A Randomised controlled Trial on the Effect of local analgesia for pain relief after Minimal Invasive Sacro-Iliac joint fusio
- Conditions
- Sacroiliac joint dysfunction
- Registration Number
- NL-OMON28172
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 42
Inclusion Criteria
1.Indication for MISJF surgery.
2.Age over 18 years.
3.Psychosocially, mentally, and physically able to fully comply with this study protocol.
4.Informed consent prior to this study.
Exclusion Criteria
1.Revision surgery.
2.Contra-indications for the use of bupivacaine or other amide type local anesthetics, anesthesia or surgery.
3.Inadequate command of the Dutch language.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is the group difference in VAS between intervention and placebo during the first 48h after surgery. With interval measurements at recovery entry, recovery exit, 2, 4, 6, 24 and 48 hours.
- Secondary Outcome Measures
Name Time Method The group difference in cumulative opioid use at recovery, 2, 4, 6, 24 and 48h after surgery.<br><br>Patient satisfaction measured using General Surgery Recovery Index (GSRI) and Visual Analogue Scale (VAS) satisfaction. Patients will fill out the questionnaire 24 hours after surgery. In addition, VAS leg pain and back pain will be filled out 24 hours after surgery. <br><br>Adverse events; postoperative infection, deep venous thrombosis, hematoma, neurological deficits and other complications as pneumonia, urine retention or urinary tract infection. Adverse events will be followed up to 30 days. <br><br>Hospital stay defined as days spent in hospital after surgery.