Clinical trial NCT05214261: Laparoscopic-guided TAP Block vs Epidural Analgesia
Official title: Laparoscopic-Guided Transversus Abdominis Plane Block Versus Epidural Analgesia in a Colorectal Laparoscopic Surgery. A Protocol for a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Oulu University Hospital
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Length of post-operative hospital stay after elective laparoscopic colorectal surgery.
timeFrame: Up to 1 month
Secondary outcomes:
measure: Overall operating theatre time
timeFrame: Up to 10 hours
measure: Post-operative morphine milligram equivalents recruitments
timeFrame: Up to 1 month
measure: Visual analogue scale
timeFrame: Up to 1 month
measure: Overall benefit of analgesia score (OBAS)
timeFrame: Up to 1 month
measure: Hospital readmission
timeFrame: 30 and 90-day
measure: Time to first flatus
timeFrame: Up to 1 month
measure: Time to first bowel movement
timeFrame: Up to 1 month
measure: Time to post-operative mobilization
timeFrame: Up to 1 month
measure: Overall cost-effectiveness
timeFrame: Up to 6 months
measure: Post-operative complications related to interventions according to Clavien-Dindo classification
timeFrame: 30 and 90-day
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Surgery and Intensive Care Research Unit
Study officials:
affiliation: Oulu University Hospital
name: Heikki Huhta, PhD
role: PRINCIPAL_INVESTIGATOR
References: