Study protocol for a randomised controlled trial on the effect of local analgesia for pain relief after minimal invasive sacroiliac joint fusion: the ARTEMIS study
Introduction Chronic lower back pain is a common report in the general population. A dysfunctional sacroiliac joint (SIJ) is estimated to be responsible for one in five patients with lower back pain. Minimally invasive sacroiliac joint fusion (MISJF) is a surgical procedure to treat SIJ dysfunction....
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BMJ Publishing Group
2021-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/11/12/e056204.full |
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| author | Kris L L Movig Sem M M Hermans Jorm M Nellensteijn Henk van Santbrink Rob Knoef Mattheus K Reinders Daisy M N Hoofwijk Jan W Potters Inez Curfs Wouter L W van Hemert |
| author_facet | Kris L L Movig Sem M M Hermans Jorm M Nellensteijn Henk van Santbrink Rob Knoef Mattheus K Reinders Daisy M N Hoofwijk Jan W Potters Inez Curfs Wouter L W van Hemert |
| author_sort | Kris L L Movig |
| collection | DOAJ |
| description | Introduction Chronic lower back pain is a common report in the general population. A dysfunctional sacroiliac joint (SIJ) is estimated to be responsible for one in five patients with lower back pain. Minimally invasive sacroiliac joint fusion (MISJF) is a surgical procedure to treat SIJ dysfunction. During the procedure, the SIJ is stabilised by implants inserted percutaneously under fluoroscopy guidance. Postoperatively, patients often report a lot of pain, which contributes to patients taking high doses of painkillers (opioids for example,) and preventing early mobilisation. In several orthopaedic procedures, intraoperative infiltration of the wound bed results in decreased consumption of analgesics, earlier mobilisation and shorter hospitalisation time. The aim of this study is to investigate the effectiveness of intraoperative SIJ infiltration with analgesia in reducing postoperative pain after MISJF.Methods and analysis We will perform a two-centre, prospective, double-blind, randomised controlled trial to determine whether SIJ infiltration with 1.5–5 cc bupivacaine 0.50% is superior to 1.5–5 cc placebo (NaCl 0.9%) in reducing postoperative pain in patients after MISJF, and to determine whether bupivacaine significantly reduces opioid use in the direct postoperative period. Patients will be randomised with 1:1 allocation for either bupivacaine (intervention) or placebo SIJ infiltration. Postoperative pain will be measured by the Visual Analogue Scale pain score at entry and exit recovery, 2, 4, 6, 24 and 48 hours postoperatively.Ethics and dissemination This is the first trial that investigates the effectiveness of intraoperative SIJ infiltration with bupivacaine 0.50% in reducing postoperative pain after MISJF. If intraoperative SIJ infiltration with bupivacaine 0.50% proves to be effective, this might have important clinical implications, such as postoperative analgesics (opioids for example,) consumption, earlier mobilisation and potentially shorter hospitalisation time.Trial registration number NL9151. |
| format | Article |
| id | doaj-art-8f0b6237b23d453abeb199783a0ecf53 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-12-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-8f0b6237b23d453abeb199783a0ecf532025-08-20T02:48:43ZengBMJ Publishing GroupBMJ Open2044-60552021-12-01111210.1136/bmjopen-2021-056204Study protocol for a randomised controlled trial on the effect of local analgesia for pain relief after minimal invasive sacroiliac joint fusion: the ARTEMIS studyKris L L Movig0Sem M M Hermans1Jorm M Nellensteijn2Henk van Santbrink3Rob Knoef4Mattheus K Reinders5Daisy M N Hoofwijk6Jan W Potters7Inez Curfs8Wouter L W van Hemert9Department of Clinical Pharmacy, Medical Spectrum Twente, Enschede, NetherlandsCaphri School of Public Health an Primary Care, Maastricht University, Maastricht, The NetherlandsOrthopaedic Surgery, Medical Spectrum Twente, Enschede, NetherlandsDepartment of Neurosurgery, Maastricht University Medical Centre+, Maastricht, Limburg, The NetherlandsOrthopaedic Surgery, Medical Spectrum Twente, Enschede, NetherlandsClinical Pharmacy, Pharmacology and Toxicology, Zuyderland Medical Centre Heerlen, Heerlen, Limburg, NetherlandsAnaesthesiology, Zuyderland Medical Centre Heerlen, Heerlen, Limburg, NetherlandsAnaesthesiology, Medical Spectrum Twente, Enschede, Netherlands14 Department of Orthopaedic Surgery and Traumatology, Zuyderland Medical Centre, Heerlen, The NetherlandsDepartment of Orthopedic Surgery and Traumatology, Zuyderland Medical Centre Heerlen, Heerlen, The NetherlandsIntroduction Chronic lower back pain is a common report in the general population. A dysfunctional sacroiliac joint (SIJ) is estimated to be responsible for one in five patients with lower back pain. Minimally invasive sacroiliac joint fusion (MISJF) is a surgical procedure to treat SIJ dysfunction. During the procedure, the SIJ is stabilised by implants inserted percutaneously under fluoroscopy guidance. Postoperatively, patients often report a lot of pain, which contributes to patients taking high doses of painkillers (opioids for example,) and preventing early mobilisation. In several orthopaedic procedures, intraoperative infiltration of the wound bed results in decreased consumption of analgesics, earlier mobilisation and shorter hospitalisation time. The aim of this study is to investigate the effectiveness of intraoperative SIJ infiltration with analgesia in reducing postoperative pain after MISJF.Methods and analysis We will perform a two-centre, prospective, double-blind, randomised controlled trial to determine whether SIJ infiltration with 1.5–5 cc bupivacaine 0.50% is superior to 1.5–5 cc placebo (NaCl 0.9%) in reducing postoperative pain in patients after MISJF, and to determine whether bupivacaine significantly reduces opioid use in the direct postoperative period. Patients will be randomised with 1:1 allocation for either bupivacaine (intervention) or placebo SIJ infiltration. Postoperative pain will be measured by the Visual Analogue Scale pain score at entry and exit recovery, 2, 4, 6, 24 and 48 hours postoperatively.Ethics and dissemination This is the first trial that investigates the effectiveness of intraoperative SIJ infiltration with bupivacaine 0.50% in reducing postoperative pain after MISJF. If intraoperative SIJ infiltration with bupivacaine 0.50% proves to be effective, this might have important clinical implications, such as postoperative analgesics (opioids for example,) consumption, earlier mobilisation and potentially shorter hospitalisation time.Trial registration number NL9151.https://bmjopen.bmj.com/content/11/12/e056204.full |
| spellingShingle | Kris L L Movig Sem M M Hermans Jorm M Nellensteijn Henk van Santbrink Rob Knoef Mattheus K Reinders Daisy M N Hoofwijk Jan W Potters Inez Curfs Wouter L W van Hemert Study protocol for a randomised controlled trial on the effect of local analgesia for pain relief after minimal invasive sacroiliac joint fusion: the ARTEMIS study BMJ Open |
| title | Study protocol for a randomised controlled trial on the effect of local analgesia for pain relief after minimal invasive sacroiliac joint fusion: the ARTEMIS study |
| title_full | Study protocol for a randomised controlled trial on the effect of local analgesia for pain relief after minimal invasive sacroiliac joint fusion: the ARTEMIS study |
| title_fullStr | Study protocol for a randomised controlled trial on the effect of local analgesia for pain relief after minimal invasive sacroiliac joint fusion: the ARTEMIS study |
| title_full_unstemmed | Study protocol for a randomised controlled trial on the effect of local analgesia for pain relief after minimal invasive sacroiliac joint fusion: the ARTEMIS study |
| title_short | Study protocol for a randomised controlled trial on the effect of local analgesia for pain relief after minimal invasive sacroiliac joint fusion: the ARTEMIS study |
| title_sort | study protocol for a randomised controlled trial on the effect of local analgesia for pain relief after minimal invasive sacroiliac joint fusion the artemis study |
| url | https://bmjopen.bmj.com/content/11/12/e056204.full |
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