Unilateral cervical plexus block for prosthetic laryngoplasty in the standing horse.

BACKGROUND: Locoregional anaesthetic techniques can facilitate certain surgeries being performed under standing procedural sedation. The second and third spinal cervical nerves (C2, C3) are part of the cervical plexus and provide sensory innervation to the peri-laryngeal structures in people; block of these nerves might permit laryngeal lateralisation surgery in horses. OBJECTIVES: To describe the anatomical basis for an ultrasound-guided cervical plexus block in horses. To compare this block with conventional local anaesthetic tissue infiltration in horses undergoing standing prosthetic laryngoplasty. STUDY DESIGN: Cadaveric study followed by a double-blinded prospective clinical trial. METHODS: A fresh equine cadaver was dissected to characterise the distribution of C2 and C3 to the perilaryngeal structures on the left side. A second cadaver was utilised to correlate ultrasound images with the previously identified structures; a tissue marker was injected to confirm the feasibility of an ultrasound-guided approach to the cervical plexus. In the clinical study, horses were assigned to two groups, CP (n = 17; cervical plexus block) and INF (n = 17; conventional tissue infiltration). Data collection and analyses included time to completion of surgical procedure, sedation time, surgical field conditions and surgeon's perception of block quality. RESULTS: We confirmed that C2 and C3 provided innervation to the perilaryngeal structures. The nerve root of C2 was identified ultrasonographically located between the longus capitis and the cleidomastoideus muscles, caudal to the parotid gland. The CP group was deemed to provide better (P<0.0002) surgical conditions with no differences in the other variables measured. MAIN LIMITATIONS: Further studies with larger numbers of horses may be necessary to detect smaller differences in surgical procedure completion time based on the improved surgical filed conditions. CONCLUSIONS: For standing unilateral laryngeal surgery, a cervical plexus block is a viable alternative to tissue infiltration and it improves the surgical field conditions.

Indirect bioequivalence assessment using network meta-analyses.

AIMS: For market approval, new drug formulations (test) must demonstrate bioequivalence (BE) to at least one approved formulation (reference). If several formulations of a drug are already on the market, one might have to show BE to more than one reference formulation. Similarly, if several test formulations have shown BE to a reference formulation, it will be of interest whether the test formulations are bioequivalent to each other. METHODS: An enhanced statistical model to assess BE indirectly through a network meta-analysis is provided. Statistical properties of a parallel and a bridging approach are derived, in particular the relative statistical efficiency of the two approaches. The analysis is illustrated using individual subject data from two 3×3 crossover trials of metformin formulations, which have one of the formulations in common. RESULTS: The parallel estimate of relative bioavailability is confounded with between-trial differences, while the bridging estimate is not. The standard errors of the formulation differences using the bridging approach are smaller than the standard errors using the parallel approach if the within-subject correlation in each trial of the network is larger than 0.5. This is the condition for a crossover trial to be more efficient than a parallel trial, and thus is usually fulfilled in pharmacokinetic crossover trials. CONCLUSIONS: Indirect BE assessment offers the opportunity to efficiently determine the relative bioavailability of drug formulations that have not been studied in the same randomized BE trial. The methodology developed here allows estimating formulation differences across a larger network.