Spondylolisthesis Clinical Trial
Official title:
A Randomized, Double Blind, Placebo Controlled Evaluation Trial of the Benefit in Quadratus Lumborum Block as a Postoperative Analgesic Technique for a Lumbar Spine Decompression and Fusion Surgery
Lumbar spinal decompression and fusion is a commonly performed procedure fro neural
impingement and back pain from a variety of pathologies. The importance of pain control in
the postoperative period for spinal surgery has been discussed and proven extensively, with
both immediate and delayed reduction in complications and improved clinical results.
Quadratus lumborum (QL) block was introduced in 2007 and is performed under ultrasound
guidance for perioperative pain management in various surgeries.However, the plane for a
posterior QL block can be easily reached during open midline spinal surgery.
The investigators hypothesize that the posterior QL block is an effective analgesic tool for
lumbar laminectomy surgery, because in lumbar laminectomy the quadratus lumborum is already
exposed and is in direct visual contact. For that reason it is imperative to test the
benefits of this procedure.
This is a double blinded randomized control study to assess the results of intra-operative QL
block performed for lumbar decompression and fusion.
Spinal decompression is a surgical procedure that is performed to alleviate pain caused by
pinched nerves (neural impingement). Surgical options for decompressing the lumbar spine vary
from minimally invasive disc decompression to open laminectomy and foraminotomy. The lumbar
spine decompression and fusion differs from a microdiscectomy in that the incision is longer
and there is more muscle stripping. Lumbar spinal decompression is a commonly performed
procedure and the conventional open techniques of decompression remain the gold standard of
treatment.
During a lumbar decompression back surgery, a small portion of the bone over the nerve root
and/or disc material from under the nerve root is removed to give the nerve root more space
and provide a better healing environment. A lumbar spine decompression and fusion is
typically performed to relieve the lumbar spinal stenosis symptoms. The goal of the surgery
is to allow more space for the nerve root, thus reducing pain (and potentially any leg
weakness or neurological symptoms) and restoring the patient's ability to participate in
everyday activities[1].
Quadratus lumborum (QL) block was introduced in 2007 and is performed for perioperative pain
management in various abdominal, pelvic, gynecological and hip procedures in all age
groups[2]. Four types of QL block were described, differentiated by the exact location of the
anesthetic injection. Type 1/lateral QL block is performed at the lateral border of the QL
muscle, type 2/posterior QL block is performed at the medial edge of the QL muscle (at the
border or the spine erector muscles and the thoraco-lumbar fascia), type 3/anterior is
performed between the QL muscle and the psoas major and type 4 is intramuscular (see figure
1). In the majority of cases, these blocks are performed pre/post operatively under
ultrasound guidance. There are sporadic reports of QL block performed for lumbar spinal
surgery [3, 4].However, the plane for a type 2 QL block can be easily reached during open
midline spinal surgery.
The importance of pain control in the postoperative period for spinal surgery has been
discussed and proven extensively, with both immediate and delayed reduction in complications
and improved clinical results [5, 6].
The investigators hypothesize that the type 2 QL block is an effective analgesic tool for
lumbar laminectomy surgery, because in lumbar laminectomy the quadratus lumborum is already
exposed and is in direct visual contact. For that reason it is imperative, in our opinion, to
test its benefits of this procedure.
Study's objective:
To test the safety and efficacy of open quadratus lumborum block as an add-on postoperative
analgesic technique for lumbar spine decompression and fusion.
Study design:
This is a pilot comparative study, double blind and placebo controlled . Patients scheduled
for a lumbar spine decompression and fusion will be divided randomly into two groups of N=50
each. Subjects in both groups will receive an intra-operative exposure of the posterior QL
block plane, with injection of long acting local anesthetic for group A and Saline for group
B. Both groups will be monitored during their admission in the department for opioid dose
administered, reported pain levels (NRS), narcotics side effects (delirium, urinary
retention, falls) and general operative complications. Patient pain levels, satisfaction and
general complications will be gathered during clinic follow up.
Methods:
Patients arriving to undergo lumbar spine decompression and fusion will be offered to
participate in the study. They will receive a thorough explanation about the study and will
sign an informed consent form. The division into each group will be done randomly on a one by
one basis, by an operating room nurse. The scrubbed nurse will be exposed to the nature of
the substance injected for its sterile preparation, however the surgeons will be blinded to
it. Patients will be blinded to their study arm until the end of the study. The lumbar
laminectomy (open decompression) procedure will be performed as usual:
- First, the back is approached through a two-inch to five-inch long incision in the
midline of the back, and the left and right back muscles (erector spinae) are dissected
off the lamina on both sides and at multiple levels.
- After the spine is approached, the lamina is removed (laminectomy), allowing
visualization of the nerve roots.
- The facet joints, which are directly over the nerve roots, may then be undercut
(trimmed) to give the nerve roots more room.
- Fusion will be performed with pedicular screws and rods and when indicated an interbody
device.
Study group A will be given an analgesic injection into the quadratus lumborum, comprising of
Marcaine 0.25% with normal saline (for a total of 20 ml per side). Study group B will receive
an identical procedure, however with 20 ml normal saline alone per side. Time required to
perform the block for both sides will be measured.
The postoperative regime will include a standardized pain protocol as is used in routine
practice. all other operative or postoperative procedures are the same for both groups. Data
will be collected from nurses and physical therapy as well as discharge notes. A standardized
form for obtaining data will be used in clinic follow up at 2-3 weeks and 3-4 months.
Safety data collected:
A subjective report of each patient regarding any adverse events will be collected by the
study nurse during their recovery. The surgeon will report at the end of each operation if
there were any adverse events and level of difficulty administrating the injection on
designated forms.
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