Perioperative patient-controlled regional analgesia versus patient-controlled intravenous analgesia for patients with critical limb ischaemia: a study protocol for a randomised controlled trial

摘要: Introduction Both regional analgesia and intravenous are frequently used perioperatively for patients with critical limb ischaemia (CLI). Nevertheless, the comparison of perioperative effect has not yet been thoroughly illustrated. This study will comprehensively compare patient-controlled (PCRA) (PCIA) as two different approaches CLI. It investigates their effects on analgesia, reperfusion quality recovery perioperatively, also aims to provide clinical evidence those non-surgical non-reconstructable arteries. Methods analysis trial is a randomised, single-centre, open-label, parallel target sample size 52 in total. Eligible participants be randomly allocated PCRA group (group R) or PCIA I) after admission. Participants R receive ultrasound-guided subgluteal sciatic catheterisation, followed by continuous infusion (0.2% ropivacaine 15 mL loading dose, 8 mL/hour background bolus 6 mL). I (morphine given boluses 1 mg needed, at 1 mg/hour). Data collected baseline (T0), 2 hours before revascularisation treatment (T1) discharge (T2). The primary outcomes include Numerical Rating Scale pain score T1 T2. secondary transcutaneous oxygen pressure, Tissue Haemoglobin Index, Hospital Anxiety Depression T2; Patient Global Impression Change patient satisfaction cumulative morphine consumption, length postoperative hospital stay adverse events. Ethics dissemination received authorisation from Institutional Review Board Peking Union Medical College 21 March 2017 (approval no. ZS-1289X). Study findings disseminated through presentations scientific conferences publications peer-reviewed journals. Trial registration number Chinese Clinical Registry (ChiCTR2000029298). Protocol version V.4CP.B2 (15 June 2020).