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Laparoscopic-guided TAP Block vs Epidural Analgesia

Primary Purpose

Post Operative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Safety and efficiency of post operative analgesia between laparoscopic-assisted TAP block and epidural analgesia
Sponsored by
Oulu University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Surgery and Intensive Care Research UnitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TAP block group

Epidural analgesia group

Arm Description

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

Patients undergo epidural catheters placement for laparoscopic colorectal surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 16, 2021
Last Updated
January 17, 2022
Sponsor
Oulu University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05214261
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oulu University Hospital

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAP block group
Arm Type
Experimental
Arm Description
Patiens undergo laparoscopic-guided TAP block installation for laparoscopic clolorectal surgery
Arm Title
Epidural analgesia group
Arm Type
Active Comparator
Arm Description
Patients undergo epidural catheters placement for laparoscopic colorectal surgery
Intervention Type
Other
Intervention Name(s)
Safety and efficiency of post operative analgesia between laparoscopic-assisted TAP block and epidural analgesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Length of post-operative hospital stay after elective laparoscopic colorectal surgery.
Description
The primary endpoint in this study is the length of post-operative hospital stay after elective laparoscopic colorectal surgery
Time Frame
Up to 1 month
Secondary Outcome Measure Information:
Title
Overall operating theatre time
Description
Overall operating theatre time
Time Frame
Up to 10 hours
Title
Post-operative morphine milligram equivalents recruitments
Description
Post-operative morphine recruiments
Time Frame
Up to 1 month
Title
Visual analogue scale
Description
The scores range 1 to 10. Higher scores indicates worse outcome in the treatment of anelgesia.
Time Frame
Up to 1 month
Title
Overall benefit of analgesia score (OBAS)
Description
The scores range 0 - 24. Low OBAS socre indicates high benefit of analgesia
Time Frame
Up to 1 month
Title
Hospital readmission
Description
Post-operative readmissions
Time Frame
30 and 90-day
Title
Time to first flatus
Description
Post-operative flatus
Time Frame
Up to 1 month
Title
Time to first bowel movement
Description
Post-operative bowel movement
Time Frame
Up to 1 month
Title
Time to post-operative mobilization
Description
Post-operative mobilization
Time Frame
Up to 1 month
Title
Overall cost-effectiveness
Description
Overall cost-effectiveness
Time Frame
Up to 6 months
Title
Post-operative complications related to interventions according to Clavien-Dindo classification
Description
Post-operative complications
Time Frame
30 and 90-day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heikki Huhta, PhD
Phone
+3583152011
Email
heikki.huhta@ppshp.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Jukka Rintala, PhD
Phone
+3583152011
Email
jukka.rintala@ppshp.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heikki Huhta, PhD
Organizational Affiliation
Oulu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Surgery and Intensive Care Research Unit
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heikki Huhta, PhD
Phone
+3583152011
Email
heikki.huhta@ppshp.fi
First Name & Middle Initial & Last Name & Degree
Jukka Rintala, PhD
Phone
+3583152011
Email
jukka.rintala@ppshp.fi
First Name & Middle Initial & Last Name & Degree
Mari Pohjola, PhD
First Name & Middle Initial & Last Name & Degree
Nina Rotko, MD
First Name & Middle Initial & Last Name & Degree
Janne H Liisanantti, Prof
First Name & Middle Initial & Last Name & Degree
Tero Rautio, Prof

12. IPD Sharing Statement

Plan to Share IPD
No

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Laparoscopic-guided TAP Block vs Epidural Analgesia

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