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

Phase 4

Recruiting

Conditions: pijnbestrijding bij lumbale wervelkolomchirurgie
acute pain after lumbar spine surgery

Registration Number: NL-OMON54322

Lead Sponsor: Sint Maartenskliniek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 76

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter is pain intensity upon emergence from anesthesia measured<br /><br>with the Numeric Rating Scale. A minimal clinically important difference is<br /><br>considered to be a decrease of 1.5 points. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are:<br /><br>• Acceptability of pain (yes/no);<br /><br>• Opioid use in cumulative morphine equivalent (MEQ) dose in the postoperative<br /><br>care unit and in the first 24 hours after surgery, extracted from the EMF and<br /><br>PCIA pump (MEQ, dose);<br /><br>• Presence of opioid side effects: nausea, vomiting and use of anti-emetics in<br /><br>the postoperative care unit and in the first 24 hours after surgery (yes/no);<br /><br>• Time to first opioid use/request (minutes);<br /><br>• Length of hospital stay (days);<br /><br>• Pain intensity on postoperative admission days, before discharge from<br /><br>hospital, and after 30 days (NRS for pain; 0-10);<br /><br>• Opioid use 30 days after surgery (yes/no, dose);<br /><br>• Quality of recovery (QoR) using the QoR-15 questionnaire (Dutch version ?;<br /><br>0-150) on postoperative day 1 and before discharge;<br /><br>• Complications up to 30 days postoperative.</p><br>