CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 34 enrolled
Drug / intervention
I.V drug based multimodal approach +1 moredrug
Likely dose
I.V drug based multimodal approach 5mgfrom record
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Search/NCT03193658
NCT03193658N/ACompleted

Effect of Ultrasound Guided Bilateral Thoracolumbar Interfascial Plane (TLIP) Block on Post-operative Opioid Consumption After Lumbar Spine Surgeries. A Randomized Double Blinded Study.

Eslam Ayman Mohamed Shawki·interventional·Posted Jun 21, 2017·Updated Oct 4, 2018

In Brief

A clinical study evaluating Thoracolumbar Interfascial Plane (TLIP) block and I.V drug based multimodal approach for Regional Anesthesia. Completed, enrolled 34 participants across 1 site.

Detailed Summary

The study aims to evaluate the effect of US guided bilateral Thoracolumbar Interfascial plane (TLIP) block performed at the level of the lumbar spine surgery (involving 1 up to 3 adjacent lumbar vertebrae) after induction of general anesthesia and before starting the surgery on postoperative opioid consumption by the patients during the first 24 hours postoperative.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJun 21, 2017
Enrollment StartAug 1, 2017
Primary CompletionJul 1, 2018
Study CompletionAug 1, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 9.0 years ago

Interventions

Thoracolumbar Interfascial Plane (TLIP) blockprocedure

A 10 cm 21G Stimuplex needle (Braun Medical Inc, Bethlehem, PA, USA) will be inserted in a lateral-to-medial orientation with an approximate angle of 30 degrees to the skin. The needle will then be advanced under real-time in-plane ultrasound guidance through the belly of the LG towards the MF. The needle tip will be directed towards the LG/MF interface deep to the midpoint then a total volume of 20 ml of Bupivacaine 0.25% will be incrementally injected with intermittently repeated negative aspiration. Anterior spread of local anesthetic will be viewed as favourable. The same procedure will be repeated on the left side. The patient will then be disinfected and draped and surgery will be allowed to proceed normally.

I.V drug based multimodal approachdrug

A base low dose opioid of 5mg morphine I.V every 8 hours. Rescue analgesia will be given to the patient if reported a VAS equal or more than 4 in the form of I.V morphine in 2.5mg increments till VAS returns to 4 or less in addition to 1 gm of oral acetaminophen every 6 hours