Different Volumes of Local Anesthetics in Thoracolumbar Interfascial Plane Block
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Thoracolumbar interfascial plane block (TLIP)Technique
Anesthetic Management
Bupivacaine Injection 10ml
Bupivacaine Injection 20ml
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
● Both gender
- 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 on preoperative opioid regimen for more than 1 month.
- 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).
Sites / Locations
- Kasr Alainy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
mTLIP10
mTLIP20
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
Total morphine consumption in the first 24 hours postoperative
Secondary Outcome Measures
Time to first rescue analgesia
measured from time of block administration to time of rescue analgesia administration
Numeric Pain Rating Scale
Pain scale of managmet when zero indicates no pain and ten indicates maximum pain both at rest and during movement: 30 minutes,2, 4,6, 8, 12, 16, 20 and 24postoperatively.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05276908
Brief Title
Different Volumes of Local Anesthetics in Thoracolumbar Interfascial Plane Block
Official Title
Analgesic Efficacy of Two Different Volumes of Local Anesthetics in Ultrasound-guided Modified Approach of Thoracolumbar Block in Patients Undergoing Lumbar Spine Surgeries; a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 3, 2022 (Actual)
Primary Completion Date
November 3, 2022 (Actual)
Study Completion Date
December 3, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Ultrasound-guided thoracolumbar interfascial plane block (TLIP)was first described in 2015 by Hand et al which also target the dorsal rami of the thoracolumbar nerves as they pass through the paraspinal musculature(between the multifidus muscle (MF) and the longissimus muscle (LG)). The block was performed bilaterally at the level of L3 and they reported a reproducible area of anesthesia to pinprick in a mean (SD) area covering 137.4 (71.0) cm2 of the lower back (including the midline) after 20 minutes of the block. This procedure has subsequently been modified by Ueshima H et al in 2016 by targeting the injection in the plane between the longissimus and iliocostalis muscles (mTLIP) which helps avoiding the spread of local anesthetics to the ventral ramus and neuraxial space, thus, the modified TLIP block is considered to be a more refined version of the original TLIP block and safer and easier to perform.
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
The aim of this study is to compare the post-operative analgesic efficacy of two different volumes of local anesthetics in bilateral modified thoracolumbar interfascial plane block in lumbar spine surgeries.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mTLIP10
Arm Type
Experimental
Arm Description
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).
Arm Title
mTLIP20
Arm Type
Experimental
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Thoracolumbar interfascial plane block (TLIP)Technique
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Anesthetic Management
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Injection 10ml
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Injection 20ml
Intervention Description
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).
Primary Outcome Measure Information:
Title
Total morphine consumption in the first 24 hours postoperative
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Time to first rescue analgesia
Description
measured from time of block administration to time of rescue analgesia administration
Time Frame
24 hours
Title
Numeric Pain Rating Scale
Description
Pain scale of managmet when zero indicates no pain and ten indicates maximum pain both at rest and during movement: 30 minutes,2, 4,6, 8, 12, 16, 20 and 24postoperatively.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
● Both gender
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 on preoperative opioid regimen for more than 1 month.
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bassant Abdelhamid
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30429737
Citation
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.
Results Reference
background
PubMed Identifier
29414616
Citation
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.
Results Reference
background
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Different Volumes of Local Anesthetics in Thoracolumbar Interfascial Plane Block
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