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The LAPTAP trial will provide evidence on preferred post-operative analgesia method in elective laparoscopic colon surgery.
In most previous studies TAP-block has been inserted by anesthesiologist under ultrasound guidance. TAP blockade can alternatively be performed by a surgeon with laparoscopic visual guidance during trocar placement by aiming injection into fascial plane between the internal oblique and transversus abdominis in the midaxillary line and repeated on the contralateral side. There is lack in studies comparing laparoscopic guided TAP-blockade versus epidural pain analgesia in elective laparoscopic colon surgery exist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAP block group | Experimental | Patiens undergo laparoscopic-guided TAP block installation for laparoscopic clolorectal surgery |
|
| Epidural analgesia group | Active Comparator | Patients undergo epidural catheters placement for laparoscopic colorectal surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Safety and efficiency of post operative analgesia between laparoscopic-assisted TAP block and epidural analgesia | Other | Patients in the TAP group will be given a laparoscopic-assisted TAP block with a total of 2mg/kg of 0.25% bupivacaine in the bilateral subcostal region into four spots of the bilateral subcostal region, two on both sides of the lateral abdomen between the anterior iliac spine and lower costal arch. The TAP block is performed after the first trocar placement before the insertion of other trocars and the beginning of the surgical intervention. In the control group epidural catheters will be placed using landmark- and loss-of-resistance techniques while the patient is on the operating table. Infusions of 4ml/h containing 0.125% levobupivacaine and 5.5 μg/mL fentanyl will be started with a CADD Solis VIP-infusion pump at the time of anesthesia induction. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of post-operative hospital stay after elective laparoscopic colorectal surgery. | The primary endpoint in this study is the length of post-operative hospital stay after elective laparoscopic colorectal surgery | Up to 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Overall operating theatre time | Overall operating theatre time | Up to 10 hours |
| Post-operative morphine milligram equivalents recruitments | Post-operative morphine recruiments |
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IInclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heikki Huhta, PhD | Contact | +3583152011 | heikki.huhta@ppshp.fi | |
| Jukka Rintala, PhD | Contact | +3583152011 | jukka.rintala@ppshp.fi |
| Name | Affiliation | Role |
|---|---|---|
| Heikki Huhta, PhD | Oulu University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surgery and Intensive Care Research Unit | Recruiting | Oulu | 90220 | Finland |
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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 |
|---|---|
| D012449 | Safety |
| D015360 | Analgesia, Epidural |
| ID | Term |
|---|---|
| D000056 | Accident Prevention |
| D000059 | Accidents |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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|
| Up to 1 month |
| Visual analogue scale | The scores range 1 to 10. Higher scores indicates worse outcome in the treatment of anelgesia. | Up to 1 month |
| Overall benefit of analgesia score (OBAS) | The scores range 0 - 24. Low OBAS socre indicates high benefit of analgesia | Up to 1 month |
| Hospital readmission | Post-operative readmissions | 30 and 90-day |
| Time to first flatus | Post-operative flatus | Up to 1 month |
| Time to first bowel movement | Post-operative bowel movement | Up to 1 month |
| Time to post-operative mobilization | Post-operative mobilization | Up to 1 month |
| Overall cost-effectiveness | Overall cost-effectiveness | Up to 6 months |
| Post-operative complications related to interventions according to Clavien-Dindo classification | Post-operative complications | 30 and 90-day |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |