Abstract
BackgroundSpine surgery is associated with considerable postoperative pain and can be challenging to treat. A loco-regional technique suitable for spine surgery should cover the dorsal root of the spinal nerves at the levels where surgery is performed. The erector spinae block is a loco-regional technique with promising results and was recently described at the thoracic level. There are no randomized trials of this technique on a lumbar level. This study tests the hypothesis that the 24-h postoperative morphine consumption is significantly lower in patients undergoing posterior lumbar inter-body fusion surgery with a lumbar erector spinae (LUMBES) block when compared with a sham block.MethodsThis prospective randomized double-blind multicenter study will randomly allocate 80 adult patients undergoing elective posterior lumbar inter-body fusion surgery during general anesthesia to one of two groups as follows: (1) bilateral erector spinae block (20 mL 0.25% levobupivacaine) or (2) bilateral sham block (20 mL NaCl 0.9%). Our primary endpoint is 24-h postoperative morphine consumption. Secondary endpoints include 72-h morphine consumption, intraoperative sufentanil dosage, postoperative pain scores at regular time intervals both at rest and during movement, time to first postoperative mobilization, and the Quality of Recovery 40 survey score.DiscussionThe LUMBES trial is a pragmatic clinical study that will provide evidence of whether a bilateral lumbar erector spinae block is effective in reducing 24-h postoperative morphine consumption in patients undergoing lumbar inter-body fusion surgery. If this hypothesis is confirmed, this finding could contribute to more widespread implementation of this technique.Trial registrationLocal ethics committee B300201837508, ClinicalTrials.gov identifier: NCT03825198. Registered on 31 Jan 2019.
Highlights
Spine surgery is associated with considerable postoperative pain and can be challenging to treat
We performed a small feasibility trial in which we found that the erector spinae block (ESB) could be performed without major inconvenience for the patients (ClinicalTrials.gov identifier: NCT0321453)
We aim to determine the effect of a lumbar ESB on pain after back surgery, expressed as morphine consumption during the first 24 h postoperatively. In this prospective, randomized, double-blind placebocontrolled clinical trial, we will investigate the effect of bilateral ESB (20 mL of levobupivacaine 0.25%) on 24-h postoperative morphine consumption when compared with a sham block (20 mL of NaCl 0.9%) following posterior lumbar inter-body fusion surgery
Summary
Spine surgery is associated with considerable postoperative pain and can be challenging to treat. A loco-regional technique suitable for spine surgery should cover the dorsal root of the spinal nerves at the levels where surgery is performed. This study tests the hypothesis that the 24-h postoperative morphine consumption is significantly lower in patients undergoing posterior lumbar inter-body fusion surgery with a lumbar erector spinae (LUMBES) block when compared with a sham block. Background information Patients undergoing spine surgery often fear postoperative pain, which can be a source of considerable preoperative distress. In many of these patients, so-called chronic pain, requiring high doses of narcotics and other analgesics, has already been diagnosed. The introduction of ultrasound has allowed the performance of plane blocks and other techniques such as root blocks and facet infiltrations without the use of unreliable “pop-techniques” or x-ray
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