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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinique Saint Jean, France

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Levobupivacaine

    Drug

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

  • Placebo Tap block

    Other intervention

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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: TAP BlockActive comparator 1 intervention
Group B: saline solutionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Analgesic consumption

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

Time frame
72hours

Secondary outcomes

1

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

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

Time frame
72hours

Other outcomes

Sponsors and contacts

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