EUCTR2021-002625-20-BE
Active, not recruiting
Phase 1
Intrathecal morphine administration for minimally invasive pancreatic surgery: A double blind, prospective randomized placebo-controlled trial. - IT morphine for MIPS
niversity Hospitals Leuven0 sites128 target enrollmentJune 15, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- postoperative pain treatment after minimally invasive pancreatic surgery
- Sponsor
- niversity Hospitals Leuven
- Enrollment
- 128
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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\)
Outcomes
Primary Outcomes
Not specified
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