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 - ARTEMIS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51208

Enrollment

Registered

2021-06-04

Start date

2021-07-01

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

Pelvic instability Sacroiliac joint dysfunction

Interventions

Intra-articular injection with 1.5-5 cc bupivacaine 0.25% or placebo (1.5-5 cc NaCl 0.9%)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)