Dataset Information

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.

ABSTRACT:

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.

SUBMITTER: Admiraal M

PROVIDER: S-EPMC8365802 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundTonsillectomy is a frequently performed surgical procedure in children; however, few multimodal analgesic strategies have been shown to improve postsurgical pain in this patient population. Systemic magnesium infusions have been shown to reliably improve postoperative pain in adults, but their effects in pediatric surgical patients remain to be determined. In the current investigation, our main objective was to evaluate the use of systemic magnesium to improve postoperative pain in pediatric patients undergoing tonsillectomy. We hypothesized that children who received systemic magnesium infusions would have less post-tonsillectomy pain than the children who received saline infusions.MethodsThe study was a prospective, randomized, double-blinded, clinical trial. Subjects were randomly assigned using a computer-generated table of random numbers to 1 of the 2 intervention groups: systemic magnesium infusion (initial loading dose 30 mg/kg given over 15 minutes followed by a continuous magnesium infusion 10 mg/kg/h) and the same volume of saline. The primary outcome was pain scores in the postanesthesia care unit (PACU) measured by FLACC (Face, Legs, Activity, Cry, Consolability) pain scores. Pain reduction was measured by the decrement in the area under the pain scale versus 90-minute postoperative time curve using the trapezoidal method. Secondary outcomes included opioid consumption in the PACU, emergence delirium scores (measured by the pediatric anesthesia emergence delirium scale), and parent satisfaction.ResultsSixty subjects were randomly assigned and 60 completed the study. The area under pain scores (up to 90 minutes) was not different between the study groups, median (interquartile range [IQR]) of 30 (0-120) score × min and 45 (0-135) score × min for the magnesium and control groups, respectively (P = 0.74). Similarly, there was no clinically significant difference in the morphine consumption in the PACU between the magnesium group, median (IQR) of 2.0 (0-4.44) mg IV morphine, compared with the control, median (IQR) of 2.5 (0-4.99) mg IV morphine (P = 0.25). The serum level of magnesium was significantly lower in the control group than in the treatment group at the end of the surgery (P < 0.001).ConclusionsDespite a large number of studies demonstrating the efficacy of systemic magnesium for preventing postsurgical pain in adults, we could not find evidence for a significant clinical benefit of systemic magnesium infusion in children undergoing tonsillectomies. Our findings reiterate the importance of validating multimodal analgesic strategies in children that have been demonstrated to be effective in the adult population.

Project description:Importance:Effective postoperative pain management increases patient satisfaction, reduces cost, reduces morbidity, and shortens hospitalizations. Previous studies investigating multimodal pain therapy in otolaryngology patients focused on homogenous patient groups with short postoperative follow-up times. Objective:To investigate the effect of perioperative gabapentin treatment on postsurgical pain in patients undergoing head and neck mucosal surgery. Design, Setting, and Participants:Adults undergoing head and neck mucosal surgery from July 25, 2016, through June 19, 2017, were included in this double-blinded, placebo-controlled randomized clinical trial and randomized to receive gabapentin, 300 mg twice daily, or placebo before surgery and up to 72 hours after surgery. Main Outcomes and Measures:Primary outcome was hourly narcotic use calculated in morphine equivalents. Secondary outcomes included subjective visual analog scale pain scores captured for resting, coughing, and swallowing using a 0- to 100-mm scale (a 100-mm line anchored with no pain on the left end and worst possible pain on the right end). A change of 10 mm or more was deemed to be clinically meaningful. Additional secondary outcome measures included degree of pain control, patient satisfaction, and adverse effects. Results:Of the 110 patients randomized to receive gabapentin or placebo, 11 and 10 withdrew from each group, respectively. Ninety patients were then analyzed: 44 in the gabapentin group (mean [SD] age, 61.1 [10.0] years; 33 [75%] male; 40 [91%] white) and 46 in the placebo group (mean [SD] age, 60.9 [11.3] years; 35 [78%] male; 43 [94%] white). Both groups had similar self-reported levels of preoperative pain and narcotic effectiveness. A median difference of 0.26 mg/h of morphine (95% CI, -0.27 to 0.94 mg/h) was found between groups. After controlling for comorbidity and self-reported baseline pain levels, mixed model analysis found the difference in marginal means of visual analog scale scores between groups to be lower in the gabapentin group compared with the placebo group for all categories (rest difference, 7.9 mm; 95% CI, -0.4 to 16.2 mm; cough difference, 8.9 mm; 95% CI, -0.5 to 18.3 mm; swallow difference, 9.4 mm; 95% CI, -1.2 to 20.0 mm). More patients in the gabapentin group reported that pain was always well controlled than in the placebo group (difference, 9.2%; 95% CI, -21% to 3%). Gabapentin and placebo groups reported similar levels of satisfaction with pain control (difference, 2%; 95% CI, -11% to 15%). There was no clinically meaningful difference in reported nausea between the 2 groups (difference, 6%; 95% CI, -14% to 26%). Conclusion and Relevance:Perioperative gabapentin given 300 mg twice daily did not result in reduced narcotic use, but results were compatible with clinically meaningful reductions in pain scores. Satisfaction with pain control and adverse effects were similar between groups. Trial Registration:ClinicalTrials.gov Identifier: NCT02926573.

Project description:BackgroundChronic postsurgical pain (CPSP) is a clinical problem, and large prospective studies are needed to determine its incidence, characteristics, and risk factors.ObjectiveTo find predictive factors for CPSP in an international survey.DesignObservational study.SettingMulticentre European prospective observational trial.PatientsPatients undergoing breast cancer surgery, sternotomy, endometriosis surgery, or total knee arthroplasty (TKA).MethodStandardised questionnaires were completed by the patients at 1, 3, and 7 days, and at 1, 3, and 6 months after surgery, with follow-up via E-mail, telephone, or interview.Main outcome measureThe primary goal of NIT-1 was to propose a scoring system to predict those patient likely to have CPSP at 6 months after surgery.ResultsA total of 3297 patients were included from 18 hospitals across Europe and 2494 patients were followed-up for 6 months. The mean incidence of CPSP at 6 months was 10.5%, with variations depending on the type of surgery: sternotomy 6.9%, breast surgery 7.4%, TKA 12.9%, endometriosis 16.2%. At 6 months, neuropathic characteristics were frequent for all types of surgery: sternotomy 33.3%, breast surgery 67.6%, TKA 42.4%, endometriosis 41.4%. One-third of patients experienced CPSP at both 3 and 6 months. Pre-operative pain was frequent for TKA (leg pain) and endometriosis (abdomen) and its frequency and intensity were reduced after surgery. Severe CPSP and a neuropathic pain component decreased psychological and functional wellbeing as well as quality of life. No overarching CPSP risk factors were identified.ConclusionUnfortunately, our findings do not offer a new CPSP predictive score. However, we present reliable new data on the incidence, characteristics, and consequences of CPSP from a large European survey. Interesting new data on the time course of CPSP, its neuropathic pain component, and CPSP after endometriosis surgery generate new hypotheses but need to be confirmed by further research.Trial registrationclinicaltrials.gov ID: NCT03834922.

Project description:BACKGROUND:There is limited experimental evidence on transitional care interventions beyond 30 days post-discharge and in vulnerable populations. OBJECTIVE:Evaluate effects of a transitional care practice (TC) that comprehensively addresses patients' medical and psychosocial needs following hospital discharge. DESIGN:Pragmatic, randomized comparative effectiveness trial. PATIENTS:Adults discharged from an initial emergency, observation, or inpatient hospital encounter with no trusted usual source of care. INTERVENTIONS:TC intervention included a scheduled post-discharge appointment at the TC practice, where a multidisciplinary team comprehensively assessed patients' medical and psychosocial needs, addressed modifiable barriers, and subsequent linkage to a new primary care source. Routine Care involved assistance scheduling a post-discharge appointment with a primary care provider that often partnered with the hospital where the initial encounter occurred. MAIN MEASURES:The primary outcome was a binary indicator of death or additional hospital encounters within 90 days of initial discharge. Secondary outcomes included any additional hospital encounters, and counts of hospital encounters, over 180 days. KEY RESULTS:Four hundred ninety patients were randomized to TC intervention and 164 to Routine Care; 34.6% were uninsured, 49.7% had Medicaid, and 57.4% were homeless or lived in a high-poverty area. There was no significant difference between arms in the 90-day probability of death or additional hospital encounters (relative risk [RR] 0.89; 0.91; 95% confidence interval [CI] 0.74-1.13). However, TC patients had 37% and 35% lower probability of any inpatient admission over 90 days (RR 0.63; 95% CI 0.43-0.91) and 180 days (RR 0.65; 95% CI 0.47-0.89), respectively. Over 180 days, TC patients had 42% fewer inpatient admissions (incidence rate ratio 0.58; 95% CI 0.37-0.90). CONCLUSIONS:Among patients randomized to a patient-centered transitional care intervention, there was no significant reduction in 90-day probability of death or additional hospital encounters. However, there were significant decreases in measures of inpatient admissions over 180 days. TRIAL REGISTRATION:clinicaltrials.gov identifier NCT03066492.

Project description:In response to the opioid crisis, the 2016 Vermont legislature commissioned a study to assess acupuncture for patients with chronic pain in the Vermont Medicaid population.To assess the feasibility, acceptability, and effectiveness of acupuncture provided by licensed acupuncturists for Vermont Medicaid patients with chronic pain.A total of 156 Medicaid patients with chronic pain were offered up to 12 acupuncture treatments within a 60-day period at the offices of 28 Vermont licensed acupuncturists. PROMIS® questionnaires were administered prior to and at the end of the treatment period to assess changes in pain intensity, pain interference, physical function, fatigue, anxiety, depression, sleep disturbance, and social isolation. Questionnaires also captured patients' overall impressions of treatments as well as self-reported changes in medication use and work function.One hundred eleven women (71%) and 45 men (29%) with a wide range of pain complaints received a mean of 8.2 treatments during the intervention period. Measurements captured prior to and at the end of the treatment period showed significant improvements in group mean pain intensity, pain interference, physical function, fatigue, anxiety, depression, sleep disturbance, and social isolation as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) measures (paired t tests, P < .01). Fifty-seven percent of patients using analgesic (nonopioid) medication reported reductions in use. Thirty-two percent of patients using opioid medication reported reductions in use of opioid medication following the intervention. Seventy-four percent of employed patients reported improved capacity to work. Ninety-six percent of patients said that they would recommend acupuncture to others with chronic pain, and 91% reported qualitative improvements, including physical (31%), functional/behavioral (29%), and psycho-emotional (24%) improvements.Our findings demonstrate that acupuncture treatment for chronic pain is feasible and well received by patients in the Vermont Medicaid population. Receiving care from Licensed Acupuncturists was associated with significant improvements in physical, functional, psycho-emotional, and occupational outcomes compared with before receiving acupuncture treatments.

Project description:BackgroundImproving the effectiveness and efficiency of research informed consent is a high priority. Some express concern about longer, more complex, written consent forms creating barriers to participant understanding. A recent meta-analysis concluded that randomized comparisons were needed.MethodsWe conducted a cluster-randomized non-inferiority comparison of a standard versus concise consent form within a multinational trial studying the timing of starting antiretroviral therapy in HIV+ adults (START). Interested sites were randomized to standard or concise consent forms for all individuals signing START consent. Participants completed a survey measuring comprehension of study information and satisfaction with the consent process. Site personnel reported usual site consent practices. The primary outcome was comprehension of the purpose of randomization (pre-specified 7.5% non-inferiority margin).Results77 sites (2429 participants) were randomly allocated to use standard consent and 77 sites (2000 participants) concise consent, for an evaluable cohort of 4229. Site and participant characteristics were similar for the two groups. The concise consent was non-inferior to the standard consent on comprehension of randomization (80.2% versus 82%, site adjusted difference: 0.75% (95% CI -3.8%, +5.2%)); and the two groups did not differ significantly on total comprehension score, satisfaction, or voluntariness (p>0.1). Certain independent factors, such as education, influenced comprehension and satisfaction but not differences between consent groups.ConclusionsAn easier to read, more concise consent form neither hindered nor improved comprehension of study information nor satisfaction with the consent process among a large number of participants. This supports continued efforts to make consent forms more efficient.Trial registrationInformed consent substudy was registered as part of START study in clinicaltrials.gov #NCT00867048, and EudraCT # 2008-006439-12.