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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05214261
Other study ID # 112/2021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2022
Est. completion date December 31, 2025

Study information

Verified date January 2022
Source Oulu University Hospital
Contact Heikki Huhta, PhD
Phone +3583152011
Email heikki.huhta@ppshp.fi
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The LAPTAP trial will provide evidence on preferred post-operative analgesia method in elective laparoscopic colon surgery.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 210
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility IInclusion criteria - Patients who undergo elective laparoscopic colorectal surgery for colorectal neoplasia, diverticulitis, and other diseases of the colon and rectosigmal area - Patients able to provide informed written consent - Patients capable of completing questionnaires at the time of consent Exclusion criteria - Documented allergic reaction to morphine, hydromorphone, lidocaine, bupivacaine, fentanyl and/or oxycodone - Contra-indication to placement of epidural catheter (spinal stenosis, spinal fusion, elevated international normal ratio (INR), anticoagulation, patient refusal, etc.) or TAP block (patient refusal) - Urgent or emergent surgery precluding epidural catheter placement or TAP block - Systemic Infection contraindicating epidural catheter placement or TAP block - Rectal surgery - Pregnant or suspected pregnancy - Age < 18 years - Planned open surgery - Planned bowel stoma (protective diversion and/or permanent stoma) - Unwillingness to participate in follow-up assessments - Patients with severe chronic pain - Known sensibility for opioid side effects - i.v.-PCA is contraindicated (for example drug abuse) - No informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Safety and efficiency of post operative analgesia between laparoscopic-assisted TAP block and epidural analgesia
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.

Locations

Country Name City State
Finland Surgery and Intensive Care Research Unit Oulu

Sponsors (1)

Lead Sponsor Collaborator
Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Overall operating theatre time Overall operating theatre time Up to 10 hours
Secondary Post-operative morphine milligram equivalents recruitments Post-operative morphine recruiments Up to 1 month
Secondary Visual analogue scale The scores range 1 to 10. Higher scores indicates worse outcome in the treatment of anelgesia. Up to 1 month
Secondary Overall benefit of analgesia score (OBAS) The scores range 0 - 24. Low OBAS socre indicates high benefit of analgesia Up to 1 month
Secondary Hospital readmission Post-operative readmissions 30 and 90-day
Secondary Time to first flatus Post-operative flatus Up to 1 month
Secondary Time to first bowel movement Post-operative bowel movement Up to 1 month
Secondary Time to post-operative mobilization Post-operative mobilization Up to 1 month
Secondary Overall cost-effectiveness Overall cost-effectiveness Up to 6 months
Secondary Post-operative complications related to interventions according to Clavien-Dindo classification Post-operative complications 30 and 90-day
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