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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal injection | Active Comparator | Patients receive spinal injection Bupivacaine/Morphine |
|
| Subcutaneum injection | Placebo Comparator | Placebo subcutaneum injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal injection bupivacaine/morphine | Drug | Spinal injection bupivacaine/morphine in laparoscopic surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of hospital stay | first 48 hours |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AartJan JW Teunissen, MD | Maasstad Hospital | Principal Investigator |
| Mark V Koning, MD | Maasstad Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maasstad Hospital | Rotterdam | 3079DZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29219935 | Background | Koning MV, Teunissen AJW, van der Harst E, Ruijgrok EJ, Stolker RJ. Intrathecal Morphine for Laparoscopic Segmental Colonic Resection as Part of an Enhanced Recovery Protocol: A Randomized Controlled Trial. Reg Anesth Pain Med. 2018 Feb;43(2):166-173. doi: 10.1097/AAP.0000000000000703. |
| Label | URL |
|---|---|
| Full text | View source |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| D007267 | Injections |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| subcutaneum injection lidocaine | Drug | placebo injection |
|
|
| 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 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |