Most patients undergoing spine surgery with pedicle screw instrumentation will experience insufficient pain relief in the first three days after surgery, whereafter postoperative pain can be managed with conventional, non-opioid analgesics in most…
ID
Source
Brief title
Condition
- Nervous system, skull and spine therapeutic procedures
Health condition
Various spinal pathologies requiring surgical stabilization
Research involving
Sponsors and support
Intervention
- Surigical procedure
Outcome measures
Primary outcome
Pain, opioid usage and mobilization
Secondary outcome
Medicine use, side-effects, adverse events, length of stay in the hospital, discharge destination, and patient satisfaction
Background summary
Pain management after musculoskeletal surgery remains a major challenge. Despite 95% of patients receiving systemic opioids, which are associated with many toxic side effects and are highly addictive, inadequate pain is still reported in up to 80% of patients. The current study aims to quantify the incidence of insufficient pain relief after instrumented spine surgery and to analyse the relationship between postoperative pain, opioid consumption and mobilization.
Study objective
Most patients undergoing spine surgery with pedicle screw instrumentation will experience insufficient pain relief in the first three days after surgery, whereafter postoperative pain can be managed with conventional, non-opioid analgesics in most cases.
Study design
Up to 10 days postoperatively
Intervention
Spinal instrumentation using pedicle screws
Age
Inclusion criteria
- Males and females aged 18 years and older - Planned for open or percutaneous* posterior instrumentation with a minimum of 4 new pedicle screws with a diameter of 5 to 7,5 mm (inclusive). - Concomitant posterolateral fusion, vertebral augmentation, intervertebral body fusion devices, osteotomies and posterior decompression are acceptable - Willing and able to comply with the protocol for the duration of the study - Give written informed consent prior to any study-related procedure not part of the standard practice, with the understanding that the consent may be withdrawn by the patient at any time without prejudice to his/her (post-)surgery care
Exclusion criteria
- Concomitant anterior/lateral procedures (e.g. vertebral cage, anterior plating, ALIF/XLIF) - ASA-classification > 3 - Disrupted pain perception according to the treating physician - High risk of intra-/postoperative complications (e.g. multiple prior procedures) - Indication for surgery being: Active or previous (para)spinal infection; Malignancy; Fracture/other traumatic injury; Indication for an epidural catheter; Indication for local infiltration analgesics with amino-amide anesthetics; Known intolerance to patch adhesives; Participation in an interventional study interfering with standard care
Design
Recruitment
IPD sharing statement
Dr. Nassaulaan 10
9401 HK Assen
059 2405871
info@stbebo.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9703 |
| Other | Dutch Clinical Research Foundation : NWMO21.05.022 |