Laparoscopic-guided TAP Block vs Epidural Analgesia

Oulu University Hospital

Status: Enrolling

Conditions: Post Operative Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05214261

112/2021

Details and patient eligibility

About

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

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

TAP block group

Experimental group

Description:

Patiens undergo laparoscopic-guided TAP block installation for laparoscopic clolorectal surgery

Treatment:

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

Epidural analgesia group

Active Comparator group

Description:

Patients undergo epidural catheters placement for laparoscopic colorectal surgery

Treatment:

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