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Tourniquet use in total knee replacement surgery: a feasibility study and pilot randomised controlled trial (SAFE-TKR study)
- Source :
- BMJ Open, BMJ Open, Vol 11, Iss 1 (2021)
- Publication Year :
- 2021
- Publisher :
- BMJ, 2021.
-
Abstract
- IntroductionTourniquets are routinely used during total knee replacement (TKR) surgery. They could increase the risk of thromboembolic events including cerebral emboli, cognitive decline, pain and other adverse events (AEs). A randomised controlled trial to assess whether tourniquet use might safely be avoided is therefore warranted but it is unclear whether such a trial would be feasible.MethodsIn a single-site feasibility study and pilot randomised controlled trial, adults having a TKR were randomised to surgery with an inflated tourniquet versus a non-inflated tourniquet. Participants underwent brain MRI preoperatively and within 2 days postoperatively. We assessed cognition using the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA) and Oxford Cognitive Screen (OCS) and thigh pain using a Visual Analogue Scale at baseline and days 1 and 2, and 1 week postsurgery. AEs related to surgery were recorded up to 12 months.ResultsWe randomised 53 participants (27 tourniquet inflated and 26 tourniquet not inflated). Fifty-one participants received care per-protocol (96%) and 48 (91%) were followed up at 12 months. One new ischaemic brain lesion was detected. Of the cognitive tests, MoCA was easy to summarise, sensitive to change with lower ceiling effects compared with OCS and MMSE. There was a trend towards more thigh pain (mean 49.6 SD 30.4 vs 36.2 SD 28 at day 1) and more AEs related to surgery (21 vs 9) in participants with an inflated tourniquet compared with those with a tourniquet not inflated.ConclusionA full trial is feasible, but using MRI as a primary outcome is unlikely to be appropriate or feasible. Suitable primary outcomes would be cognition measured using MoCA, pain and AEs, all of which warrant investigation in a large multicentre trial.Trial registration numberISRCTN20873088.
- Subjects :
- Adult
Visual analogue scale
lcsh:Medicine
knee
Pilot Projects
Total knee replacement surgery
law.invention
orthopaedic & trauma surgery
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
law
Humans
Medicine
adult surgery
030212 general & internal medicine
Cognitive decline
Arthroplasty, Replacement, Knee
Adverse effect
030222 orthopedics
Tourniquet
business.industry
lcsh:R
Montreal Cognitive Assessment
General Medicine
Tourniquets
Cognitive test
surgical procedures, operative
Treatment Outcome
Anesthesia
Feasibility Studies
Surgery
Female
business
Subjects
Details
- ISSN :
- 20446055
- Volume :
- 11
- Database :
- OpenAIRE
- Journal :
- BMJ Open
- Accession number :
- edsair.doi.dedup.....8aa9f1a1795b2aa5e557d92618f365b2