Erector Spinae Plane Block as Pain Management After Lumbar Fusion Surgery
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
Rationale: 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 for this type of surgery. The literature is not
yet conclusive about the effectiveness of this technique on reducing postoperative pain
intensity.
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 intensity 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.
Study population: 76 patients ≥ 18 years of age requiring elective lumbar spinal fusion
surgery involving two to four fusion levels.
Intervention: Patients will receive ultrasound-guided ESPB with either ropivacaine or placebo
at the end of surgery.
Main study parameters/endpoints: 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 endpoints are pain intensity during
hospital stay and after 30 days, opioid use during hospital stay and after 30 days, opioid
side effects, use of anti-emetics, time to first opioid use/request, length of hospital stay,
quality of recovery at discharge.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: 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.