Multicentre clinical simulation evaluation of the ISO 80369-6 neuraxial non-Luer connector.

To avoid potentially fatal wrong-route neuraxial drug errors, international standard ISO 80369-6 specifying a non-Luer neuraxial connector design was published in 2016. We describe usability studies used in development of the design. Thirty-eight doctors and 17 nurses performed simulated procedures on manikins, using devices fitted with Luer connectors or draft ISO 80369-6 'non-Luer' connectors. The procedures included spinal anaesthesia; intrathecal chemotherapy; lumbar puncture, cerebrospinal fluid collection and pressure measurement; epidural catheter placement with bolus injection and critical care use. Participants attempted cross connection between neuraxial connectors and a range of other medical device connectors, including those from the ISO 80369 small-bore connector series. Video recording analysis was used for all assessments. Participants subjectively assessed performance of the draft non-Luer connector, including suitability for routine clinical use. Participants performed 198 procedures. The connector achieved easy, leak-free connections. The willingness of participants to use the non-Luer connectors were: spinal anaesthesia 100%; intrathecal chemotherapy 88%; lumbar puncture, cerebrospinal fluid collection and pressure measurement 93%; epidural catheter placement with bolus injection 78%; critical care use 100%. Concerns raised were generally device related, rather than connector related. Most cross-connection attempts failed, even using above clinical forces and, when successful, were judged of low clinical risk potential; the exception was a malaligned connection between the non-Luer slip and female Luer connectors. This led to revision of the dimensional tolerances of the non-Luer connector to reduce this risk, before publication of the final specification in 2016. We conclude that the ISO 80369-6 neuraxial non-Luer connector is suitable for clinical use.

Continuous extrapleural intercostal nerve block after pleurectomy.

A randomised, double blind trial was carried out in 16 patients undergoing pleurectomy to assess the effect of continuous extrapleural intercostal block on postoperative pain and pulmonary function. Subjective pain relief was assessed on a linear visual analogue scale. Pulmonary function was measured on the day before operation and daily for five days after surgery. Eight patients received bupivacaine and eight placebo (saline). The mean pain scores at 4, 8, 16, and 24 hours were 13.3, 8.5, 6.1, and 10 mm respectively in the bupivacaine group compared with 56.3, 41, 46.7, and 35 in the control group; in addition, the bupivacaine group required less papaveretum. Twenty four hours after surgery mean values of peak expiratory flow, forced expiratory volume in one second, and forced vital capacity were reduced to 82%, 76%, and 76% of preoperative control values in the bupivacaine group, and to 39%, 32%, and 36% in the control group. The speed of recovery of pulmonary function was superior in the bupivacaine group. There were no complications related to the infusion. Continuous extrapleural intercostal nerve blockade with bupivacaine provides safe and effective postoperative analgesia and improves respiratory mechanics after pleurectomy.

Efficacy of continuous extrapleural intercostal nerve block on post-thoracotomy pain and pulmonary mechanics.

To assess the efficacy of continuous extrapleural intercostal nerve block on postoperative pain and pulmonary function, a prospective, randomized, double-blind, placebo-controlled trial was conducted on 56 patients undergoing elective thoracotomy. Infusion was started before closing the chest and was continued for 5 days. Subjective pain relief was assessed on a linear visual analogue scale. Pulmonary function was measured on the day before operation and daily for 5 days. There were 29 patients in a group which received bupivacaine and 27 in a control group which received saline. The bupivacaine group had lower pain scores (P less than 0.01) and required less papaveretum (P less than 0.01) than the control group. Forced vital capacity, forced expiratory volume in 1 s and peak expiratory flow rate were maximally reduced at 24 h to median values of 56, 60 and 57 per cent, respectively, of preoperative control values in the bupivacaine group, and to 25, 30 and 32 per cent in the control group. These differences are highly significant (P less than 0.01). Restoration of pulmonary function was superior in the bupivacaine group (P less than 0.01). There were no infusion-related complications. After thoracotomy, continuous intercostal blockade with bupivacaine is a safe and effective method of pain relief which reduces the early loss of postoperative pulmonary function significantly and more rapidly restores respiratory mechanics.

Pulmonary complications after lung resection: the effect of continuous extrapleural intercostal nerve block.

To assess the efficacy of continuous extrapleural intercostal nerve block (CEINB) with 0.5% bupivacaine on postoperative pain, pulmonary function and pulmonary complications, a prospective, randomised, double blind controlled trial was conducted on comparable patients undergoing lung resections; n = 21 (control), n = 25 (bupivacaine). The bupivacaine group required less papaveretum in the first 24 h (P less than 0.01) and had lower pain scores over 5 postoperative days (P less than 0.01). Pulmonary function recovered earlier in the bupivacaine group. Pulmonary complications occurred in 1 patient with normal lung function and 12 patients with obstructive airways disease (COAD): FEV1/FVC less than 70%. There were no infusion-related complications. CEINB has been shown to be safe and effective in reducing postoperative pain and pulmonary complications. CEINB minimises the loss of lung function after thoracotomy and restores impaired pulmonary mechanics more rapidly.