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A Randomised controlled Trial on the Effect of local analgesia for pain relief after Minimal Invasive Sacro-Iliac joint fusion

A Randomised controlled Trial on the Effect of local analgesia for pain relief after Minimal Invasive Sacro-Iliac joint fusion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28172
Enrollment
42
Registered
2020-12-29
Start date
2021-01-31
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sacroiliac joint dysfunction

Interventions

Minimally invasive sacroiliac joint fusion will be performed as standard care. The patient is placed in prone position. Intraoperative fluorscopy is used during surgery for optimal placement of implan

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
The group difference in cumulative opioid use at recovery, 2, 4, 6, 24 and 48h after surgery. 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. 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. Hospital stay defined as days spent in hospital after surgery.

Contacts

Public ContactSem Hermans

Zuyderland Medical Center

se.hermans@zuyderland.nl+31627453199

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)