<span class="paragraphSection"><div class="boxTitle">Abstract</div><strong>Background.</strong> The incidence of hemidiaphragmatic paresis with continuous interscalene brachial plexus block (CISB) can approach 100%. We tested the hypothesis that extrafascial placement of the catheter tip reduces the rate of hemidiaphragmatic paresis compared with intrafascial tip placement for CISB while providing effective analgesia.<strong>Methods.</strong> Seventy patients undergoing elective major shoulder surgery under general anaesthesia were randomized to receive an ultrasound-guided CISB plexus block for analgesia with the catheter tip placed either within (intrafascial group) or immediately outside (extrafascial group) the brachial plexus sheath midway between the levels of C5 and C6. Catheters were bolus dosed with ropivacaine 0.5% 20 ml before surgery, followed by an infusion of ropivacaine 0.2% at 4 ml h<sup>−1</sup> for the first 2 days after surgery. The primary outcome was hemidiaphragmatic paresis measured by M-mode ultrasonography on postoperative day (POD) 1. Secondary outcomes included forced vital capacity, forced expiratory volume in 1 s, and rest pain scores.<strong>Results.</strong> The incidence of hemidiaphragmatic paresis on POD 1 was significantly reduced in the extrafascial group {intrafascial, 41% [95% confidence interval (CI) 25–59%]; extrafascial, 15% (95% CI 5–32%); <span style="font-style:italic;">P</span>=0.01}. We were unable to detect a difference between groups in any of the functional respiratory outcomes or in rest pain scores [numerical rating scale (1–10): intrafascial, 3 (95% CI 2–3); extrafascial, 3 (95% CI: 2–4); <span style="font-style:italic;">P</span>=0.93] on POD 1.<strong>Conclusions.</strong> Placement of the catheter tip immediately outside of the brachial plexus sheath reduced the incidence of hemidiaphragmatic paresis on POD 1 associated with ultrasound-guided CISB while providing effective analgesia after major shoulder surgery. Our results do not support the routine placement of the catheter tip within the brachial plexus sheath for CISB.<strong>Clinical trial registration.</strong> NCT02433561.</span>
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