Effect of virtual reality hypnosis on intraoperative sedation needs and functional recovery in knee arthroplasty: a prospective randomized clinical trial.

BACKGROUND AND OBJECTIVES: Perioperative psychological stress and pharmacological anxiolysis can negatively affect the quality of recovery after total knee arthroplasty. We aimed to assess whether hypnosis combined with virtual reality could reduce intraoperative pharmacological sedation and improve quality of recovery after total knee arthroplasty surgery. METHODS: In this prospective randomized clinical trial, 60 patients scheduled for total knee arthroplasty with spinal anesthesia were randomly divided into 2 groups of 30 patients each. Intraoperatively, intermittent boluses of midazolam 1 mg were administered at 5 min intervals at the patient's request, with a maximum driven by the clinical assessment of sedation depth. During surgery, patients received standard care (group control) or virtual reality hypnosis (group VRH). An unblinded observer recorded the total dose of midazolam administered during surgery, and changes in the Quality-of-Recovery 15-item score, comfort, fatigue, pain and anxiety before and 1, 3 and 7 days after surgery. RESULTS: Patients in the VRH group required a lower dose of midazolam (mg; median (range)) intraoperatively (group VRH: 0 (0-4) and group control: 2 (0-9), p<0.001). Quality-of-Recovery 15-item, anxiety, and pain were similar between groups. CONCLUSIONS: In total knee arthroplasty with spinal anesthesia, VRH reduces the requirement for intraoperative pharmacological sedation, without a change in the quality of recovery. TRIAL REGISTRATION NUMBER: NCT05707234.

Oral as compared to intravenous tranexamic acid to limit peri-operative blood loss associated with primary total hip arthroplasty: A randomised noninferiority trial.

BACKGROUND: Oral as compared to intravenous tranexamic acid (TXA) is an attractive option, in terms of cost and safety, to reduce blood loss and transfusion in total hip arthroplasty. Exclusion criteria applied in the most recent randomised trials may have limited the generalisability of oral tranexamic acid in this indication. Larger and more inclusive studies are needed to definitively establish oral administration as a credible alternative to intravenous administration. OBJECTIVES: To assess the noninferiority of oral to intravenous TXA at reducing intra-operative and postoperative total blood loss (TBL) in primary posterolateral approached total hip arthroplasty (PLTHA). DESIGN: Noninferiority, single centre, randomised, double-blind controlled study. SETTING: Patients scheduled for primary PLTHA. Data acquisition occurred between May 2021 and November 2022 at the University Hospital of Liège, Belgium. PATIENTS: Two hundred and twenty-eight patients, randomised in a 1 : 1 ratio from a computer-generated list, completed the trial. INTERVENTIONS: Administration of 2 g of oral TXA 2 h before total hip arthroplasty and 4 h after incision (Group oral) was compared to the intravenous administration of 1 g of TXA 30 min before surgery and 4 h after incision (Group i.v.). MAIN OUTCOME MEASURES: TBL (measured intra-operative and drainage blood loss up to 48 h after surgery, primary outcome), decrease in haemoglobin concentration, D-Dimer at day 1 and day 3, transfusion rate (secondary outcomes). RESULTS: Analyses were performed on 108 out of 114 participants (Group i.v.) and 104 out of 114 participants (Group oral). Group oral was noninferior to Group i.v. with regard to TBL, with a difference between medians (95% CI) of 35 ml (-103.77 to 33.77) within the noninferiority margins. Median [IQR] of estimated TBL was 480 ml [350 to 565] and 445 ml [323 to 558], respectively. No significant interaction between group and time was observed regarding the evolution of TBL and haemoglobin over time. CONCLUSIONS: TXA as an oral premedication before PLTHA is noninferior to its intravenous administration regarding peri-operative TBL. TRIAL REGISTRATION: European Clinical Trial Register under EudraCT-number 2020-004167-29 ( https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-004167-29/BE ).

Effect of preoperative warming on intraoperative hypothermia and postoperative functional recovery in total hip arthroplasty: a randomized clinical trial.

BACKGROUND: Intraoperative hypothermia is associated with increased morbidity and impaired postoperative recovery. Direct anterior-approached total hip arthroplasty (ATHA) may lead to significant thermal loss. We aimed to assess whether preoperative warming had an impact on intraoperative hypothermia and postoperative functional recovery after ATHA. METHODS: In this prospective randomized controlled clinical trial 40 patients scheduled for ATHA were randomly divided into two groups of 20 patients each. Group W received, prior to the induction of general anesthesia, a 30 minutes 43 °C forced-air preoperative warming. Group C did not receive any preoperative warming. A blinded observer noted the core body temperature at the time of induction and at fixed time points, i.e. every five minutes during the first hour of surgery. The evolution of postoperative patient perceived thermal comfort (TC) and functional recovery (QoR-15) was assessed 24, 48 and 72 hours after surgery. Length of stay in the post-anesthesia care unit (PACU) was noted. RESULTS: The temperature drop was significantly faster and of higher amplitude in group C than in group W, during first hour of surgery (P<0.001). Evolution of QoR-15 and TC was significantly better in group W than in group C (P<0.001 for QoR-15 and P<0.001 for thermal comfort), with shorter length of stay (median [IQR]) in the PACU (minutes; 73 [61-79] for group C and 98 [83-129] for group W, P<0.001). CONCLUSIONS: In ATHA, pre-warming delays and reduces intraoperative heat loss, impacting patient comfort and postoperative functional recovery.

Comparison between supra-inguinal fascia iliaca and pericapsular nerve group blocks on postoperative pain and functional recovery after total hip arthroplasty: A noninferiority randomised clinical trial.

BACKGROUND: Pain after a posterolateral approach for total hip arthroplasty (THA) may affect early functional recovery. Supra-inguinal fascia iliaca (SFIB) and pericapsular nerve group (PENG) blocks have been proposed as promising analgesia techniques. OBJECTIVES: This trial was conducted to compare a PENG with a SFIB for controlling postoperative pain and for providing functional recovery. DESIGN: Noninferiority monocentric randomised controlled study. SETTING: One hundred and two patients scheduled for a total hip arthroplasty via the posterolateral approach under spinal anaesthesia were prospectively allocated to two groups. Data acquisition occurred between October 2021 and July 2022 at the University Hospital of Liege. PATIENTS: One hundred and two patients completed the trial. INTERVENTIONS: Group SFIB received supra-inguinal fascia iliaca block (SFIB) (40 ml ropivacaine 0.375%), whereas group PENG received a PENG block (20 ml ropivacaine 0.75%). MAIN OUTCOME MEASURES: Rest and mobilisation pain on a 0 to 10 numeric rating scale at fixed time points: 1 and 6 h after surgery, on day-1 and day-2 at 8 a.m.,1 p.m. and 6 p.m. On day-1 and day-2, evolution of quality-of-recovery-15 score was assessed, and timed-up-and-go, 2 and 6 min-walking tests. The noninferiority margin was set as 1 numeric rating scale point 6 h after surgery. RESULTS: Six hours after surgery, pain scores in group PENG were noninferior to those of group SFIB, with a difference between medians at 0 (95% CI -0.93 to 0.93). There were no significant differences between the groups regarding rest and dynamic pain trajectories during the first 48 postoperative hours, with no significant effects of group (rest P  = 0.800; dynamic P  = 0.708) or interaction between group and time (rest P  = 0.803; dynamic P  = 0.187). Similarly, no significant differences were observed regarding motor and functional recovery as assessed by timed-up-and-go ( P  = 0.197), 2 min ( P  = 0.364), and 6 min walking ( P  = 0.347) tests and quality-of-recovery-15 ( P  = 0.417) score. CONCLUSION: Following a total hip arthroplasty via the posterolateral approach, a PENG block is noninferior to SFIB regarding postoperative pain control 6 h after surgery, and functional recovery. TRIAL REGISTRATION: European Clinical Trial Register under EudraCT-number 2020-005126-28 ( https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-005126-28/BE ).

Effect of suprainguinal fascia iliaca compartment block on postoperative opioid consumption and functional recovery in posterolateral-approached total hip arthroplasty: a single-blind randomized controlled trial.

INTRODUCTION: Posterolateral-approached total hip arthroplasty (PLTHA) is followed by moderate to severe postoperative pain. Suprainguinal fascia iliaca compartment block (SFICB) has been proposed as a promising analgesia technique. METHODS: Data from 86 patients scheduled for PLTHA with spinal anesthesia were analyzed in this prospective randomized controlled trial. Patients were randomly divided into two groups of 43 patients each. As opposed to the control group (group C), ropivacaine group (group R) received additional SFICB using 40 mL of 0.375% ropivacaine. As primary endpoint, blind observers noted total morphine consumption at postoperative 48 hours. Secondary endpoints were pain at rest and mobilization on 0-10 Numeric Rating Scale (rest and dynamic NRS) at fixed time points (1 hour and 6 hours after surgery, and at day 1 and day 2 at 8:00, 13:00 and 18:00 hours), walking performance at day 1 and day 2; postoperative complications including morphine-related side effects or orthostatic intolerance symptoms such as dizziness, nausea, blurred vision or vasovagal syncope. RESULTS: A 48-hour morphine consumption (mg; median (IQR)) was significantly lower in group R than in group C (11 (8.5-15.5)) vs 26 (21-33.5), p<0001), as well as incidence of morphine-related side effects such as nausea at day 1 (p=0.04) and day 2 (p<0.01). Rest and dynamic NRS were globally significantly lower in group R than in group C (p<0.01). Group R showed less orthostatic intolerance at day 1 (p<0.001) and day 2 (p<0.01) and better functional walking performance at day 1 (<0.001) and day 2 (<0.001). DISCUSSION: In PLTHA, SFICB provides opioid sparing, improved postoperative pain control, and enhanced functional recovery. TRIAL REGISTRATION NUMBER: NCT04574479.

Influence of Levobupivacaine Regional Scalp Block on Hemodynamic Stability, Intra- and Postoperative Opioid Consumption in Supratentorial Craniotomies: A Randomized Controlled Trial.

BACKGROUND: The anesthetic management of supratentorial craniotomy (CR) necessitates tight intraoperative hemodynamic control. This type of surgery may also be associated with substantial postoperative pain. We aimed at evaluating the influence of regional scalp block (SB) on hemodynamic stability during the noxious events of supratentorial craniotomies and total intravenous anesthesia, its influence on intraoperative anesthetic agents' consumption, and its effect on postoperative pain control. METHODS: Sixty patients scheduled for elective CR were prospectively enrolled. Patient, anesthesiologist, and neurosurgeon were blind to the random performance of SB with either levobupivacaine 0.33% (intervention group [group SB], n = 30) or the same volume of saline (control group [group CO], placebo group, n = 30). General anesthesia was induced and maintained using target-controlled infusions of remifentanil and propofol that were adjusted according to hemodynamic parameters and state entropy of the electroencephalogram (SE), respectively. Mean arterial blood pressure (MAP), heart rate (HR), SE, and propofol and remifentanil effect-site concentrations (Ce) were recorded at the time of scalp block performance (Baseline), and 0, 1, 3, and 5 minutes after skull-pin fixation (SP), skin incision (SI), CR, and dura-mater incision (DM). Morphine consumption and postoperative pain intensity (0-10 visual analog scale [VAS]) were recorded 1, 3, 6, 24, and 48 hours after surgery. Propofol and remifentanil overall infusion rates were also recorded. Data were analyzed using 2-tailed Student unpaired t tests, 2-way mixed-design analysis of variance (ANOVA), and Tukey's honestly significant difference (HSD) tests for post hoc comparisons as appropriate. RESULTS: Demographics and length of anesthetic procedure of group CO and SB were comparable. SP, SI, and CR were associated with a significantly higher MAP in group CO than in group SB, at least at one of the time points of recording surrounding those noxious events. This was not the case at DM. Similarly, HR was significantly higher in group CO than in group SB during SP and SI, at least at 1 of the points of recording, but not during CR and DM. Propofol and remifentanil Ce and overall infusion rates were significantly higher in group CO than in group SB, except for propofol Ce during SP. Postoperative pain VAS and cumulative morphine consumption were significantly higher in group CO than in group SB. CONCLUSIONS: In supratentorial craniotomies, SB improves hemodynamic control during noxious events and provides adequate and prolonged postoperative pain control as compared to placebo.

Intravenous magnesium re-establishes neuromuscular block after spontaneous recovery from an intubating dose of rocuronium: a randomised controlled trial.

CONTEXT: Intravenous magnesium deepens non-depolarising neuromuscular block. OBJECTIVE: To assess whether intravenous magnesium has the potential to re-establish paralysis in patients who have just recovered from a non-depolarising neuromuscular block. DESIGN: Prospective randomised double-blind controlled study. PATIENTS: Twenty non-obese patients ranging in age from 18 to 80 years were enrolled. Exclusion criteria were a history of liver, kidney or neuromuscular disease and intake of medications interacting with neuromuscular blocking agents. INTERVENTION: After spontaneous recovery from an intubating dose of rocuronium had been achieved (train-of-four ratio ≥0.9), patients were given either a bolus dose of magnesium 50 mg kg(-1) intravenously or an equivalent volume of isotonic saline over 5 min. MAIN OUTCOME MEASURES: The train-of-four ratio was measured every minute until the end of surgery. The primary endpoint was the proportion of patients who experienced a decrease in train-of-four ratio following administration of magnesium or saline. RESULTS: Following infusion of the study solution, the train-of-four ratio decreased in all patients in the magnesium group in contrast to none in the saline group (P<0.001). On average, magnesium-induced train-of-four ratio depression reached a nadir of 0.49 after 10 min and lasted for 45 min. CONCLUSION: A bolus dose of intravenous magnesium 50 mg kg(-1) re-establishes a clinically relevant degree of muscle paralysis in patients who have just recovered from a non-depolarising neuromuscular block. TRIAL REGISTRATION: EudraCT.ema.europa.eu 2009-017372-24.