Laparoscopic-guided TAP Block vs Epidural Analgesia

Laparoscopic-Guided Transversus Abdominis Plane Block Versus Epidural Analgesia in a Colorectal Laparoscopic Surgery. A Protocol for a Randomized Clinical Trial

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

Study Overview

• Status: Recruiting
• Conditions: Post Operative Pain
• Intervention / Treatment: Other: Safety and efficiency of post operative analgesia between laparoscopic-assisted TAP block and epidural analgesia

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.

• Study Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heikki Huhta, PhD; Phone Number: +3583152011; Email: heikki.huhta@ppshp.fi
• Study Contact Backup: Name: Jukka Rintala, PhD; Phone Number: +3583152011; Email: jukka.rintala@ppshp.fi

Study Locations

• Finland
  • Oulu, Finland, 90220
    • Recruiting
    • Surgery and Intensive Care Research Unit
    • Contact: Heikki Huhta, PhD; Phone Number: +3583152011; Email: heikki.huhta@ppshp.fi
    • Contact: Jukka Rintala, PhD; Phone Number: +3583152011; Email: jukka.rintala@ppshp.fi
    • Principal Investigator: Mari Pohjola, PhD
    • Principal Investigator: Nina Rotko, MD
    • Principal Investigator: Janne H Liisanantti, Prof
    • Principal Investigator: Tero Rautio, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAP block group; 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; 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.
Active Comparator: Epidural analgesia group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oulu University Hospital
• Investigators: Principal Investigator: Heikki Huhta, PhD, Oulu University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: November 16, 2021
• First Submitted That Met QC Criteria: January 17, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 112/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No