Spinal Bupivacaine/Morphine in Laparoscopic Surgery
Conditions
Keywords
Spinal Morphine, Laparoscopic GI-surgery, Post-operative pain
Brief summary
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.
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.
Interventions
DRUGSpinal injection bupivacaine/morphine
Spinal injection bupivacaine/morphine in laparoscopic surgery
DRUGsubcutaneum injection lidocaine
placebo injection
Sponsors
Maasstad Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Laparoscopic Gastro-intestinal surgery
Exclusion criteria
* Bariatric surgery, gastric surgery, rectal surgery, kidney failure, aorta-valve stenosis, coagulation disorders, emergency surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of hospital stay | first 48 hours |
Secondary
| Measure | Time frame |
|---|---|
| patient-satisfactory on a 4-point scale | 120 hours/ 5 days |
| the occurence of side-effects (nausea, pruritus, drowsiness) | 120 hours/ 5 days |
| time to mobilisation | 120 hours/ 5 days |
| use of piritramide by PCIA-pump in mg | 48 hours |
| abdominal compliance during laparoscopy in L/mmHg | The compliance will be measured for the duration of the surgery, an expected average of 2 hours. |
| Difficulty of surgery | The difficulty of surgery will be measured for the duration of the surgery, an expected average of 2 hours |
| time to bowel movement | 120 hours/ 5 days |
Countries
Netherlands
Outcome results
None listed