Clinical trial NCT05276908: 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
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Total morphine consumption in the first 24 hours postoperative
timeFrame: 24 hours
Secondary outcomes:
measure: Time to first rescue analgesia
timeFrame: 24 hours
measure: Numeric Pain Rating Scale
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy
Study officials:
affiliation: Cairo University
name: Bassant Abdelhamid
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.