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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
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.
Surgery and Intensive Care Research Unit
Oulu, Finland
RECRUITINGLength 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
Time frame: Up to 1 month
Overall operating theatre time
Overall operating theatre time
Time frame: Up to 10 hours
Post-operative morphine milligram equivalents recruitments
Post-operative morphine recruiments
Time frame: Up to 1 month
Visual analogue scale
The scores range 1 to 10. Higher scores indicates worse outcome in the treatment of anelgesia.
Time frame: Up to 1 month
Overall benefit of analgesia score (OBAS)
The scores range 0 - 24. Low OBAS socre indicates high benefit of analgesia
Time frame: Up to 1 month
Hospital readmission
Post-operative readmissions
Time frame: 30 and 90-day
Time to first flatus
Post-operative flatus
Time frame: Up to 1 month
Time to first bowel movement
Post-operative bowel movement
Time frame: Up to 1 month
Time to post-operative mobilization
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Post-operative mobilization
Time frame: Up to 1 month
Overall cost-effectiveness
Overall cost-effectiveness
Time frame: Up to 6 months
Post-operative complications related to interventions according to Clavien-Dindo classification
Post-operative complications
Time frame: 30 and 90-day