Spinal administration of morphine for laparoscopic pancreatic surgery : A double blind, propspective randomized placebo-controlled trial.

Phase 1

• Conditions: postoperative pain treatment after minimally invasive pancreatic surgery; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2021-002625-20-BE
• Lead Sponsor: niversity Hospitals Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-15
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 128

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

- 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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