A Randomized Controlled Trial Using Epidural Analgesia for Pain Relief After Lumbar Interlaminar Decompressive Spine Surgery: The RAPID trial.

STUDY DESIGN: Prospective, double-blind randomized controlled trial. OBJECTIVE: If an intraoperative single bolus of epidural bupivacaine can result in less postoperative pain following lumbar spinal decompression surgery. SUMMARY OF BACKGROUND DATA: Adequate postoperative pain management following lumbar spinal decompression surgery is important, as it will lead to early mobilization, less complications, and a shorter hospital stay. Opioid consumption should be limited due to their frequently accompanied side effects and their addictive nature. During the final phase of lumbar decompression surgery, the epidural space becomes easily accessible. This might be an ideal moment for surgeons to administer an epidural bolus of analgesia as a safe and effective method for postoperative pain relief. MATERIALS AND METHODS: In this trial, we compared a single intraoperative bolus of epidural analgesia using bupivacaine 0.25% to placebo (NaCl 0.9%) and its effect on postoperative pain following lumbar spinal decompression surgery. The primary outcome was the difference in Numeric (Pain) Rating Scale between the intervention and placebo groups during the first 48 hours after surgery. RESULTS: Both the intervention group and the placebo group consisted of 20 randomized patients (N=40). Statistically significant lower mean Numeric (Pain) Rating Scale pain scores were observed in the intervention group in comparison with the control group (main effect group: -2.35±0.77, P =0.004). The average pain score was lower in the intervention group at all postoperative time points. No study-related complications occurred. CONCLUSION: This randomized controlled trial shows that administrating a bolus of intraoperative epidural bupivacaine is a safe and effective method for reducing early postoperative pain following lumbar decompression surgery.

Study protocol for a randomised controlled trial on the effect of local analgesia for pain relief after minimal invasive sacroiliac joint fusion: the ARTEMIS study.

INTRODUCTION: Chronic lower back pain is a common report in the general population. A dysfunctional sacroiliac joint (SIJ) is estimated to be responsible for one in five patients with lower back pain. Minimally invasive sacroiliac joint fusion (MISJF) is a surgical procedure to treat SIJ dysfunction. During the procedure, the SIJ is stabilised by implants inserted percutaneously under fluoroscopy guidance. Postoperatively, patients often report a lot of pain, which contributes to patients taking high doses of painkillers (opioids for example,) and preventing early mobilisation. In several orthopaedic procedures, intraoperative infiltration of the wound bed results in decreased consumption of analgesics, earlier mobilisation and shorter hospitalisation time. The aim of this study is to investigate the effectiveness of intraoperative SIJ infiltration with analgesia in reducing postoperative pain after MISJF. METHODS AND ANALYSIS: We will perform a two-centre, prospective, double-blind, randomised controlled trial to determine whether SIJ infiltration with 1.5-5 cc bupivacaine 0.50% is superior to 1.5-5 cc placebo (NaCl 0.9%) in reducing postoperative pain in patients after MISJF, and to determine whether bupivacaine significantly reduces opioid use in the direct postoperative period. Patients will be randomised with 1:1 allocation for either bupivacaine (intervention) or placebo SIJ infiltration. Postoperative pain will be measured by the Visual Analogue Scale pain score at entry and exit recovery, 2, 4, 6, 24 and 48 hours postoperatively. ETHICS AND DISSEMINATION: This is the first trial that investigates the effectiveness of intraoperative SIJ infiltration with bupivacaine 0.50% in reducing postoperative pain after MISJF. If intraoperative SIJ infiltration with bupivacaine 0.50% proves to be effective, this might have important clinical implications, such as postoperative analgesics (opioids for example,) consumption, earlier mobilisation and potentially shorter hospitalisation time. TRIAL REGISTRATION NUMBER: NL9151.

Intraoperative epidural analgesia for pain relief after lumbar decompressive spine surgery: A systematic review and meta-analysis.

Introduction: During lumbar decompressive spine surgery, the epidural space is easily accessible. This intraoperative situation allows surgeons to apply an epidural bolus of analgesia at the end of the surgical procedure. In literature, several papers about the methods and effectiveness of delivering local analgesia during lumbar decompressive spine surgery have been published. Research question: This systematic review and meta-analysis aims to summaries the current literature on the effectiveness and safety of intraoperative epidural analgesia in lumbar decompressive surgery, delivered as a bolus. Material and method: A systematic search was conducted according to the PRISMA guidelines. Inclusion criteria were randomized controlled trials or comparative cohort studies of patients aged 18 years or older who underwent decompressive lumbar spine surgery. Nonsteroidal epidural analgesia had to be administered as a bolus, intraoperatively, as an adjunct to standard analgesia therapy. Primary outcome measures were reduction in postoperative pain scores, analgesics consumption and length of hospital stay. Secondary outcomes were adverse events. Results: Eight studies evaluating the effectiveness of intraoperative epidural analgesia were included. Seven studies reported statistically significant reductions in postoperative VAS-pain scores. Six studies reported a statistically significant decrease in postoperative analgesics consumption. Four studies reported on the length of hospital stay, with no statistically significant difference between study groups. Discussion and conclusion: This systematic review and meta-analysis suggests that additional intraoperative epidural nonsteroidal analgesia, delivered as a bolus, can reduce postoperative pain and postoperative analgesics consumption in patients undergoing decompressive spinal surgery. Further well-powered research is needed to bolster the evidence.

Genetic polymorphisms and prediction of chronic post-surgical pain after hysterectomy-a subgroup analysis of a multicenter cohort study.

BACKGROUND: Chronic post-surgical pain (CPSP) is a serious problem. Clinical and psychological variables have not been able to explain all observed variance in prevalence and severity of CPSP. The first objective is to determine the association between genetic polymorphisms and the prevalence of CPSP after hysterectomy. The second objective is to analyze if the implementation of genetic polymorphisms into a previously performed clinical and psychological predictor analysis on the development of CPSP after hysterectomy will improve its discriminatory power. METHODS: A prospective multicenter cohort study was performed in patients undergoing hysterectomy for benign indication. Clinical and psychological variables were collected by questionnaires in the week before surgery, post-operatively up to day 4, 3 and 12 months after hysterectomy. Blood was collected and 16 polymorphisms previously suggested to be correlated to CPSP (COMT, GCH1, KCNS1, CACNG2, and OPRM1) were genotyped. Logistic regression analyses were performed. RESULTS: Three hundred and forty-five patients were available for the genetic analyses. The prevalence of CPSP 3 months post-operatively was 10.5% and after 12 months 7.9%. The polymorphism rs4818 within the COMT gene was associated with the prevalence of CPSP after 3 months. No polymorphisms were associated with CPSP after 12 months. The addition of rs4818 to the prediction model did not change its discriminatory power significantly. CONCLUSION: The rs4818 polymorphism within the COMT gene was associated with the prevalence of CPSP 3 months after hysterectomy, but the implementation of rs4818 into the prediction model did not significantly improve the chance of identifying hysterectomy patients at risk for CPSP.

[Kounis syndrome, the allergic acute coronary syndrome]. / Kounis-syndroom.

BACKGROUND: The occurrence of acute ischaemia or myocardial infarction in a patient experiencing an allergic reaction is known as allergic acute coronary syndrome or Kounis syndrome. CASE DESCRIPTION: A 63-year-old male had a postoperative anaphylactic reaction to an intravenous dose of diclofenac. Myocardial ischaemia occurred during treatment of the anaphylaxis, caused by spasm of the right coronary artery followed by occlusion of the left anterior descending artery (the ramus interventricularis anterior). Despite percutaneous coronary intervention, he suffered an infarct of the anterior myocardium, resulting in reduced left ventricular function. CONCLUSION: In patients with Kounis syndrome therapy should focus on both the allergy and the acute coronary syndrome. Early recognition and intervention have a great effect on prognosis.

Prevalence and Predictors of Patient Nonadherence to Pharmacological Acute Pain Therapy at Home After Day Surgery: A Prospective Cohort Study.

BACKGROUND: Good adherence to prescribed analgesics can be crucial to suppress or even prevent acute postoperative pain after day surgery. The aim of this study was to analyze prevalence and predictors of analgesic nonadherence after day surgery. METHODS: Elective patients scheduled for day surgery were prospectively enrolled from November 2008 to April 2010. Outcome parameters were measured by using questionnaire packages at 2 time points: 1 week preoperatively and 4 days postoperatively. The primary outcome parameter was analgesic nonadherence. Adherence was defined according to the patient's response to the questionnaire item "analgesia use as prescribed": full adherence, "yes"; partial adherence, "yes, sometimes"; nonadherence, "no." Bivariate and multivariate logistic regression analyses were performed to identify predictors of analgesic nonadherence. RESULTS: A total of 1,248 patients were included. The prevalence rates of analgesic nonadherence and partial adherence were 21.6% and 20.0%, respectively, in the total study population but dropped to 9.4% and 19.8%, respectively, in patients with moderate to severe pain. Low postoperative pain intensity and short duration of surgery were the most important predictors of analgesic nonadherence. The most important preoperative predictors for analgesic nonadherence were low preoperative pain intensity, low preoperative expectations of pain, and low fear of short-term effects of surgery. CONCLUSION: Analgesic nonadherence and partial adherence are common after day surgery but decrease as average pain intensity increases. Patients at risk for analgesic nonadherence can be identified during the preoperative period based on preoperative pain intensity, preoperative expectations of pain, and fear of surgery.

Procedure-Specific Pain Intensity Four Days After Day Surgery and the Relationship with Preoperative Pain: A Prospective Cohort Study.

BACKGROUND: Identification of painful procedures is essential for the development of procedure-specific pain-treatment schedules. The aim of this study was firstly, to analyze the prevalence of acute postsurgical pain (APSP) after various types of day surgery on the fourth postoperative day, and secondly, to assess the predictive value of preoperative pain for the development of APSP after different types of surgical procedures. METHODS: From November 2008 to April 2010, patients scheduled for elective day surgery were enrolled in this prospective cohort study. Data were collected one week preoperatively and four days postoperatively. The 11-point Numeric Rating Scale (NRS) was used for pain measurement. Moderate pain was defined as an NRS 4 to 5, and severe pain as an NRS > 5. The predictive value of preoperative pain for development of APSP was analyzed using a univariate logistic regression, stratified for the surgical procedure. RESULTS: From a total of 1123 included patients, 182 patients experienced moderate pain (16.3%) and 136 patients experienced severe pain (12.1%) on the fourth postoperative day. A large procedure-specific variability in APSP was observed, with shoulder, anal and dental surgery associated with the highest pain levels. Overall, preoperative pain significantly predicted postoperative pain on the fourth day (OR 4.45). This predictive value showed a procedure-specific variation and was not noted after various well-defined procedures. CONCLUSIONS: The prevalence of moderate to severe APSP was high four days after day surgery and showed a significant procedure-specific variation. Furthermore, there was a strong relationship between preoperative and postoperative pain, likewise characterized by a significant procedure-specific variation.

Metamizole versus ibuprofen at home after day surgery: study protocol for a randomised controlled trial.

BACKGROUND: Postoperative pain and, in a more extended perspective, quality of recovery (QOR) should be considered the principal endpoints after day surgery. Non-steroidal anti-inflammatory drugs (NSAIDs) and paracetamol are a cornerstone of pain treatment after painful day surgery. Nevertheless, NSAIDs are not always sufficiently effective, have numerous contraindications, and consequently are not suitable in up to 25 % of all patients. Metamizole is a non-opioid compound with a favourable gastrointestinal, cardiovascular and cerebrovascular profile compared to NSAIDs. The aim of this study is to assess if a combination of metamizole and paracetamol is non-inferior to a combination of ibuprofen and paracetamol in the treatment of acute postoperative pain at home after painful day case surgery. In addition, we aim to assess and compare quality of recovery (QOR) profiles of both groups. METHODS/DESIGN: This is an investigator-initiated, double-blind, randomised controlled, non-inferiority trial. A total of 200 patients undergoing elective haemorrhoid surgery, arthroscopic shoulder or knee surgery, or inguinal hernia repair in a day care setting will be randomised to receive either a combination of metamizole and paracetamol (MP) or a combination of ibuprofen and paracetamol (IP). Participants will take study medication orally for 4 days. Primary endpoints are average postoperative pain intensity measured by an 11-point Numeric Rating Scale at postoperative day 1 and QOR profile measured by the Functional Recovery Index (FRI), the 1-item Global Surgical Recovery (GSR) index and the EuroQol (EQ-5D) questionnaire at days 1, 2, 3, 4, 7, 14 and 28 postoperatively. Secondary outcomes include compliance with study medication, adverse effects of study medication, use of rescue medication and satisfaction with study medication, surgery and hospital care and telephone follow-up. DISCUSSION: This study will provide clinical evidence on the analgesic efficacy and safety of a combination of metamizole and paracetamol in treating postoperative pain at home after painful day surgery. This study may also provide an insight into QOR profile after four different types of surgery and into the interrelationship between three different instruments used to assess QOR. TRIAL STATUS: Recruitment is currently ongoing. TRIAL REGISTRATION: European Union Clinical Trials Register 2015-003987-35 . Registered 10 November 2015.

Prevalence and Predictive Factors of Chronic Postsurgical Pain and Global Surgical Recovery 1 Year After Outpatient Knee Arthroscopy: A Prospective Cohort Study.

Outpatient knee arthroscopy is one of the most commonly performed surgical procedures. Previous research has demonstrated that chronic postsurgical pain (CPSP) after outpatient surgery is prevalent. Our objective was to determine the prevalence and predictive factors of CPSP and Global Surgical Recovery (GSR) 1 year after knee arthroscopy.A prospective longitudinal cohort study was performed. Patients were included during an 18-month period. Data were collected by using 3 questionnaires: at 1 week preoperatively, 4 days postoperatively, and 1 year postoperatively. A value of >3 on an 11-point numeric rating scale (NRS) was defined as moderate to severe pain. A score of ≤80% on the Global Surgical Recovery Index was defined as poor GSR. Stepwise logistic regression analysis was performed to determine which variables were predictors for CPSP and poor GSR.The prevalence of moderate to severe preoperative pain in patients undergoing knee arthroscopy (n = 104) was 71.2%, of acute postsurgical pain 37.5%, and of CPSP 32.7%. Risk factors for CPSP were the presence of preoperative pain and preoperative analgesic use, with odds ratios of 6.31 (1.25-31.74) and 4.36 (1.58-12.07), respectively. The prevalence of poor GSR 1 year after outpatient knee arthrosocpy was 50.0%. Poor GSR 4 days after the surgery was a risk factor with an odds ratio of 8.38 (0.92-76.58) and quality of life 4 days after surgery was a protective factor with and odds ratio of 0.10 (0.02-0.64).Both CPSP and poor GSR are common 1 year after knee arthroscopy. Patients at risk for CPSP can be identified during the preoperative phase. Prediction of poor GSR 1 year after surgery is mainly related to early postoperative recovery.

Prevalence and Predictors of Quality of Recovery at Home After Day Surgery.

Traditionally, major complications and unanticipated admission/readmission rates were used to assess outcome after day surgery. However, in view of the relative absence of major complications the quality of recovery (QOR) should be considered one of the principal endpoints after day surgery. In our study, the level of QOR is defined by a combination of the Global Surgical Recovery (GSR) Index and the Quality of Life (QOL). The aim of this study was to analyze prevalence and predictors of QOR after day surgery on the fourth postoperative day. Elective patients scheduled for day surgery from November 2008 to April 2010 were enrolled in a prospective cohort study. Outcome parameters were measured by using questionnaire packages at 2 time points: 1 week preoperatively and 4 days postoperatively. Primary outcome parameter is the QOR and is defined as good if the GSR index >80% as well as the postoperative QOL is unchanged or improved as compared with baseline. QOR is defined as poor if both the GSR index ≤ 80% and if the postoperative QOL is decreased as compared with baseline. QOR is defined as intermediate in all other cases. Three logistic regression analyses were performed to determine predictors for poor QOR after day surgery. A total of 1118 patients were included. A good QOR was noted in 17.3% of patients, an intermediate QOR in 34.8%, and a poor QOR in 47.8% 4 days after day surgery. The best predictor for poor QOR after day surgery was type of surgery. Other predictors were younger age, work status, and longer duration of surgery. A history of previous surgery, expected pain (by the patient) and high long-term surgical fear were significant predictors of poor QOR in only 1 of 3 prediction models. The QOR at home 4 days after day surgery was poor in the majority of patients and showed a significant procedure-specific variation. Patients at risk for poor QOR can be identified during the preoperative period based on type of surgery, age, work status, and the duration of the surgery.

Prevalence and Predictive Factors of Chronic Postsurgical Pain and Poor Global Recovery 1 Year After Outpatient Surgery.

OBJECTIVES: To prospectively describe the prevalence and predictive factors of chronic postsurgical pain (CPSP) and poor global recovery in a large outpatient population at a university hospital, 1 year after outpatient surgery. MATERIALS AND METHODS: A prospective longitudinal cohort study was performed. During 18 months, patients presenting for preoperative assessment were invited to participate. Outcome parameters were measured by using questionnaires at 3 timepoints: 1 week preoperatively, 4 days postoperatively, and 1 year postoperatively. A value of >3 on an 11-point numeric rating scale was considered to indicate moderate to severe pain. A score of ≤80% on the Global Surgical Recovery Index was defined as poor global recovery. RESULTS: A total of 908 patients were included. The prevalence of moderate to severe preoperative pain was 37.7%, acute postsurgical pain 26.7%, and CPSP 15.3%. Risk factors for the development of CPSP were surgical specialty, preoperative pain, preoperative analgesic use, acute postoperative pain, surgical fear, lack of optimism, and poor preoperative quality of life. The prevalence of poor global recovery was 22.3%. Risk factors for poor global recovery were recurrent surgery because of the same pathology, preoperative pain, preoperative analgesic use, surgical fear, lack of optimism, poor preoperative and acute postoperative quality of life, and follow-up surgery during the first postoperative year. DISCUSSION: Moderate to severe CPSP after outpatient surgery is common, and should not be underestimated. Patients at risk for developing CPSP can be identified during the preoperative phase.