Different Volumes of Local Anesthetics in Thoracolumbar Interfascial Plane Block
NCT ID: NCT05276908
Last Updated: 2022-12-19
Study Results
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Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2022-03-03
2022-12-03
Brief Summary
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There are limited number of studies investigating the analgesic efficacy of mTLIP block however, no previous study has demonstrated the ideal local anesthetic volume for this block in lumber spine surgery. Moreover, this technique is considered new regional anesthetic techniques and so both of them should be involved in further studies, on the other hand the comparison between both of them at the same study wasn't discussed before, and so we will proceed at this study.
Detailed Description
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Prospective randomized double blinded study The study will be conducted in Kasr Alainy hospital orthopedic surgical theater. Adult patients undergoing lumbar spine surgeries involving 1 up to 3 adjacent lumbar vertebrae (eg. laminectomy, discectomy …). at Kasr Alainy hospital.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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mTLIP10
patients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 20 ml 0.25%bupivacaine (10 ml on each side).
Thoracolumbar interfascial plane block (TLIP)Technique
A curvilinear array ultrasound probe (Siemens ACUSON X300 Ultrasound System) will be placed at the targeted lumbar level.The corresponding spinous process and interspinal muscles will be identified, and the probe will be slided laterally to identify the longissimus muscle and iliocostalis muscle. Under ultrasound guidance, A 38-mm 22-gauge (22-G, 50-mm 'Stimuplex; BBraun, Melsung, Germany) regional block needle will be advanced in plane to the ultrasound beam in a medial to lateral orientation through the belly of longissimus muscle toward the iliocostalis muscle. Hydro-dissection with 2-3 ml of isotonic saline solution will confirm the correct needle tip position and, after negative aspiration, 0.25 % bupivacaine will be injected slowly whilst carefully monitoring the spread of local anesthetic into the fascial plane between the longissimus and iliocostalis muscles. The same procedure will be repeated on the contralateral side.
Anesthetic Management
Induction:
Induction of general anesthesia will be performed using a regimen of IV 2 μg/kg fentanyl and propofol IV 2 mg /kg. Tracheal intubation will be facilitated using 0.5 mg/kg IV of atracurium.
Maintenance:
Anesthesia will be maintained with inhaled isoflurane 0.8% in oxygen enriched air (FiO2=0.5). Maintenance doses of 0.1 m\\kg atracurium will be provided every 30 minutes. Then the patient will be placed in prone position.
Bupivacaine Injection 10ml
patients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 20 ml 0.25%bupivacaine (10 ml on each side).
mTLIP20
patients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 40 ml 0.25%bupivacaine (20 ml on each side).
Thoracolumbar interfascial plane block (TLIP)Technique
A curvilinear array ultrasound probe (Siemens ACUSON X300 Ultrasound System) will be placed at the targeted lumbar level.The corresponding spinous process and interspinal muscles will be identified, and the probe will be slided laterally to identify the longissimus muscle and iliocostalis muscle. Under ultrasound guidance, A 38-mm 22-gauge (22-G, 50-mm 'Stimuplex; BBraun, Melsung, Germany) regional block needle will be advanced in plane to the ultrasound beam in a medial to lateral orientation through the belly of longissimus muscle toward the iliocostalis muscle. Hydro-dissection with 2-3 ml of isotonic saline solution will confirm the correct needle tip position and, after negative aspiration, 0.25 % bupivacaine will be injected slowly whilst carefully monitoring the spread of local anesthetic into the fascial plane between the longissimus and iliocostalis muscles. The same procedure will be repeated on the contralateral side.
Anesthetic Management
Induction:
Induction of general anesthesia will be performed using a regimen of IV 2 μg/kg fentanyl and propofol IV 2 mg /kg. Tracheal intubation will be facilitated using 0.5 mg/kg IV of atracurium.
Maintenance:
Anesthesia will be maintained with inhaled isoflurane 0.8% in oxygen enriched air (FiO2=0.5). Maintenance doses of 0.1 m\\kg atracurium will be provided every 30 minutes. Then the patient will be placed in prone position.
Bupivacaine Injection 20ml
patients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 40 ml 0.25%bupivacaine (20 ml on each side).
Interventions
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Thoracolumbar interfascial plane block (TLIP)Technique
A curvilinear array ultrasound probe (Siemens ACUSON X300 Ultrasound System) will be placed at the targeted lumbar level.The corresponding spinous process and interspinal muscles will be identified, and the probe will be slided laterally to identify the longissimus muscle and iliocostalis muscle. Under ultrasound guidance, A 38-mm 22-gauge (22-G, 50-mm 'Stimuplex; BBraun, Melsung, Germany) regional block needle will be advanced in plane to the ultrasound beam in a medial to lateral orientation through the belly of longissimus muscle toward the iliocostalis muscle. Hydro-dissection with 2-3 ml of isotonic saline solution will confirm the correct needle tip position and, after negative aspiration, 0.25 % bupivacaine will be injected slowly whilst carefully monitoring the spread of local anesthetic into the fascial plane between the longissimus and iliocostalis muscles. The same procedure will be repeated on the contralateral side.
Anesthetic Management
Induction:
Induction of general anesthesia will be performed using a regimen of IV 2 μg/kg fentanyl and propofol IV 2 mg /kg. Tracheal intubation will be facilitated using 0.5 mg/kg IV of atracurium.
Maintenance:
Anesthesia will be maintained with inhaled isoflurane 0.8% in oxygen enriched air (FiO2=0.5). Maintenance doses of 0.1 m\\kg atracurium will be provided every 30 minutes. Then the patient will be placed in prone position.
Bupivacaine Injection 10ml
patients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 20 ml 0.25%bupivacaine (10 ml on each side).
Bupivacaine Injection 20ml
patients will receive single shot of bilateral modified thoracolumbar interfascial plane block at the mid-level of the operative intervention with 40 ml 0.25%bupivacaine (20 ml on each side).
Eligibility Criteria
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Inclusion Criteria
* Type of surgery: lumbar spine surgeries involving 1 up to 3 adjacent lumbar vertebrae
* Physical status ASA I, II.
* Age 18 to 65 Years.
* Body mass index (BMI): \> 20 kg/m2 and \< 35 kg/m2.
Exclusion Criteria
* Patients with history of previous surgical operations in the lumbar region.
* Patients with spinal deformities (eg. Scoliosis…..).
* Hypersensitivity to Bupivacaine.
* Extensive Lumbar spine surgeries like large tumor excisions, scoliosis correction or more than 2 level spine fixations.
* Patients with communication difficulties.
* Lumbar spine operations that will be performed with the patient in any position other than the prone position.
* Severe neurological compromise (severe muscle weakness such as foot drop or sphincter disorders such as urinary incontinence).
18 Years
65 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Bassant M. Abdelhamid
Assissnt professor
Principal Investigators
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Bassant Abdelhamid
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
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Kasr Alainy
Cairo, , Egypt
Countries
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References
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Ammar MA, Taeimah M. Evaluation of thoracolumbar interfascial plane block for postoperative analgesia after herniated lumbar disc surgery: A randomized clinical trial. Saudi J Anaesth. 2018 Oct-Dec;12(4):559-564. doi: 10.4103/sja.SJA_177_18.
Li C, Jia J, Qin Z, Tang Z. The use of ultrasound-guided modified thoracolumbar interfascial plane (TLIP) block for multi-level lumbar spinal surgery. J Clin Anesth. 2018 May;46:49-51. doi: 10.1016/j.jclinane.2018.01.018. Epub 2018 Mar 26. No abstract available.
Abdelhamid B, Ayman E, Nabil T, Hamimy WI, El-Monem Morsy MA. Analgesic efficacy of two different volumes of local anaesthetics in ultrasound-guided modified approach to the thoracolumbar interfascial plane block in patients undergoing lumbar spine surgeries: a randomized controlled trial. Anaesthesiol Intensive Ther. 2023;55(5):358-365. doi: 10.5114/ait.2023.134196.
Other Identifiers
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MD-307-2020
Identifier Type: -
Identifier Source: org_study_id