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

Completed

Conditions: Pelvic instability
Sacroiliac joint dysfunction
10023213

Registration Number: NL-OMON51208

Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 44

Inclusion Criteria

1. Indication for MISJF surgery.
2. Age over and equal to 18 years.
3. Informed consent prior to this study.

Exclusion Criteria

1. Revision surgery.
2. Intraoperative inability to infiltrate the SI joint.
3. Contra-indications for the use of bupivacaine or other amide type local
anesthetics, anesthesia or surgery.
4. Inadequate command of the Dutch language.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints: group difference in NRS pain score during the first 48h<br /><br>after surgery between intervention and placebo, with interval measurements at<br /><br>recovery entry, recovery exit, 2, 4, 6 and 24 hours.<br /><br>Secondary endpoints: Total postoperative opioid consumption at 48 hours<br /><br>postoperatively with interim measurements at 2, 4, 6 and 24 hours. Patient<br /><br>satisfaction (measured by EQ-5D and GSRI), hospital stay in days and number of<br /><br>adverse events.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. To determine whether SI joint infiltration with bupivacaine 0.25% leads to a<br /><br>reduction in cumulative opioid use until 48 hours postoperatively with<br /><br>measurements at 2, 4, 6, 24 and 48 hours compared to placebo.<br /><br><br /><br>2. To determine whether SI joint infiltration with bupivacaine 0.25% leads to<br /><br>higher patient satisfaction than placebo.<br /><br><br /><br>3. To determine whether SI joint infiltration with bupivacaine 0.25% leads to<br /><br>shorter hospital stay than placebo.<br /><br><br /><br>4. To determine whether SI joint infiltration with bupivacaine 0.25% leads to<br /><br>less adverse events than placebo. </p><br>