To determine whether SI infiltration with 1.5-5cc bupivacaine 0.25% is superior to placebo (intraarticular injection of 1.5-5cc NaCl 0.9%) in reducing wound pain in patients after MISJF, and to determine whether opioid use in the 2 days after…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Minimally invasive sacroiliac joint fusion (MISJF) is a surgical procedure to
treat chronic low back pain due to sacroiliac (SI) dysfunction. During the
minimally invasive procedure, the SI joint is stabilized by implants inserted
percutaneously under fluoroscopy guidance. Postoperatively, patients often
report a lot of pain, which contributes to patients taking high doses of
painkillers (opioids e.g.) and preventing early mobilization.
Study objective
To determine whether SI infiltration with 1.5-5cc bupivacaine 0.25% is superior
to placebo (intraarticular injection of 1.5-5cc NaCl 0.9%) in reducing wound
pain in patients after MISJF, and to determine whether opioid use in the 2 days
after surgery is significantly higher in the placebo group.
Study design
Double Blinded Randomized Controlled Trial (blinding for the patient,
clinician, researcher and statistician).
Intervention
Intra-articular injection with 1.5-5 cc bupivacaine 0.25% or placebo (1.5-5 cc
NaCl 0.9%)
Study burden and risks
Infiltration of the SI joint is currently standard care for orthopedic surgeons
and anesthesiologists worldwide. It is done to diagnose and treat SI
dysfunction. Intraoperatively infiltrating the SI joint has been performed by
several spine surgeons, including the team in Zuyderland MC. Minimally invasive
sacroiliac joint fusion is generally perceived as a painful procedure. Pain
prevents patients to mobilize properly after surgery, which increases
complication risk. Postoperative pain is classically treated using opioids,
which themselves have side effects and impact on the length of hospital stay.
The burden for patients participating in this randomized trial is low.
Patients are asked to fill out a questionnaire (EuroQol - 5D and General
Surgery Recovery Index) concerning Patient Related Outcome Measurements
(PROMS). As part of the study, NRS pain scores are additionally taken at 2, 4,
6, 24 and 48 hours after surgery. There are no extra visits to the outpatient
clinic. There are no benefits in participating in this study compared to care
as usual.
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Henri Dunantstraat 5
Heerlen 6419 PC
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76457.096.21 |
| Other | NL9151 |