The effectiveness of ambulatory continuous popliteal sciatic nerve blockade on patient-reported overall benefit of analgesia in patients undergoing foot or ankle surgery (CAREFREE trial); a randomized, open label, non-inferiority trial.

STUDY OBJECTIVE: Management of pain after foot and ankle surgery remains a concern for patients and healthcare professionals. This study determined the effectiveness of ambulatory continuous popliteal sciatic nerve blockade, compared to standard of care, on overall benefit of analgesia score (OBAS) in patients undergoing foot or ankle surgery. We hypothesized that usage of ambulatory continuous popliteal sciatic nerve blockade is non-inferior to standard of care. DESIGN: Single center, randomized, non-inferiority trial. SETTING: Tertiary hospital in the Netherlands. PATIENTS: Patients were enrolled if ≥18 years and scheduled for elective inpatient foot or ankle surgery. INTERVENTION: Patients were randomized to ambulatory continuous popliteal sciatic nerve blockade or standard of care. MEASUREMENTS: The primary outcome was the difference in OBAS, which includes pain, side effects of analgesics, and patient satisfaction, measured daily from the first to the third day after surgery. A non-inferiority margin of 2 was set as the upper limit for the 90% confidence interval of the difference in OBAS score. Mixed-effects modeling was employed to analyze differences in OBAS scores over time. Secondary outcome was the difference in opioid consumption. MAIN RESULTS: Patients were randomized to standard of care (n = 22), or ambulatory continuous popliteal sciatic nerve blockade (n = 22). Analyzing the first three postoperative days, the OBAS was significantly lower over time in the ambulatory continuous popliteal sciatic nerve blockade group compared to standard of care, demonstrating non-inferiority (-1.9 points, 90% CI -3.1 to -0.7). During the first five postoperative days, patients with ambulatory continuous popliteal sciatic nerve blockade consumed significantly fewer opioids over time compared to standard of care (-8.7 oral morphine milligram equivalents; 95% CI -16.1 to -1.4). CONCLUSIONS: Ambulatory continuous popliteal sciatic nerve blockade is non-inferior to standard of care with single shot popliteal sciatic nerve blockade on patient-reported overall benefit of analgesia.

The effectiveness of a transitional pain service in patients undergoing surgery with an increased risk of developing chronic postsurgical pain (TRUSt study). A randomized clinical trial.

STUDY OBJECTIVE: Poorly controlled acute postsurgical pain is associated with delayed recovery, chronic postsurgical pain (CPSP), chronic opioid use and impaired functioning in daily activities. The aim was to determine the effectiveness of a transitional pain service (TPS) to improve quality of recovery for patients at risk of CPSP. We hypothesized that a TPS improves the quality of recovery in patients at risk of CPSP. DESIGN: Single-center, pragmatic, randomized, superiority trial. SETTING: Tertiary hospital in the Netherlands. PATIENTS: Assessed for eligibility if ≥18 years of age, undergoing elective surgery, and had an increased risk of developing CPSP. After being stratified for sex, 176 patients were included. INTERVENTION: Patients were randomized to receive TPS or standard of care (SOC). TPS was a multidisciplinary intervention providing a patient-tailored perioperative pain management plan, throughout all phases of surgery. MEASUREMENTS: The primary outcome was the difference in quality of recovery on the third postoperative day, measured by the Quality of Recovery (QoR)-15 questionnaire. Secondary outcomes include the between group differences in opioid consumption. MAIN RESULTS: The primary outcome was available in 169 (96.0%) patients. No difference between groups was found in QoR-15 on the third postoperative day (mean difference 2.0, 95% CI -5.5 to 9.4, p = 0.607). A decrease in opioid usage (compared to baseline) was observed in chronic opioid users, the median [IQR] reduction in total daily oral morphine milligram equivalents (MME) for TPS was -30 [-60, 0] at three and - 29.3 [-65.6, 0] at six months, whereas SOC had a median reduction of 0 [-56, 0] at three, and 0 [-60, 7.5] at six months. CONCLUSIONS: TPS did not significantly affect short-term quality of recovery but might improve long-term outcomes, such as the incidence of chronic pain, opioid consumption, and functioning in daily life. However, sample size in the present study was too small to provide solid evidence for this positive signal.

Comparison of Two Versus Three Bilateral Botulinum Toxin Injections Prior to Abdominal Wall Reconstruction.

Background: Intramuscular injection of botulinum toxin A (BTA) induces a temporary muscle paralysis. In patients with a ventral hernia, preoperative injection of BTA in the muscles of the lateral abdominal wall (LAW) leads to thinning and lengthening of these muscles, making fascial closure more likely. In many hernia centres, treatment with BTA prior to abdominal wall reconstruction has therefore become standard care. However, evidence on the optimal BTA strategy is lacking. Methods: In this single-centre retrospective study, we analysed a consecutive cohort of ventral hernia patients that underwent bilateral BTA injections prior to abdominal wall reconstruction with available CT before and after BTA. We only included patients that were treated with exactly 600 units of Dysport®, diluted into 120 mL of saline, via either two- or three injections on each side into all three LAW muscle layers. The primary outcome was the change in LAW muscle length and thickness, comparing CT measures from before BTA and 4-6 weeks after the injections. Results: We analysed 67 patients; 30 had received two injections bilaterally and 37 had received three injections bilaterally. Baseline data showed no significant differences in LAW muscle thickness or length between groups. In both groups, the median LAW muscle thickness decreased with 0.5 cm (p < 0.001). The LAW muscle length increased with 0.9 cm (p = 0.001) and 1.2 cm (p < 0.001) in the two- and three bilateral injection group, respectively. The BTA-induced changes in LAW thickness and length were not significantly different between both groups (p = 0.809 and p = 0.654, respectively). Discussion: When using the exact same dosage and distribution volume of BTA in patients with a complex abdominal wall defect, two injections bilaterally in the lateral abdominal wall muscles are as effective as three injections bilaterally.

[Botox preceding ventral hernia repair: it's not about esthetics]. / Botox voorafgaand aan littekenbreukcorrecties.

Ventral hernia is a common complication after laparotomy. The aim during ventral hernia repair is to close the abdomen through medialization of the rectus muscles. Particularly in patients with large ventral hernia, chronically retracted lateral muscles may preclude muscle medialization and therewith closure of the abdomen. A recent development in abdominal wall surgery is the injection of botulinum toxin (botox) in the lateral abdominal wall muscles a few weeks prior to surgery. These intramuscular injections cause a temporary partial paralysis resulting in elongation of the lateral muscles, compared to pre-botox contracted and retracted lateral muscles, and therewith facilitate closure of the abdomen. Despite positive first results only little is known about this new application of botox. In this article we discuss both the technical aspects as well as the current state of this new technique.

Study protocol for the TRUSt trial: a pragmatic randomised controlled trial comparing the standard of care with a transitional pain service for patients at risk of chronic postsurgical pain undergoing surgery.

INTRODUCTION: Patients with either surgery-related or patient-related risk factors are at an increased risk of acute and chronic postsurgical pain (CPSP) and long-term opioid use. To improve recovery, prevent CPSP and decrease opioid use, we need to identify these patients before surgery and provide a multidisciplinary pain management strategy throughout hospital admission and follow-up in the postdischarge period. We hypothesise that a multidisciplinary transitional pain service (TPS) improves quality of recovery and reduce the incidence of CPSP and opioid consumption. METHODS AND ANALYSIS: We aim to investigate the effectiveness of implementation of a TPS for patients at risk of developing CPSP. The trial design is a pragmatic, open-label, randomised controlled trial (RCT). After stratification for sex, patients are randomly assigned to the TPS or standard of care (SOC) group. Our primary outcome is the quality of recovery, measured at the morning of the third postoperative day, employing the quality of recovery (QoR)-15 questionnaire. Secondary outcomes are the incidence of CPSP, opioid consumption and patient-reported outcome measures at 3 and 6 months postoperatively. We need to enrol 176 patients to detect a minimal clinical important difference of 8 points on the QoR-15 score. ETHICS AND DISSEMINATION: Ethics approval was obtained by the accredited medical research ethics committee of the Academic Medical Center in Amsterdam (2020_211) on 15 October 2020. Protocol version 3.2 was approved on 25 January 2020. The trial is registered with the Netherlands Trial Register, NL9115. The results will be disseminated by open access publication in a peer-reviewed journal.Trial registration number NL9115.

Goal-directed fluid therapy vs. low central venous pressure during major open liver resections (GALILEO): a surgeon- and patient-blinded randomized controlled trial.

BACKGROUND: Low central venous pressure (low-CVP) is the clinical standard for fluid therapy during major liver surgery. Although goal-directed fluid therapy (GDFT) has been associated with reduced morbidity and mortality in major abdominal surgery, concerns remain on blood loss when applying GDFT in liver surgery. This randomized trial compared outcomes of low-CVP and GDFT during major liver resections. METHODS: In this surgeon- and patient-blinded RCT, patients undergoing major open liver resections (≥3 segments) were randomized between low-CVP (n = 20) or GDFT (n = 20). Primary outcome was intraoperative blood loss. Secondary outcomes included the quality of the surgical field (VAS scale 0 (worst)-100 (best)) and major morbidity (≥grade 3 Clavien-Dindo). RESULTS: During surgery, CVP was 3 ± 2 mmHg in the low-CVP group vs. 7 ± 3 mmHg in the GDFT group (P < 0.001). Blood loss (1425 vs. 1275 mL; P = 0.640) and the rate of major morbidity (40% vs. 50%, P = 0.751), did not differ between low-CVP and GDFT, respectively. The quality of the surgical field was comparable between groups (low-CVP 83% vs. GDFT 80%, P = 0.955). CONCLUSION: In major open liver resections, GDFT was not associated with differences in intraoperative blood loss, major morbidity or quality of the surgical field, compared to low-CVP. Larger RCTs are needed to confirm this finding. Registration number: NTR5821 (www.trialregister.nl).