Research into the effect of local anesthetic as additional pain relief after surgery on the lower back

Erector spinae plane block for reduction of early postoperative pain scores and opioid use in lumbar spinal fusion surgery, a prospective double-blinded randomized placebo-controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26038

Enrollment

Registered

2021-08-02

Start date

2022-02-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Spondylolisthesis, lumbar disc herniation

Interventions

Erector Spinae Plane Block injection with ropivacaine

Eligibility

Inclusion criteria

Inclusion criteria: • Age = 18 years; • Patients planned for elective lumbar spinal fusion surgery with a dorsal surgical approach; • 2-4 level spine fusion surgery; • Written informed consent.

Exclusion criteria

Exclusion criteria: • A Body Mass Index (BMI) > 40 kg/m²; • ASA physical health classification > 3; • Patients who will undergo spine surgery involving less than 2 or more than 4 levels of fusion, scoliosis 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; • Inability to speak or understand the Dutch language.

Design outcomes

Primary

Measure	Time frame
Pain intensity in the postoperative care unit upon emergence, using the Numeric Rating Scale (NRS) for pain	—

Secondary

Measure	Time frame
- Acceptability of pain; - Opioid use in cumulative morphine equivalent dose (MEQ) in the postoperative care unit and in the first 24 hours after surgery; - Opioid side effects such as nausea, vomiting and use of anti-emetics in the postoperative care unit and in the first 24 hours after surgery; - Time to first opioid use/request; - Time to first mobilization; - Length of hospital stay; - Pain intensity on postoperative admission days, before discharge from hospital, and after 30 days; - Opioid use 30 days after surgery; - Quality of recovery on postoperative day 1 and before discharge; - Complications up to 30 days postoperative.	—

Measure

Time frame

- Acceptability of pain; - Opioid use in cumulative morphine equivalent dose (MEQ) in the postoperative care unit and in the first 24 hours after surgery; - Opioid side effects such as nausea, vomiting and use of anti-emetics in the postoperative care unit and in the first 24 hours after surgery; - Time to first opioid use/request; - Time to first mobilization; - Length of hospital stay; - Pain intensity on postoperative admission days, before discharge from hospital, and after 30 days; - Opioid use 30 days after surgery; - Quality of recovery on postoperative day 1 and before discharge; - Complications up to 30 days postoperative.

—

Contacts

Public ContactIlse van de Wijgert

Sint Maartenskliniek

i.vandewijgert@maartenskliniek.nl+31 24 327 2593

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)