postoperative pain treatment after minimally invasive pancreatic surgery
Conditions
Interventions
Trade Name: Morphine HCL Sterop
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Morphine HCL Sterop
CAS Number: 52-26-6
Other descriptive name: MORPHINE HYDROCHLORIDE
Concentration un
Sponsors
University Hospitals Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 18-80 years of age - BMI = 40 kg/m2 - Patient is able to give informed consent - Patient understands the use of morphine PCIA - Patient is scheduled for elective minimally invasive pancreatic surgery - 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 64 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 64
Exclusion criteria
Exclusion criteria: - Refusal to participate in the trial - Inability to operate a PCIA system - Chronic opioid use, or chronic pain patient - Obstructive sleep apnea syndrome (OSAS) requiring CPAP therapy - If patient is known with kidney disease or renal dysfunction, the GFR will be checked and patient will be excluded if GFR < 30 mL/min. - Neuraxial anesthesia will only be performed with normal clotting lab results (UZ Leuven): - Thrombocytes = 80 x 109/L - INR = 1,5 - aPTT (s) = 31 - Presence of contra-indications for spinal anesthesia (patients on anticoagulants, coagulation deficits, severe spinal canal stenosis, neurological deficits, increased intracranial pressure, severe aortic stenosis as defined by aortic valve area (AVA) < 1 cm2) - Presence of contra-indications for intrathecal medication (pre-operative respiratory oxygen need, sleep apnea disorder, diamorphine/morphine allergy, local anesthetic allergy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the efficacy of intrathecal morphine after minimally invasive pancreatic surgery;Secondary Objective: not applicable;Primary end point(s): -Cumulative 24-hour morphine consumption post-surgery. ;Timepoint(s) of evaluation of this end point: 24 hours after start PCIA | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Cumulative 48-hour morphine consumption post-surgery (=key secondary endpoint). - Pain intensity as assessed with the numerical rating score (NRS) for pain - Requested dosage of morphine, administered via patient-controlled intravenous analgesia (PCIA) - Need for and dose of rescue analgesia - Plasma levels of C-reactive protein, interleukin (IL)- 6 and -10, cortisol and glucose levels at the end of surgery - Incidence of postoperative surgical complications as assessed with the Clavien-Dindo Classification for complications after laparoscopic pancreatic surgery - Day of discharge - Time to be fit for discharge as defined by reaching all of 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 catheter - Need for prolonged opioid use at home (assessed with telephone interview every two weeks, during 2 postoperative months postoperatively and with a pain diary) - Weight loss measured at the 4-6 weeks postoperative outpatient visit ;Timepoint(s) of evaluation of this end point: ain scores will be monitored every 15 min aftrer arrival in the PACU until the first 2H post operatively; then once per hour until 4H postoperatively. Every other endpoint will be evaluated once daily until patient discharge | — |
Countries
Belgium
Contacts
Public ContactResearch Anesthesiology
University Hospitals Leuven
Outcome results
None listed