Post-operative outcomes of pain management in spinal fusion surgery
- Conditions
- <p>Various spinal pathologies requiring surgical stabilization</p>10009720
- Registration Number
- NL-OMON23831
- Lead Sponsor
- SentryX
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 66
- 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prior to any study-related procedure not part of the standard practice, with the understanding that the consent may be withdrawn by the patient at any time without prejudice to his/her (post-)surgery care
- 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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pain, opioid usage and mobilization</p><br>
- Secondary Outcome Measures
Name Time Method <p>Medicine use, side-effects, adverse events, length of stay in the hospital, discharge destination, and patient satisfaction</p><br>