The objective of this study is to evaluate the analgesic effect of ESPB as add-on therapy to multimodal analgesia on early postoperative pain after lumbar spinal fusion surgery compared to placebo.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
pijnbestrijding bij lumbale wervelkolomchirurgie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter is pain intensity upon emergence from anesthesia measured
with the Numeric Rating Scale. A minimal clinically important difference is
considered to be a decrease of 1.5 points.
Secondary outcome
Secondary endpoints are:
• Acceptability of pain (yes/no);
• Opioid use in cumulative morphine equivalent (MEQ) dose in the postoperative
care unit and in the first 24 hours after surgery, extracted from the EMF and
PCIA pump (MEQ, dose);
• Presence of opioid side effects: nausea, vomiting and use of anti-emetics in
the postoperative care unit and in the first 24 hours after surgery (yes/no);
• Time to first opioid use/request (minutes);
• Length of hospital stay (days);
• Pain intensity on postoperative admission days, before discharge from
hospital, and after 30 days (NRS for pain; 0-10);
• Opioid use 30 days after surgery (yes/no, dose);
• Quality of recovery (QoR) using the QoR-15 questionnaire (Dutch version ?;
0-150) on postoperative day 1 and before discharge;
• Complications up to 30 days postoperative.
Background summary
Lumbar spine surgery is associated with high postoperative pain scores and
analgesic use, despite use of multimodal analgesia. The erector spinae plane
block (ESPB) is a promising locoregional anesthetic technique. The literature
is not yet conclusive about the effectiveness of this technique on reducing
postoperative pain scores.
Study objective
The objective of this study is to evaluate the analgesic effect of ESPB as
add-on therapy to multimodal analgesia on early postoperative pain after lumbar
spinal fusion surgery compared to placebo.
Study design
The study is designed as a prospective mono-centre, randomized, double-blinded,
placebo-controlled trial.
Intervention
Patients will receive ultrasound-guided ESPB with either Ropivacaine or normal
saline at the end of surgery.
Study burden and risks
The Sint Maartenskliniek is experienced in applying locoregional analgesia, the
use of Ropivacaine and using sonography. The procedure of administering ESPB
has a very low risk of complications. Receiving placebo is justifiable because
this group will not be withhold standard treatment. The risks of receiving
placebo are negligible. The patients will visit the clinic at regular follow-up
moments.
Hengstdal 3
Ubbergen 6574NA
NL
Hengstdal 3
Ubbergen 6574NA
NL
Listed location countries
Age
Inclusion criteria
• Age >= 18 years;
• Patients planned for elective lumbar spinal fusion surgery with a dorsal
surgical approach;
• 1-4 levels of spine fusion surgery;
• Written informed consent.
Exclusion criteria
• A Body Mass Index (BMI) > 40 kg/m²;
• ASA physical health classification > 3;
• Patients who will undergo spine surgery involving more than 4 levels of
fusion, scoliosis surgery;
• Patients who will undergo minimally invasive surgery;
• Patients who will undergo circumferent spine surgery;
• Patients with an active, local infection or systemic infection;
• Patients with an allergy to one or more medications used in the study;
• Patients with any contraindication to a regional anesthetic technique;
• Kidney- or liver failure inhibiting the systemic use of paracetamol and/or
NSAIDs;
• Acute surgeries;
• Patients with a history of drugs or alcohol abuse;
• Pregnancy;
• Cognitive impairment.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2021-003679-32-NL |
| CCMO | NL77885.091.21 |
| Other | NL9640 |