- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02284282
Spinal Bupivacaine/Morphine in Laparoscopic Gastro-intestinal Surgery (Salmon)
Study Overview
Status
Intervention / Treatment
Detailed Description
We expect that in laparoscopic gastro-intestinal surgery, a single shot spinal with bupicavaine/morphine will result in a better analgesia in hte first 48 hours. Herby the patients will require less systemic opioids, which will decrease the side-effects. Furthermore, we expect the patients to recover quicker and show an earlier mobilisation and a shorter hospital stay.
The objective of this study is to determine if a single spinal shot of morphine can decrease post-operative opioid-use, and thereby decrease opioid side-effects and lead to a quicker recovery after surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Rotterdam, Netherlands, 3079DZ
- Maasstad Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Laparoscopic Gastro-intestinal surgery
Exclusion Criteria:
- Bariatric surgery, gastric surgery, rectal surgery, kidney failure, aorta-valve stenosis, coagulation disorders, emergency surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Spinal injection
Patients receive spinal injection Bupivacaine/Morphine
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Spinal injection bupivacaine/morphine in laparoscopic surgery
Other Names:
|
Placebo Comparator: Subcutaneum injection
Placebo subcutaneum injections
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placebo injection
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of hospital stay
Time Frame: first 48 hours
|
first 48 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
use of piritramide by PCIA-pump in mg
Time Frame: 48 hours
|
48 hours
|
patient-satisfactory on a 4-point scale
Time Frame: 120 hours/ 5 days
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120 hours/ 5 days
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the occurence of side-effects (nausea, pruritus, drowsiness)
Time Frame: 120 hours/ 5 days
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120 hours/ 5 days
|
time to mobilisation
Time Frame: 120 hours/ 5 days
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120 hours/ 5 days
|
time to bowel movement
Time Frame: 120 hours/ 5 days
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120 hours/ 5 days
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abdominal compliance during laparoscopy in L/mmHg
Time Frame: The compliance will be measured for the duration of the surgery, an expected average of 2 hours.
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The compliance will be measured for the duration of the surgery, an expected average of 2 hours.
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Difficulty of surgery
Time Frame: The difficulty of surgery will be measured for the duration of the surgery, an expected average of 2 hours
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The difficulty of surgery will be measured for the duration of the surgery, an expected average of 2 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: AartJan JW Teunissen, MD, Maasstad Hospital
- Principal Investigator: Mark V Koning, MD, Maasstad Hospital
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
- Bupivacaine
- Morphine
Other Study ID Numbers
- NL43488.101.13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Spinal injection bupivacaine/morphine
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