A prospective randomized double-blind trial of the efficacy of a bilateral lumbar erector spinae block on the 24h morphine consumption after posterior lumbar inter-body fusion surgery.

BACKGROUND: 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. 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. METHODS: This 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. DISCUSSION: The 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 REGISTRATION: Local ethics committee B300201837508, ClinicalTrials.gov identifier: NCT03825198 . Registered on 31 Jan 2019.

Cranial bone flap fixation using a new device (Cranial LoopTM).

BACKGROUND: Fixation of bone flaps after craniotomy is a routine part of every neurosurgical procedure and there are various options to fixate the bone flap. In this paper, we report on a new cranial bone flap fixation d(Cranial Loop) implanted in 35 consecutive patients. METHODS: The principle of cranial loop is the same as that of a tie rope. With a simple "pull and tighten" movement, the device is implanted without the need for additional instruments. The cranial loop is made of PEEK [poly(aryl)-ether-ether-ketone] material with the main advantage of being artifact free on postoperative imaging. In 35 consecutive patients operated by a single surgeon, the cranial loops were used for bone flap fixation. All patients had a postoperative CT scanning and a follow-up period of at least 9 months. RESULTS: In all patients, the bone flap could be easily fixed with 3 or more cranial loops without difficulties or material breakage, this within 3 min. The postoperative infection rate was 0%, postoperative hemorrhage (either epi/sub or intraparenchymatous) requiring reoperation was 0%. None of the patients experienced a bone flap dislocation, either clinically or on the postoperative CT-images. 3D CT-scanning revealed all of the flaps being in a good anatomic position. CONCLUSIONS: Although this is a preliminary report in a relatively small number of patients, we are of opinion that the cranial loop is a very fast, easy, and safe to use bone flap fixation device with the main advantage of the absence of artifacts on postoperative CT or MR imaging and lack of cosmetic disadvantage.