The postoperative pain intensity after posterior interbody fusion surgery is often intense and difficult to treat with IV morphine and paracetamol alone. Besides, the use of opioids is often associated with important side effects. The aim of this research project is to evaluate the impact of a lidocaine infusion during surgery and during the first 4 postoperative hours on postoperative pain intensity and morphine consumption for one or two level posterior interbody fusion MedDRA version: 16.0
Conditions
Interventions
Trade Name: Linisol 2%
Product Name: lidocaine
Pharmaceutical Form: Infusion
INN or Proposed INN: lidocaine
CAS Number: 6108-05-0
Other descriptive name: LIDOCAINE HYDROCHLORIDE MONOHYDRATE
Concentrat
Sponsors
ZNA Middelheim
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General inclusion criteria for the study - Physical status ASA I-II (Table 1), aged between 18 and 75 years - indications for surgery: degenerative anterolysthesis with or without spinal stenosis, degenerative disc disease with or without spinal stenosis and spondylosis with or without lysthesis 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 84 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Primary exclusion criteria - ASA III-IV - Known allergy to local anesthetics - History of drug or alcohol abuse - Hepatic failure (defined as a history of cirrhosis or fulminant hepatic failure) - Chronic renal failure (defined as serum creatinine >2mg/dl) - Pregnancy - Breast feeding - Psychiatric disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary endpoints -Postoperative pain intensity -Postoperative opioid consumption ;Secondary Objective: Secondary endpoints: -Patient satisfaction on the 3rd postoperative day -Incidence of side-effects postoperatively -Amount of days until the patient can walk 50 meters independently ;Primary end point(s): -Postoperative pain intensity (NRS) -Postoperative opioid consumption (cumulative dose in mg/24h) ;Timepoint(s) of evaluation of this end point: - Preoperative pain scores (NRS) are registered for leg and back pain. Postoperatively, NRS will be noted at 30 minutes, 1, 4 and 6 hours after arrival at the PACU (day 0). On the following postoperative days (day 1 -3), NRS will be measured 3 times daily. - The postoperative morphine consumption will be registered every 24 hours and will be expressed as a cumulative dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Patient satisfaction on the 3rd postoperative day - Incidence of side-effects postoperatively - Amount of days until the patient can walk 50 meters independently ;Timepoint(s) of evaluation of this end point: - For assessment of the satisfaction about the postoperative pain management: NRS, identifying 10 as ‘extremely satisfied’ and 0 as ‘very dissatisfied’. Will be measured at the 3th postoperative day by asking the patient one question: “How satisfied are you about the pain management of the last 3 days”? - The side effects will be scored as follows: For the opioid related side effects, the Opioid Related Symptom Distress Scale (ORSDS) questionnaire will be filled in once daily from day 1 until the 3th postoperative day. On the day of surgery, sedation will be scored by the nurses at the same time points as the pain scoring (at 30 minutes, 1, 4 and 6 hours after surgery) using the POSS scale The incidence of cardiovascular side effects are noted daily (yes/no) and specified. | — |
Countries
Belgium
Contacts
Public ContactMarie Van Remoortere
ZNA Middelheim
Outcome results
None listed