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

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

Transmuscular quadratus lumborum block versus thoracic paravertebral block for acute pain and quality of recovery after laparoscopic renal surgery: study protocol for a randomized controlled trial.

BACKGROUND: Quadratus lumborum block (QLB) is increasingly gaining popularity as a novel abdominal truncal block in abdominal surgery; however, the mechanism of QLB is not yet thoroughly illustrated. The focus of our study is transmuscular QLB (TMQLB), as the latest anatomical evidence shows that anesthetics spread into the thoracic paravertebral space to exert an analgesic effect. Therefore, we designed this study to compare TMQLB with thoracic paravertebral block (TPVB) in laparoscopic renal surgery in the hope of providing clinical evidence on the analgesic mechanism of TMQLB and its application in laparoscopic renal surgery. METHODS: This trial is a prospective, randomized, single-center, open-label, parallel, three-arm, non-inferiority trial. We intend to include 120 participants undergoing laparoscopic nephrectomy and before surgery they will be randomized into three groups for postoperative pain control: TMQLB experimental group 1 (0.4 ml/kg body weight 0.5% ropivacaine), TMQLB experimental group 2 (0.6 ml/kg body weight 0.5% ropivacaine) or TPVB control group (0.4 ml/kg body weight 0.5% ropivacaine at vertebra T10). Patients will be excluded if they have allergy to anesthetics, infection at the injection site, are on coagulopathy or anticoagulants, on analgesics for chronic illness, have history of substance abuse or have a barrier to communication. Morphine is given in boluses of 1.5~2 mg by intravenous patient-controlled analgesia (IPCA) in the first 48 h after surgery. The primary outcome is the difference between TMQLB group 1 and the TPVB group in the mean visual analogue scale (VAS) pain score in the first 24 h after surgery. Secondary outcomes are the difference between TMQLB group 2 and the TPVB group in the mean VAS score in the first 24 h after surgery, cumulative morphine consumption, long-term pain control, dermatomal distribution of sensory loss, nausea score, pruritus score, ambulation time, time till recovery of bowel movement, quality of recovery, postoperative length of hospital stay and patient satisfaction with anesthesia. Safety data on procedure-related complications will also be summarized. DISCUSSION: This will the first randomized controlled trial to compare TMQLB with TPVB for analgesia in laparoscopic surgery. This trial aims to provide important clinical evidence to elaborate on the analgesic mechanism of TMQLB. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03414281 . Registered on 9 January 2018.

Ultrasound-Assisted Thoracic Paravertebral Block Reduces Intraoperative Opioid Requirement and Improves Analgesia after Breast Cancer Surgery: A Randomized, Controlled, Single-Center Trial.

OBJECTIVES: The contribution of ultrasound-assisted thoracic paravertebral block to postoperative analgesia remains unclear. We compared the effect of a combination of ultrasound assisted-thoracic paravertebral block and propofol general anesthesia with opioid and sevoflurane general anesthesia on volatile anesthetic, propofol and opioid consumption, and postoperative pain in patients having breast cancer surgery. METHODS: Patients undergoing breast cancer surgery were randomly assigned to ultrasound-assisted paravertebral block with propofol general anesthesia (PPA group, n = 121) or fentanyl with sevoflurane general anesthesia (GA group, n = 126). Volatile anesthetic, propofol and opioid consumption, and postoperative pain intensity were compared between the groups using noninferiority and superiority tests. RESULTS: Patients in the PPA group required less sevoflurane than those in the GA group (median [interquartile range] of 0 [0, 0] vs. 0.4 [0.3, 0.6] minimum alveolar concentration [MAC]-hours), less intraoperative fentanyl requirements (100 [50, 100] vs. 250 [200, 300]µg,), less intense postoperative pain (median visual analog scale score 2 [1, 3.5] vs. 3 [2, 4.5]), but more propofol (median 529 [424, 672] vs. 100 [100, 130] mg). Noninferiority was detected for all four outcomes; one-tailed superiority tests for each outcome were highly significant at P<0.001 in the expected directions. CONCLUSIONS: The combination of propofol anesthesia with ultrasound-assisted paravertebral block reduces intraoperative volatile anesthetic and opioid requirements, and results in less post operative pain in patients undergoing breast cancer surgery. TRIAL REGISTRATION: ClinicalTrial.gov NCT00418457.

Comparison of combined general-epidural anesthesia with general anesthesia effects on survival and cancer recurrence: a meta-analysis of retrospective and prospective studies.

OBJECTIVE: Animals underwent combined general-epidural anesthesia (EGA) is reported to have better long-time outcome than general anesthesia (GA). This study aimed to make overall evaluation of the association between these two anesthetic techniques and prognosis of cancer patients undergoing surgery. METHODS: Related databases such as PubMed and EMbase were searched for eligible studies that evaluated the influence of EGA and GA on the prognosis of cancer patients undergoing surgery. Selected studies were evaluated according to the inclusion criteria by two reviewers respectively, followed by data extraction and quality assessment. The odds ratio (OR) with their 95% confidence intervals (CIs) were calculated to assess the influence strength of EGA and GA on prognosis of cancer patients. RESULTS: A total of ten studies involving 3254 patients were included. The overall results demonstrated that there was no significant difference between EGA and GA group (OR = 0.88, 95% CI 0.73 to 1.06, P = 0.187) concerning postoperative recurrence and metastasis rate. In regard to the following two factors: cancer category and time of follow-up, subgroup analysis identified significant differences between EGA and GA in the group of patients with prostate cancer and the group with follow-up less than or equal to two years (OR = 0.66, 95% CI 0.46 to 0.95, P = 0.027; OR = 0.70, 95% CI 0.51 to 0.98, P = 0.035; respectively) concerning postoperative recurrence and metastasis rate. However, no significant difference was found in the group of patients with colorectal cancer (OR = 1.06, 95% CI 0.84-1.33, P = 0.62). CONCLUSIONS: This meta-analysis showed that EGA might be associated with improvement in prognosis of patients with operable prostate cancer and the cancer patients with follow-up less than or equal to two years. However, no obvious relationship between the improvement in prognosis of colorectal cancer and EGA were detected, comparing to GA. Furthermore, all the results should be interpreted cautiously, as heterogeneous data were used for analyzing.

[Effect of ulinastatin on liver function of patients after bilateral total knee arthroplasty].

OBJECTIVE: To investigate the effect of ulinastatin, a urinary trypsin inhibitor, on the postoperative liver function in patients who have received bilateral total knee arthroplasty (TKA) under pneumatic tourniquet. METHODS: Totally 40 patients who were scheduled to receive bilateral TKA under thigh tourniquet were randomly assigned into trial group (U group, receiving intravenous ulinastatin) and control group (C group, receiving natural saline). All patients received the same general anesthesia and postoperative analgesia. The plasma concentrations of alanine transaminase (ALT), total bilirubin (TBil), and direct bilirubin (DBil) were recorded and compared preoperatively and 4, 24, 48, and 72 hours after the surgery. RESULTS: The demographic data were not significantly different between these two groups (P>0.05). The ALT was not significantly changed after the surgery in the C group (P>0.05) but was significantly decreased 48 hours (P=0.002) and 72 hours (P=0.001) after the surgery in the U group. TBil and DBil were significantly increased 48 hours (P=0.012, P=0.000) and 72 hours (P=0.000, P=0.000) after the surgery in C group, while only that at 48 hours (P=0.010, P=0.038) was significantly increased in the U group. ALT 4 hours (P=0.026), 48 hours (P=0.013), 72 hours (P=0.004) after the surgery were significantly lower in the U group than those in C group. TBil at the 72 hours postoperatively in U group was significantly lower than that in C group (P=0.036). DBil was not significantly different between C group and U group at all time points (all P>0.05). CONCLUSION: The application of ulinastatin in bilateral TKA can protect postoperative liver function.

[Application of lumber plexus blockade for hip fracture repair in elderly patients].

OBJECTIVE: To evaluate the lumber plexus blockade as anesthesia technique for hip fracture repair in elderly patients. METHODS: We retrospectively analyzed the peri-operative data of 87 hip fracture patients, aged 70 years or older, who underwent surgical repair at our hospital between 2003 and 2006. Patients were divided into three groups according the anesthesia techniques applied: general anesthesia (GA) group (n=21), epidural anesthesia (EA) group (n=37), and lumber plexus blockade (LPB) group (n=29). RESULTS: The peri-operative data were comparable among three groups, except that intra-operative the dosage of fentanyl was significantly lower in LPB group compared with in GA group(P0.05), and the blood urea nitrogen 1 day after surgery was significantly increased in GA group(P0.05). CONCLUSION: Lumber plexus blockade combined with small-dose intravenous anesthesia is an optional anesthetic technique for elderly patients undergoing hip fracture repair.

[Application of caffeine-halothane contracture test in the diagnosis of malignant hyperthermia].

OBJECTIVE: To explore the application of caffeine-halothane contracture test (CHCT) in the confirmation of malignant hyperthermia (MH). METHODS: One patient who underwent radical gastrectomy presented with clinical manifestations of MH during routine intravenous-inhalation anesthesia process. Isoflurane inhalation and the operation were ceased immediately and emergency management approaches such as physical cooling therapy were taken. Meanwhile, the levels of serum creatine kinase (CK), serum myoglobin, and urinary myoglobin were examined and rectus abdominis was taken and then CHCT was performed to confirm the clinical diagnosis. Total genome was extracted from the patient and then exons 2-18, 39-46, and 90-104 of ryanodine receptor 1 (RYR1) gene were screened to detect mutations using DNA sequencing technique. RESULTS: The patient was diagnosed as MH episode by clinical characteristics and postoperatively continuous elevation of the levels of CK, serum myoglobin, and urinary myoglobin (30 times higher than normal level). Despite halothane test was negative, the diagnosis of MH was verified by the positive result of caffeine test. DNA sequencing of RYR1 gene of the patient revealed c. 6724C > T (p. T 2 206M). CONCLUSION: CHCT can be used to confirm the diagnosis of MH.

Malignant hyperthermia in China.

Malignant hyperthermia has rarely been reported in China. We report the first case of malignant hyperthermia, verified by caffeine-halothane contracture test and genetic testing, in a Chinese patient.

Effect of volume replacement with hydroxyethyl starch solution on splanchnic oxygenation in patients undergoing cytoreductive surgery for ovarian cancer.

OBJECTIVE: To investigate the effectiveness of using a medium molecular weight hydroxyethyl starch solution (HES) administered as a replacement for estimated blood loss (EBL) during cytoreductive surgery for ovarian cancer on splanchnic oxygenation. METHODS: Forty-two patients undergoing cytoreductive surgery for ovarian cancer were enrolled in this prospective randomized study. As soon as the EBL exceeded 10% but was less than 20% of the estimated blood volume, the patients were randomly assigned to receive either a volume of lactated Ringer's solution (LRS) equal to three times the EBL (LRS group, n = 22) or a volume of 6% HES equal to the EBL (HES group, n = 20). Tissue oxygenation was assessed indirectly by measuring tonometric parameters, including the difference between gastric intramucosal PsCO(2) and arterial PaCO(2) (Ps-a CO(2) gap), gastric intramucosal pH (pHi) and arterial lactate acid concentration at 30 min after induction of anesthesia (baseline value), 1 hour and 2 hours after skin incision, and at the end of surgery. RESULTS: At the end of surgery,the Ps-a CO(2) gap in the HES group (8.7 +/- 1.6 mmHg) was significantly lower than that of the LRS group (18.74 +/- 4.4 mmHg, P < 0.01), while the pHi (7.30 +/- 0.05 mmHg) in the HES group was significantly higher than that of the LRS group (7.21 +/- 0.07 mmHg, P < 0.01). There was no significant difference between the two groups in terms of arterial lactate acid concentration. CONCLUSION: In patients undergoing major surgery with relatively large blood losses, volume resuscitation with medium molecular weight hydroxyethyl starch solution may improve splanchnic blood flow and tissue oxygenation.

[Effect of volume replacement with hydroxyethyl starch solution for blood loss on splanchnic oxygenation in patients undergoing cytoreductive surgery for ovarian carcinoma].

OBJECTIVE: To investigate the effect of medium molecular weight hydroxyethyl starch solution (HES) administered as replacement for estimated blood losses (EBL) during cytoreductive surgery for ovarian carcinoma on splanchnic oxygenation. METHODS: Cytoreductive surgery was operated upon forty-two patients with ovarian carcinoma. As soon as the EBL was higher than 10% but less than 20% of the estimated blood volume, the patients were randomly assigned to receive a volume of lactated Ringer's solution (LRS) equal to three times the EBL (LRS group, n = 22) or a volume of 6% HES equal to the EBL (HES group, n = 20). Tissue oxygenation was assessed indirectly by measuring the tonometric parameters of stomach, including difference between gastric intramucosal PsCO(2) and arterial PaCO(2) (Ps-aCO(2) gap), gastric intramucosal pH (pHi) and arterial lactate acid concentration 30 min after induction of anesthesia (baseline value), 1 h and 2 h after skin incision, and at the end of surgery. RESULTS: At the end of surgery, the Ps-aCO(2) gap was 8.7 mm Hg +/- 1.6 mm Hg in the HES group, significantly lower than that in the LRS group (18.74 mm Hg +/- 4.4 mm Hg, P < 0.01), while the pHi in the HES group was 7.30 +/- 0.05, significantly higher than that in the LRS group (7.21 +/- 0.07, P < 0.01). There was no significant difference in arterial lactate acid concentration between the two groups. CONCLUSION: In patients undergoing major surgery, volume resuscitation with medium molecular weight HES improves the splanchnic blood flow and tissue oxygenation.