Different Volumes of Local Anesthetics in Thoracolumbar Interfascial Plane Block
- Conditions
- Postoperative Pain
- Interventions
- Procedure: Thoracolumbar interfascial plane block (TLIP)TechniqueProcedure: Anesthetic Management
- Registration Number
- NCT05276908
- Lead Sponsor
- Cairo University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
-
● 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.
-
● 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mTLIP20 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). mTLIP20 Anesthetic Management 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). mTLIP10 Thoracolumbar interfascial plane block (TLIP)Technique 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). mTLIP10 Anesthetic Management 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). mTLIP10 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 Thoracolumbar interfascial plane block (TLIP)Technique 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 Measures
Name Time Method Total morphine consumption in the first 24 hours postoperative 24 hours
- Secondary Outcome Measures
Name Time Method Numeric Pain Rating Scale 24 hours 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 to first rescue analgesia 24 hours measured from time of block administration to time of rescue analgesia administration
Trial Locations
- Locations (1)
Kasr Alainy
🇪🇬Cairo, Egypt