • 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.

    PMID: 29417552BACKGROUND

  • 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.

    PMID: 27171828BACKGROUND

  • 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.

    PMID: 23384256BACKGROUND

Study Officials

  • Pether Jildenstål, phd

    Universitetssjukhuset Örebro, ANIVA-kliniken

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Closed envelope randomisation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2020

First Posted

November 3, 2020

Study Start

September 24, 2020

Primary Completion

October 10, 2023

Study Completion

October 10, 2023

Last Updated

October 25, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)