Laparoscopic-guided TAP Block vs Epidural Analgesia

NCT ID: NCT05214261

Last Updated: 2022-01-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2025-12-31

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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAP block group

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Epidural analgesia group

Patients undergo epidural catheters placement for laparoscopic colorectal surgery

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oulu University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Heikki Huhta

Gastointestinal Surgeon, Adjunct Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heikki Huhta, PhD

Role: PRINCIPAL_INVESTIGATOR

Oulu University Hospital

Locations

Surgery and Intensive Care Research Unit

Oulu, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Heikki Huhta, PhD

Role: CONTACT

heikki.huhta@ppshp.fi

+3583152011

Jukka Rintala, PhD

Role: CONTACT

jukka.rintala@ppshp.fi

+3583152011

Facility Contacts

Heikki Huhta, PhD

Role: primary

heikki.huhta@ppshp.fi

+3583152011

Jukka Rintala, PhD

Role: backup

jukka.rintala@ppshp.fi

+3583152011

Other Identifiers

112/2021

Identifier Type: -

Identifier Source: org_study_id