Laparoscopic-guided TAP Block vs Epidural Analgesia

NCT05214261 | Unknown

• 1 other identifier: 112/2021
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Overall operating theatre time

  Up to 10 hours

• Post-operative morphine milligram equivalents recruitments

  Up to 1 month

• Visual analogue scale

  Up to 1 month

• Overall benefit of analgesia score (OBAS)

  Up to 1 month

• Hospital readmission

  30 and 90-day

Study Arms (2)

TAP block group

EXPERIMENTAL

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

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

Epidural analgesia group

ACTIVE COMPARATOR

Patients undergo epidural catheters placement for laparoscopic colorectal surgery

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

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oulu University Hospital: lead

Study Sites (1)

Surgery and Intensive Care Research Unit

Oulu, 90220, Finland

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Safety; Analgesia, Epidural

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Accident Prevention; Accidents; Public Health; Environment and Public Health; Analgesia; Anesthesia and Analgesia

Study Officials

• Heikki Huhta, PhD

  Oulu University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heikki Huhta, PhD

CONTACT

+3583152011; heikki.huhta@ppshp.fi

Jukka Rintala, PhD

CONTACT

+3583152011; jukka.rintala@ppshp.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastointestinal Surgeon, Adjunct Professor

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: January 28, 2022
• Study Start: February 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)