Patients planned to undergo elective lumbar spinal fusion surgery with a dorsal surgical approach
Conditions
Interventions
Trade Name: Ropivacaine HCl
Product Name: Ropivacaine HCl
Product Code: RVG104944
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Injection/infusion
Route of administra
Sponsors
Sint Maartenskliniek
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Age = 18 years; - Patients planned for elective lumbar spinal fusion surgery with a dorsal surgical approach; - 1-4 level spine fusion surgery; - Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 38 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 38
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the analgesic effect of ESPB on early postoperative pain after lumbar spinal fusion surgery.;Secondary Objective: The secondary objectives are to assess the effect of ESPB on: - 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; - 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.;Primary end point(s): The main study parameter of this study is the early pain intensity in the postoperative care unit after emergence from general anesthesia. Pain scores will be measured using NRS, a scale ranging from 0 to 10 (0 meaning no pain at all; 10 being the worst pain ever experienced). The NRS will be asked by a trained nurse not earlier than one hour after the patient emerges from general anesthesia in the PACU. The patient must have a Richmond Agitation-Sedation Scale (RASS) of 0 to minus 1 in order to determine NRS. If a patient is asleep, no NRS is measured until patient is awake.;Timepoint(s) of evaluation of this end point: After emergence from general anesthesia. The NRS will be asked by a trained nurse not earlier than one hour after the patient emerges from general anesthesia in the PACU. The patient must have a Richmond Agitation-Sedation Scale (RASS) of 0 to minus 1 in order to determine NRS. If a patient is asleep, no NRS is measured until patient is awake. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - 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 antiemetics 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 questionnaire7 (Dutch version QoR-15; 0-150) on postoperative day 1 and before discharge; - Complications up to 30 days postoperative.;Timepoint(s) of evaluation of this end point: see E.5.2. | — |
Countries
Netherlands
Contacts
Public ContactClinical Trial Information
Sint Maartenskliniek
Outcome results
None listed