USG Thoracolumbar Interfascial Plane (TLIP) in Lumbar Spine Surgeries
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|ClinicalTrials.gov Identifier: NCT03193658|
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : October 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Regional Anesthesia||Procedure: Thoracolumbar Interfascial Plane (TLIP) block Drug: I.V drug based multimodal approach||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled double blinded study|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effect of Ultrasound Guided Bilateral Thoracolumbar Interfascial Plane (TLIP) Block on Post-operative Opioid Consumption After Lumbar Spine Surgeries. A Randomized Double Blinded Study.|
|Actual Study Start Date :||August 1, 2017|
|Actual Primary Completion Date :||July 1, 2018|
|Actual Study Completion Date :||August 1, 2018|
Active Comparator: Group T
Will receive bilateral US guided Thoracolumbar Interfascial Plane (TLIP) block at the proposed level of surgery before the start of the surgery
Procedure: Thoracolumbar Interfascial Plane (TLIP) block
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.
Active Comparator: Group O
Will not receive the block and postoperative pain control will be managed by I.V drug based multi-modal approach (Opioid & acetaminophen) only.
Drug: I.V drug based multimodal approach
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
- Total morphine consumption in the first 24 hours postoperative [ Time Frame: 24 hours postoperative ]Total morphine consumption in the first 24 hours postoperative (Above the basal 15mg given to all patients) as an indicator of technique efficiency in improving postoperative analgesia.
- Time required to perform the technique [ Time Frame: 30 minutes ]Time required to perform the technique (time between the start of US scanning and injection of the second local anesthetic bolus).
- Time of the operation [ Time Frame: 4 hours ]Time of the operation (time between induction of anesthesia and full recovery of the patient)
- Total intraoperative I.V. fentanyl dose [ Time Frame: 4 hours ]Total intraoperative I.V. fentanyl dose (above the standard 2µg/kg).
- VAS value after recovery [ Time Frame: 4 hours ]VAS value obtained from patient immediately after recovery from anesthesia then every 4 hours during the first 24 hours postoperatively.
- Modified Bromage score value after recovery [ Time Frame: 4 hours ]Modified Bromage score value in the lower limbs obtained immediately after recovery from anesthesia then every 4 hours during the first 24 hours postoperatively.
- First time of rescue analgesia [ Time Frame: 24 hours ]First time of rescue analgesia
- Incidence of side effects related to opioid use [ Time Frame: 24 hours ]Incidence of side effects related to opioid use (postoperative nausea and vomiting (PONV), constipation, pruritus, urinary retention…..).
- Incidence of complications or side-effects related to the block [ Time Frame: 24 hours ]Incidence of complications or side-effects related to the block (hematoma formation or intravascular injection).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193658
|Faculty of medicine, Cairo University teaching hospitals (Kasr Alainy)|