TAP ALIF: Echo-guided Transverse Abdominal Plane Block (TAP) in Anterior Lumbar Arthrodesis (ALIF)

Sponsor
Clinique Saint Jean, France (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06002217
Collaborator
(none)
80
2
6.2

Study Details

Study Description

Brief Summary

The goal of this interventional study is to is to compare the effect of a tap block versus a placebo in patients undergoing anterior lumbar spine surgery.

The main question it aims to answer :

• whether tap block can reduce the need for postoperative pain medication Participants will be randomized into two groups and all postoperative pain medication will be recorded over 3 days.

Researchers will compare tap block vs placebo to see if it reduces postoperative pain.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Echo-guided Transverse Abdominal Plane Block (TAP) in Anterior Lumbar Arthrodesis (ALIF): Randomized, Double-blind, Controlled Trial.
Anticipated Study Start Date :
Aug 22, 2023
Anticipated Primary Completion Date :
Feb 28, 2024
Anticipated Study Completion Date :
Feb 28, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: TAP Block

Drug: Levobupivacaine
Patients in the tap block arm will receive an injection of levobupivacaine 2.5mg/ml

Placebo Comparator: saline solution

Other: Placebo Tap block
Patients in the placebo arm will receive an injection of salin solution 2.5mg/ml , in the same way as tap block

Outcome Measures

Primary Outcome Measures

  1. Analgesic consumption [72hours]

    The use of analgesics (oral or venous) during the during the 72 hours following surgery

Secondary Outcome Measures

  1. Pain assessment will be reported for 72 hours after surgery measured on a Visual analogue scale between 0 and 10 [72hours]

    Pain assessment for 72 hours after surgery, measured on a scale between 0 and 10 (VAS scale ), where 0 is no pain and 10 is maximum pain

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Patient affiliated or entitled to a social security plan.

  • Patient who has been informed about the study and has co-signed a consent form with the investigator. consent to participate in the study.

  • Patients over 18 years of age scheduled for abdominal disc surgery on one or two levels.

  • Patient with ASA criteria 1, 2 and 3.

Exclusion Criteria:
  • Patients with intolerance or contraindication to paracetamol, anti-inflammatory or morphine.

  • Patients allergic to local anesthetics.

  • Pregnant or breast-feeding patient.

  • patient undergoing cancer or trauma surgery trauma.

  • Patient participating in another interventional study.

  • Patient with a history of lumbar arthrodesis.

  • Patient refusing to sign consent form.

  • Patient unable to give informed consent.

  • Patient under court protection, guardianship or trusteeship.

  • Patient not available for study follow-up.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Clinique Saint Jean, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guillaume LONJON, Principal investigator, Clinique Saint Jean, France
ClinicalTrials.gov Identifier:
NCT06002217
Other Study ID Numbers:
  • 2022-A00970-43
First Posted:
Aug 21, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2023