Spinal Bupivacaine/Morphine in Laparoscopic Gastro-intestinal Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Spinal Bupivacaine/Morphine in Laparoscopic Gastro-intestinal Surgery

Conditions
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Spinal Bupivacaine/Morphine in Laparoscopic Surgery

Intervention / Treatment
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* Drug: Spinal injection bupivacaine/morphine
* Drug: subcutaneum injection lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Laparoscopic Gastro-intestinal surgery Exclusion Criteria: Bariatric surgery, gastric surgery, rectal surgery, kidney failure, aorta-valve stenosis, coagulation disorders, emergency surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spinal injection<br>Patients receive spinal injection Bupivacaine/Morphine | Drug: Spinal injection bupivacaine/morphine<br>* Spinal injection bupivacaine/morphine in laparoscopic surgery<br>* Other names: injection;|
| Placebo Comparator: Subcutaneum injection<br>Placebo subcutaneum injections | Drug: subcutaneum injection lidocaine<br>* placebo injection<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospital stay |  | first 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| use of piritramide by PCIA-pump in mg |  | 48 hours | 
| 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 | 
| time to bowel movement |  | 120 hours/ 5 days | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Morphine, Laparoscopic GI-surgery, Post-operative pain