Prevention of persistent pain with lidocaine infusions in breast cancer surgery (PLAN): study protocol for a multicenter randomized controlled trial.

BACKGROUND: Persistent pain is a common yet debilitating complication after breast cancer surgery. Given the pervasive effects of this pain disorder on the patient and healthcare system, post-mastectomy pain syndrome (PMPS) is becoming a larger population health problem, especially as the prognosis and survivorship of breast cancer increases. Interventions that prevent persistent pain after breast surgery are needed to improve the quality of life of breast cancer survivors. An intraoperative intravenous lidocaine infusion has emerged as a potential intervention to decrease the incidence of PMPS. We aim to determine the definitive effects of this intervention in patients undergoing breast cancer surgery. METHODS: PLAN will be a multicenter, parallel-group, blinded, 1:1 randomized, placebo-controlled trial of 1,602 patients undergoing breast cancer surgery. Adult patients scheduled for a lumpectomy or mastectomy will be randomized to receive an intravenous 2% lidocaine bolus of 1.5 mg/kg with induction of anesthesia, followed by a 2.0 mg/kg/h infusion until the end of surgery, or placebo solution (normal saline) at the same volume. The primary outcome will be the incidence of persistent pain at 3 months. Secondary outcomes include the incidence of pain and opioid consumption at 1 h, 1-3 days, and 12 months after surgery, as well as emotional, physical, and functional parameters, and cost-effectiveness. DISCUSSION: This trial aims to provide definitive evidence on an intervention that could potentially prevent persistent pain after breast cancer surgery. If this trial is successful, lidocaine infusion would be integrated as standard of care in breast cancer management. This inexpensive, widely available, and easily administered intervention has the potential to reduce pain and suffering in an already afflicted patient population, decrease the substantial costs of chronic pain management, potentially decrease opioid use, and improve the quality of life in patients. TRIAL REGISTRATION: This trial has been registered on clinicaltrials.gov (NCT04874038, Dr. James Khan. Date of registration: May 5, 2021).

Achieving Competency in Fiber-Optic Intubation Among Resident Physicians After Higher- Versus Lower-Fidelity Task Training: A Randomized Controlled Study.

BACKGROUND: The high-fidelity ORSIM (Airway Simulation Ltd) and the low-fidelity wooden-block fiber-optic task trainers allow users to familiarize themselves with the psychomotor skills required to manipulate the fiber-optic scope. METHODS: This single-center study aimed to compare residents' performance of fiber-optic intubation after 2 different types of task training. Twenty-four residents with experience of <8 fiber-optic intubations were randomized to either the ORSIM or a wooden-block task trainer. In a single teaching session, the resident performed 20 fiber-optic intubations on their assigned task trainer. This implied simulator competence. In the 4 months after this training, all subjects then attempted to perform a fiber-optic intubation on an American Society of Anesthesiologists (ASA) I or II anesthetized patient whose airway was preoperatively assessed as normal. The primary outcome was the cumulative sum (CUSUM) learning curves obtained as the residents trained on their respective task trainers. Secondary outcomes included: the mean time (in seconds) to perform each of the 20 fiber-optic intubations on their assigned task trainer, the total simulator training time, global rating scale score, checklist score, and time to carina when performing fiber-optic intubation on the patient. RESULTS: The CUSUM analysis showed that the ORSIM group achieved simulator competence faster. The mean time to perform fiber-optic intubation was shorter in the ORSIM group. A 2-way analysis of variance (ANOVA) test suggests that the combined effect of group (wooden-block or ORSIM) and time is statistically significant ( P < .05).Total training time (mean, 899 s ± 440 s vs 1358 s ± 405 s; 95% confidence interval [CI], 100.46-818.54; P = .01) was also significantly better in the ORSIM group.No significant difference was found between the 2 groups ( P > 0) in terms of global rating scale, checklist score, and time to reach the carina ( P >.05) when performing the fiber-optic intubation on the patient. CONCLUSIONS: ORSIM showed superiority in terms of the CUSUM learning curve in reaching competence faster in fewer attempts. There was no statistically significant difference in residents' performance when translated to clinical practice on a patient. This information should assist course directors when choosing task trainers for fiber-optic intubation training programs.

Does low-dose gapapentin reduce opioid use postoperatively?: A randomized controlled trial in women undergoing reconstructive pelvic surgery.

INTRODUCTION AND HYPOTHESIS: Pre-emptive gabapentin has been shown to decrease postoperative pain in abdominal and vaginal hysterectomy. However, the effect of pre-emptive low-dose gabapentin has not been studied in vaginal hysterectomy combined with concomitant pelvic reconstruction. METHODS: A randomized double-blind placebo-controlled trial assessed all women seen for symptomatic prolapse requiring vaginal hysterectomy with concomitant pelvic reconstruction with or without midurethral sling. Gabapentin dosing was 600 mg (<65 years) or 300 mg (>65 years). The primary outcome was reduction in opioid consumption in the first 24 h after surgery. Secondary outcomes included sedation and prolongation of recovery room stay. Sample-size calculations indicated a need for 22 participants/group. Student's t test was used to compare differences in oral administration of morphine equivalents in the first 24 h postoperatively, time from end of surgery to leaving the recovery room, and length of recovery room stay. Mann-Whitney U test was used to compare visual analog scale (VAS) scores for anxiety, drowsiness/sedation, pain, and nausea. RESULTS: Twenty-one patients received gabapentin and 26 a placebo capsule. Groups were similar with respect to age, menopause status, parity, American Society of Anesthesiologist (ASA) class, and concomitant procedures. There were also no significant differences between groups in opioid requirements within the first 24 h after surgery, time from end of surgery to leaving the recovery room, length of time in recovery room, or VAS scores. CONCLUSIONS: Pre-emptive gabapentin at our institutional low doses did not significantly affect postoperative pain and opioid requirements in women undergoing vaginal hysterectomy with concomitant reconstruction. TRIAL REGISTRATION: www.clinicaltrials.gov , #NCT02999724.

The Effect of Gabapentin on Delayed Discharge from the Postanesthesia Care Unit: A Retrospective Analysis.

BACKGROUND: Enhanced recovery after surgery programs has incorporated gabapentin as part of a multimodal analgesia protocol. The preemptive use of gabapentin was found to be beneficial due to its opioid-sparing effect. However, excessive sedation and delayed discharge from postanesthesia recovery units are of concern. The aim of this study was to investigate whether preoperative gabapentin increased the length of stay in the recovery unit. METHODS: This retrospective cross-sectional study was carried out over a period of 2 months in the postanesthesia care unit (PACU) of a tertiary care hospital in Canada. Two hundred and twenty-eight consecutive patients who underwent elective surgical procedures and who required a longer than 2-hour stay in the PACU were included. Prolonged stays caused by respiratory inadequacy, hemodynamic instability, nausea, vomiting, pain, and loss of consciousness were recorded. The data were collected from patients' charts and nursing flow sheets. RESULTS: All patients were grouped into those who received 300 mg gabapentin (n = 108), 600 mg gabapentin (n = 41), and no gabapentin (n = 139). No significant difference was observed between the groups in terms of opioid consumption, respiratory inadequacy, nausea, vomiting, and hemodynamic parameters. Gabapentin administration groups had significantly lower postoperative pain scores (P < 0.001). Decreased level of consciousness occurred significantly more often in a dose-dependent fashion in the gabapentin groups and led to a longer stay in the PACU (P < 0.001). CONCLUSION: In the setting of enhanced recovery after surgery, gabapentin did reduce pain scores, but at the cost of delayed discharge from the recovery room. Future studies are needed to evaluate the efficacy of gabapentin in this setting.

Physician and Patient Survey of Taper Schedule and Family Physician Letters Following Discharged from the Acute Pain Service.

PURPOSE: Following discharge, patients requiring high opioid doses may be at risk for both under- and overdosing, posing a major challenge to community physicians. The aim of this study was to examine the effectiveness and degree of satisfaction with a personalized taper schedule and physician letter through interviews of patients and physicians. METHODS: This was a 1-year prospective study. Following ethics approval and informed written consent, patients admitted for elective surgery, 18 to 60 years of age, receiving opioid analgesics, were recruited. Prior to discharge, the acute pain service team provided patients with a taper schedule explained in detail. Individualized physician letters were faxed to treating family physicians. Patients were contacted by phone 2, 4, and 6 weeks after discharge. Physicians were contacted once, a month after discharge. Patients and physicians were asked to grade the taper schedule on a 1- to 5-point Likert scale. Questions pertained to clarity, usefulness, ability to follow the instructions, and general satisfaction. RESULTS: Twenty-six patients and 21 physicians completed the study. Physicians were generally satisfied with both the taper schedule and letter and rated all aspects between 3.76 and 4.38 of 5. Similarly, patients were satisfied with the taper schedule and rated all aspects between 4.08 and 4.5. CONCLUSIONS: Both physicians and patients generally found the taper schedule and letter helpful in assisting them to taper off their opioid use. This is one way of bridging the gap in continuity of care between the acute and primary care providers while reducing the risk to patients during the transition period.

Bedside Gastric Ultrasonography in Term Pregnant Women Before Elective Cesarean Delivery: A Prospective Cohort Study.

BACKGROUND: Bedside gastric ultrasound can reliably assess gastric contents in the perioperative period. We aimed to describe the qualitative and quantitative ultrasound assessment of the gastric antrum in fasted pregnant women at term. METHODS: Pregnant women were examined after a minimum period of overnight fasting (solid food, 6 hours; clear liquids, 2 hours) before their scheduled cesarean delivery. A standardized ultrasound examination of the gastric antrum was performed. Based on the qualitative assessment in the supine and right lateral decubitus positions, women were classified using a 3-point grading system (grade 0, no fluid; grade 1, fluid seen in right lateral decubitus position only; and grade 2, fluid seen in the both supine and right lateral decubitus positions). A quantitative assessment of the antral cross-sectional area (CSA) was performed using still images in the right lateral decubitus position. RESULTS: One hundred three women were included in the study; 53 of 103 exhibited grade 0 and 49 of 103 exhibited grade 1 antrum. One woman presented a grade 2 antrum (1/103 = 0.97%; 95% confidence interval [CI], 0.05%-6.06%). Overall, 95% of fasting subjects presented with an antral CSA ≤9.6 cm (95% CI, 8.6-10.3 cm) in the right lateral decubitus position (median [interquartile range] = 4.5 [3.2] cm), corresponding to an estimated gastric volume of ≤117 mL (95% CI, 108-127 mL) or ≤1.5 mL/kg (95% CI, 1.3-1.7 mL/kg). CONCLUSIONS: All women but one presented with antral CSA compatible with residual gastric fluid. The qualitative 3-point grading system may be used to assess individual risk of perioperative gastric content aspiration. Our results suggest that an antral CSA of 10.3 cm in the right lateral decubitus position more accurately describes the upper limit of normal findings in the fasted pregnant patient at term.

The effect of gowning on labor epidural catheter colonization rate: a randomized controlled trial.

BACKGROUND: The need to gown for labor epidural catheter insertion is controversial. The American Society of Regional Anesthesia and Pain Medicine has identified a lack of randomized controlled trials investigating this issue. The purpose of this study was to examine the effect of gowning on colonization rates following epidural catheter insertion for labor analgesia. METHODS: Following research ethics board approval and informed written consent, parturients were randomized to undergo epidural analgesia with the anesthesiologist either ungowned or wearing a sterile gown. Cultures were obtained from each of the operator forearms, the work area under the insertion site, and from the epidural catheter tip as well as from the catheter segment adjacent to the insertion site. The primary outcome was growth of any microbial organisms from the cultured sites. RESULTS: Two hundred fourteen patients completed the study. There were no significant differences in catheter-tip colonization rates between the ungowned and gowned groups (9.2% vs 7.6%, respectively). The most common microorganism that was cultured was coagulase-negative Staphylococcus. CONCLUSIONS: The use of gowns in the current study did not affect catheter colonization rate. Overall, there was a relatively high incidence of catheter-tip colonization in both groups, which underscores the need for strict aseptic technique.

Low-fidelity simulation improves mastery of the aseptic technique for labour epidurals: an observational study.

PURPOSE: The objective of this study was to determine the impact of a low-fidelity simulation model on mastering the sterile technique during placement of epidural catheters. METHODS: Trainees, including residents and fellows, were given conventional teaching consisting of a lecture and a video demonstration on the appropriate sterile technique to apply during the placement of epidural catheters. The trainees were then provided with a one-on-one demonstration session using a low-fidelity Styrofoam™ epidural model, followed by a series of simulation sessions. After conventional teaching and following each simulation session, the trainees were assessed on their performance until competence was achieved based on a 15-point checklist. The retention of competence was subsequently evaluated bi-weekly in clinical practice for four assessments. RESULTS: Twenty-one trainees participated in the study. The average score for the residents following conventional teaching was 6.0 out of 15 points on the checklist. Following the initial one-on-one hands-on demonstration, the average score increased to 10.8 (difference = 4.8, 95% confidence interval (CI): 3.3 to 6.2; P < 0.001). The average score for the fellows following conventional teaching was 7.9 out of 15 points on the checklist. Following the initial one-on-one hands-on demonstration the average score increased to 11.2 (difference = 3.3, 95% CI: 0.05 to 6.6; P = 0.047). During the retention of competence phase, scores ranged from 13-15 for both residents and fellows. CONCLUSION: This study describes a comprehensive teaching model for mastering the sterile technique during epidural catheter placement. It suggests that low-fidelity simulation improves the learning process when used in addition to conventional teaching.

Effect of a preoperative gabapentin on postoperative analgesia in patients with inflammatory bowel disease following major bowel surgery: a randomized, placebo-controlled trial.

BACKGROUND: Postoperative pain management for patients with inflammatory bowel disease (IBD) can be challenging. These patients have a high tolerance to pain medication, and relative contraindications to the use of epidural analgesia, limiting the pain management options. We evaluated the effect of a single preoperative gabapentin dose on opioid consumption for patients with IBD undergoing abdominal surgery. Secondary outcomes were postoperative pain scores, opioid-related side effects, and patient's length of hospital stay. METHODS: Following Research Ethics Board approval and informed written consent, patients were randomly allocated into 2 groups receiving either 600 mg of oral gabapentin or placebo 1 hour before the surgery. A blinded anesthesiologist recorded pain scores at rest and movement twice daily for 2 postoperative days. Also recorded were opioid consumption, time of return of bowel function, time to discharge, and opioid-related side effects on the opioid-related symptom distress scale (ORSDS). RESULTS: Seventy-two patients completed the study. The difference in opioid consumption (P = 0.4169) and pain scores measured at rest and movement on all 4 postoperative visits was not statistically significant. There was no significant difference between gabapentin and placebo on all the 11 symptoms reported on the ORSDS. There was a slight increase in length of hospital stay in the placebo group, but the return of bowel function was similar between the groups. CONCLUSIONS: This study examined the effect of a single preoperative administration of gabapentin in patients with IBD undergoing major bowel surgery. Our results suggest a single preoperative oral dose of gabapentin 600 mg does not reduce postoperative pain scores, opioid consumption, or opioid-related side effects.