Postoperative pain treatment after uniportal videoscopic assisted thoracic surgery (VATS). MedDRA version: 21.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Naropin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Naropin
CAS Number: 132112-35-7
Other descriptive name: ROPIVACAINE HYDROCHLORIDE MONOHYDRATE
Concentration unit: %
Sponsors
University Hospitals Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 18-80 years of age - Body Mass Index (BMI) = 40 kg/m2 - Patient is able to give informed consent - Patient understands the use of morphine PCIA - Patient is scheduled for elective uVATS - ASA I-IV 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: - Refusal to participate in the trial - Inability to operate a PCIA system - Chronic opioid use, or chronic pain patient - Presence of contra-indications for study medication (local anesthetic allergy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of the erector spinae block with the intercostal nerve block.;Secondary Objective: not applicable;Primary end point(s): Cumulative 12-hour morphine consumption post-surgery. ;Timepoint(s) of evaluation of this end point: 12 hours after start of PCIA | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Cumulative 24-hour morphine consumption post-surgery (=key secondary endpoint). - Pain intensity as assessed with the numerical rating scale (NRS) for pain - Requested dosage of morphine, administered via patient-controlled intravenous analgesia (PCIA) - Need for and dose of rescue analgesia - Incidence of postoperative surgical complications as assessed with the Clavien-Dindo Classification for complications after VATS - Day of discharge - Time to be fit for discharge as defined by reaching all the following criteria: o Oral pain medication only o Independent walking o Bowel movement o Time to first flatus (TFF) o Time to first stool (TFS) o Full oral diet o Hemodynamically (90% of baseline BP, HR in 90% or normal range) and respiratory stable (no need for extra oxygen) o No drains or urinary catheters ;Timepoint(s) of evaluation of this end point: Pain scores will be monitored every 15min after arrival in the PACU until the first 2H postoperatively. Every other endpoint will be evaluated daily until patient discharge | — |
Countries
Belgium
Contacts
Public ContactResearch anesthesie
University Hopitals Leuven
Outcome results
None listed