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12 result(s) for "Abramson, Wendy B."
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Percutaneous auricular neuromodulation to treat pain after ambulatory breast surgery: A randomized, double-masked, sham-controlled pilot study
Percutaneous auricular neuromodulation involves implanting electrodes around the ear and administering an electric current. A device is currently available that is cleared to treat symptoms from opioid withdrawal, and multiple reports suggest a possible postoperative analgesic effect. This randomized, controlled pilot study aimed to (1) assess the feasibility of a postoperative auricular neuromodulation protocol and (2) provide an estimate of its treatment effects on postoperative pain and opioid consumption. Adults undergoing unilateral or bilateral ambulatory breast surgery with anticipated moderate-severe pain and a single-injection paravertebral nerve block(s) received an auricular neuromodulation device (NSS-2 Bridge, Masimo) following surgery. Participants were randomized to 5 days of electrical stimulation or sham in a double-masked fashion. In the first 5 days, the median pain for those receiving active stimulation ( = 15) was 0 (interquartile range [IQR] = 0, 0.5] versus 1.5 (IQR = 0, 3.8) for the sham group ( = 15, = 0.084). Concurrently, the median oxycodone use for active stimulation was 0 mg (IQR = 0, 2.5) compared to 0 mg (IQR = 0, 3) for the sham group ( = 0.905). Various secondary outcomes reached statistical significance, including maximum and average daily pain scores. This pilot study demonstrates that percutaneous auricular neuromodulation is a feasible approach for managing pain in ambulatory surgical procedures and shows potential as an effective analgesic following discharge. Considering its ease of application, absence of systemic side effects, and lack of significant complications, conducting a definitive clinical trial seems justified because the current study was underpowered, which possibly resulted in the lack of statistical significance for the primary outcome. : Clinicaltrials.gov NCT05521516.
Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: Neuromodulation of the Sciatic Nerve for Postoperative Analgesia Following Ambulatory Foot Surgery, a Proof-of-Concept Study
Background and ObjectivesPercutaneous peripheral nerve stimulation (PNS) is an analgesic modality involving the insertion of a lead through an introducing needle followed by the delivery of electric current. This modality has been reported to treat chronic pain as well as postoperative pain the day following knee surgery. However, it remains unknown if this analgesic technique may be used in ambulatory subjects following foot procedures beginning within the recovery room immediately following surgery, and with only short series of patients reported to date, the only available data are derived from strictly observational studies. The purposes of this proof-of-concept study were to demonstrate the feasibility of using percutaneous sciatic nerve PNS to treat postoperative pain following ambulatory foot surgery in the immediate postoperative period and provide the first available data from a randomized controlled study design to provide evidence of analgesic effect.MethodsPreoperatively, an electrical lead (SPRINT; SPR Therapeutics, Inc, Cleveland, Ohio) was percutaneously inserted posterior to the sciatic nerve between the subgluteal region and bifurcation with ultrasound guidance. Following hallux valgus osteotomy, subjects received 5 minutes of either stimulation or sham in a randomized, double-masked fashion followed by a 5-minute crossover period and then continuous stimulation until lead removal on postoperative days 14 to 28.ResultsDuring the initial 5-minute treatment period, subjects randomized to stimulation (n = 4) experienced a downward trajectory in their pain over the 5 minutes of treatment, whereas those receiving sham (n = 3) reported no such change until their subsequent 5-minute stimulation crossover. During the subsequent 30 minutes of stimulation, pain scores decreased to 52% of baseline (n = 7). Three subjects (43%) used a continuous popliteal nerve block for rescue analgesia during postoperative days 0 to 3. Overall, resting and dynamic pain scores averaged less than 1 on the numeric rating scale, and opioid use averaged less than 1 tablet daily with active stimulation. One lead dislodged, 2 fractured during use, and 1 fractured during intentional withdrawal.ConclusionsThis proof-of-concept study demonstrates that percutaneous sciatic nerve PNS is feasible for ambulatory foot surgery and suggests that this modality provides analgesia and decreases opioid requirements following hallux valgus procedures. However, lead dislodgement and fracture are concerns.Clinical Trial RegistrationThis study was registered at Clinicaltrials.gov, identifier NCT02898103.
Ultrasound-guided percutaneous peripheral nerve stimulation: neuromodulation of the suprascapular nerve and brachial plexus for postoperative analgesia following ambulatory rotator cuff repair. A proof-of-concept study
Background and objectivesPercutaneous peripheral nerve stimulation (PNS) is an analgesic modality involving the insertion of a lead through an introducing needle followed by the delivery of electric current. This modality has been reported to treat chronic pain as well as postoperative pain following knee and foot surgery. However, it remains unknown if this analgesic technique may be used in ambulatory patients following upper extremity surgery. The purpose of this proof-of-concept study was to investigate various lead implantation locations and evaluate the feasibility of using percutaneous brachial plexus PNS to treat surgical pain following ambulatory rotator cuff repair in the immediate postoperative period.MethodsPreoperatively, an electrical lead (SPR Therapeutics, Cleveland, Ohio) was percutaneously implanted to target the suprascapular nerve or brachial plexus roots or trunks using ultrasound guidance. Postoperatively, subjects received 5 min of either stimulation or sham in a randomized, double-masked fashion followed by a 5 min crossover period, and then continuous stimulation until lead removal postoperative days 14–28.ResultsLeads (n=2) implanted at the suprascapular notch did not appear to provide analgesia, and subsequent leads (n=14) were inserted through the middle scalene muscle and placed to target the brachial plexus. Three subjects withdrew prior to data collection. Within the recovery room, stimulation did not decrease pain scores during the first 40 min of the remaining subjects with brachial plexus leads, regardless of which treatment subjects were randomized to initially. Seven of these 11 subjects required a single-injection interscalene nerve block for rescue analgesia prior to discharge. However, subsequent average resting and dynamic pain scores postoperative days 1–14 had a median of 1 or less on the Numeric Rating Scale, and opioid requirements averaged less than 1 tablet daily with active stimulation. Two leads dislodged during use and four fractured on withdrawal, but no infections, nerve injuries, or adverse sequelae were reported.ConclusionsThis proof-of-concept study demonstrates that ultrasound-guided percutaneous PNS of the brachial plexus is feasible for ambulatory shoulder surgery, and although analgesia immediately following surgery does not appear to be as potent as local anesthetic-based peripheral nerve blocks, the study suggests that this modality may provide analgesia and decrease opioid requirements in the days following rotator cuff repair. Therefore, it suggests that a subsequent, large, randomized clinical trial with an adequate control group is warranted to further investigate this therapy in the management of surgical pain in the immediate postoperative period. However, multiple technical issues remain to be resolved, such as the optimal lead location, insertion technique, and stimulating protocol, as well as preventing lead dislodgment and fracture.Trial registration number NCT02898103.
Percutaneous auricular neuromodulation (nerve stimulation) for the treatment of pain following total knee arthroplasty: a randomized, double-masked, sham-controlled pilot study
BackgroundPercutaneous auricular nerve stimulation (neuromodulation) is an analgesic technique involving the percutaneous implantation of multiple leads at various points on/around the ear followed by the delivery of electric current using an external pulse generator. A device is currently available within the USA cleared to treat symptoms from opioid withdrawal, and multiple reports suggest a possible postoperative analgesic effect. The current randomized, controlled pilot study was undertaken to (1) determine the feasibility and optimize the protocol for a subsequent definitive clinical trial and (2) estimate the treatment effect of auricular neuromodulation on postoperative pain and opioid consumption following total knee arthroplasty.MethodsWithin the recovery room following primary, unilateral, total knee arthroplasty, an auricular neuromodulation device (NSS-2 Bridge, Masimo, Irvine, California, USA) was applied using three percutaneous leads and one ground electrode. Participants were randomized to 5 days of either electrical stimulation or sham stimulation in a double-masked fashion. Participants were discharged with the stimulator in situ and removed the disposable devices at home. The dual primary treatment effect outcome measures were the cumulative opioid use (oral oxycodone) and the mean of the “average” daily pain measured with the Numeric Rating Scale for the first 5 postoperative days.ResultsDuring the first five postoperative days, oxycodone consumption in participants given active stimulation (n=15) was a median (IQR) of 4 mg (2–12) vs 13 mg (5–23) in patients given sham (n=15) treatment (p=0.039). During this same period, the average pain intensity in patients given active stimulation was a median (IQR) of 2.5 (1.5–3.3) vs 4.0 (3.6–4.8) in those given sham (p=0.014). Awakenings due to pain over all eight postoperative nights in participants given active stimulation was a median (IQR) of 5 (3–8) vs 11 (4–14) in those given sham (p<0.001). No device-related localized cutaneous irritation, systemic side effects, or other adverse events were identified.ConclusionsPercutaneous auricular neuromodulation reduced pain scores and opioid requirements during the initial week after total knee arthroplasty. Given the ease of application as well as the lack of systemic side effects and reported complications, a definitive clinical trial appears warranted.Trial registration number NCT05521516.
Percutaneous auricular neuromodulation (nerve stimulation) for the treatment of pain following cholecystectomy and hernia repair: a randomized, double-masked, sham-controlled pilot study
BackgroundPercutaneous auricular nerve stimulation (neuromodulation) involves implanting electrodes around the ear and administering an electric current. A device is currently available within the USA cleared to treat symptoms from opioid withdrawal, and multiple reports suggest a possible postoperative analgesic effect. The current randomized controlled pilot study was undertaken to (1) determine the feasibility and optimize the protocol for a subsequent definitive clinical trial; and (2) estimate the treatment effect of auricular neuromodulation on postoperative pain and opioid consumption following two ambulatory surgical procedures.MethodsWithin the recovery room following cholecystectomy or hernia repair, an auricular neuromodulation device (NSS-2 Bridge, Masimo, Irvine, California, USA) was applied. Participants were randomized to 5 days of either electrical stimulation or sham in a double-blinded fashion.ResultsIn the first 5 days, the median (IQR) pain level for active stimulation (n=15) was 0.6 (0.3–2.4) vs 2.6 (1.1–3.7) for the sham group (n=15) (p=0.041). Concurrently, the median oxycodone use for the active stimulation group was 0 mg (0–1), compared with 0 mg (0–3) for the sham group (p=0.524). Regarding the highest pain level experienced over the entire 8-day study period, only one participant (7%) who received active stimulation experienced severe pain, versus seven (47%) in those given sham (p=0.031).ConclusionsPercutaneous auricular neuromodulation reduced pain scores but not opioid requirements during the initial week after cholecystectomy and hernia repair. Given the ease of application as well as a lack of systemic side effects and reported complications, a definitive clinical trial appears warranted.Trial registration number NCT05521516.
Robot-assisted laparoscopic nephrectomy: early outcome measures with the implementation of multimodal analgesia and intrathecal morphine via the acute pain service
Purpose The objective of this study was to perform a retrospective cohort analysis, in which we measured the association of an acute pain service (APS)-driven multimodal analgesia protocol that included preoperative intrathecal morphine (ITM) compared to historic controls (i.e., surgeon-driven analgesia protocol without ITM) with postoperative opioid use. Methods This was a retrospective cohort study in which the primary objective was to determine whether there was a decrease in median 24-h opioid consumption (intravenous morphine equivalents [MEQ]) among robotic nephrectomy patients whose pain was managed by the surgical team prior to the APS, versus pain managed by APS. Secondary outcomes included opioid consumption during the 24–48 h and 48–72 h period and hospital length of stay. To create matched cohorts, we performed 1:1 (APS:non-APS) propensity score matching. Due to the cohorts occurring at the different time periods, we performed a segmented regression analysis of an interrupted time series. Results There were 76 patients in the propensity-matched cohorts, in which 38 (50.0%) were in the APS cohort. The median difference in 24-h opioid consumption in the pre-APS versus APS cohort was 23.0 mg [95% CI 15.0, 31.0] ( p  < 0.0001), in favor of APS. There were no differences in the secondary outcomes. On segmented regression, there was a statistically significant drop in 24-h opioid consumption in the APS cohort versus pre-APS cohort ( p  = 0.005). Conclusions The implementation of an APS-driven multimodal analgesia protocol with ITM demonstrated a beneficial association with postoperative 24-h opioid consumption following robot-assisted nephrectomy.
Serratus anterior plane versus paravertebral nerve blocks for postoperative analgesia after non-mastectomy breast surgery: a randomized controlled non-inferiority trial
BackgroundParavertebral and serratus plane blocks are both used to treat pain following breast surgery. However, it remains unknown if the newer serratus block provides comparable analgesia to the decades-old paravertebral technique.MethodsSubjects undergoing unilateral or bilateral non-mastectomy breast surgery were randomized to a single-injection serratus or paravertebral block in a subject-masked fashion (ropivacaine 0.5%; 20 mL unilateral; 16 mL/side bilateral). We hypothesized that (1) analgesia would be non-inferior in the recovery room with serratus blocks (measurement: Numeric Rating Scale), and (2) opioid consumption would be non-inferior with serratus blocks in the operating and recovery rooms. In order to claim that serratus blocks are non-inferior to paravertebral blocks, both hypotheses must be at least non-inferior.ResultsWithin the recovery room, pain scores for participants with serratus blocks (n=49) had a median (IQR) of 4.0 (0–5.5) vs 0 (0–3.0) for those with paravertebral blocks (n=51): 0.95% CI −3.00 to −0.00; p=0.001. However, the difference in morphine equivalents did not reach statistical significance for superiority with the serratus group consuming 14 mg (10–19) vs 10 mg (10–16) for the paravertebral group: 95% CI −4.50 to 0.00, p=0.123. Since the 95% CI lower limit of −4.5 was less than our prespecified margin of −2.0, we failed to conclude non-inferiority of the serratus block with regard to opioid consumption.ConclusionsSerratus blocks provided inferior analgesia compared with paravertebral blocks. Without a dramatic improvement in safety profile for serratus blocks, it appears that paravertebral blocks are superior to serratus blocks for postoperative analgesia after non-mastectomy breast surgery.Trial registration number NCT03860974.
The Implementation of an Acute Pain Service for Patients Undergoing Open Ventral Hernia Repair with Mesh and Abdominal Wall Reconstruction
Introduction In this retrospective cohort single-institutional study, we report the outcomes of implementing a standardized protocol of multimodal pain management with thoracic epidural analgesia via the acute pain service (APS) for patients undergoing ventral hernia repair with mesh placement and abdominal wall reconstruction. Methods The primary outcome evaluated was postoperative 72-h opioid consumption, measured in intravenous morphine equivalents (MEQ). Secondary outcomes included hospital length of stay (LOS) among other outcomes. The two cohorts were the APS versus non-APS group, in which the former cohort had an APS providing epidural and multimodal analgesia and the latter utilized pain management per surgical team, which mostly consisted of opioid therapy. Using1:1 propensity-score-matched cohorts, Wilcoxon signed-rank test was used to calculate the differences in outcomes. A p  < 0.05 was considered statistically significant. Results There were 83 patients, wherein 51 (61.4%) were in the APS group. Between matched cohorts, the non-APS cohort’s median [quartiles] total opioid consumption during the first three days was 85.6 mg MEQs [58.9, 112.8 mg MEQs]. The APS cohort was 31.7 mg MEQs [16.0, 55.3 mg MEQs] ( p  < 0.0001). The non-APS hospital LOS median [quartiles] was 5 days [4, 7 days] versus 4 days [4, 5 days] in the APS group ( p  = 0.01). Discussion A dedicated APS was associated with decreased opioid consumption by 75%, as well as a decreased hospital LOS. We report no differences in ICU length of stay, time to oral intake, time to ambulation or time to urinary catheter removal.
Continuous Adductor Canal Versus Continuous Femoral Nerve Blocks: Relative Effects on Discharge Readiness Following Unicompartment Knee Arthroplasty
BackgroundWe tested the hypothesis that, following unicompartment knee arthroplasty, a continuous adductor canal block decreases the time to reach 4 discharge criteria compared with a continuous femoral nerve block.MethodsSubjects were randomized to either an adductor canal or femoral perineural catheter (2-day ropivacaine 0.2% infusion) in an unmasked fashion. The primary outcome was the time to attain 4 discharge criteria: (1) adequate analgesia; (2) intravenous opioid independence; (3) ability to independently stand, walk 3 m, return, and sit down; and (4) ambulate 30 m.ResultsSubjects with an adductor canal catheter (n = 15) reached all 4 criteria in a median of 35 hours (interquartile range, 24–43 hours), compared with 40 hours (interquartile range, 27–69 hours) for those with a femoral catheter (n = 15; Wilcoxon rank sum test: P = 0.46; log-rank test: P = 0.16). However, the percentages of subjects (adductor canal: femoral) who reached the 2 mobilization criteria were 27%:0% on postoperative day (POD) 0, 93%:53% on POD 1, and 100%:73% on POD 2. Of adductor canal subjects, 100% were discharge ready by POD 2, compared with only 73% of femoral subjects (P < 0.001).ConclusionsCompared with a continuous femoral nerve block, a continuous adductor canal block did not appreciably decrease the median number of hours to overall discharge readiness, yet did decrease the number of discrete days until discharge readiness. These results are applicable to only unicompartment knee arthroplasty and must be considered preliminary because of the limited sample size of this pilot study.
Monitoring and evaluation of contracts for health service delivery in Costa Rica
The Costa Rican Social Security Fund (CCSS) has been purchasing primary health care services from the Costa Rican Cooperative, COOPESALUD. The CCSS has made significant progress in establishing performance indicators and conducting evaluations of progress against those indicators. After laying out a general framework for developing performance indicators, this paper analyzes the CCSS’s evaluation of its 1998 contract with COOPESALUD in terms of objectives, performance indicators, evaluation results, and use of the evaluation results. The objectives of the COOPESALUD contract, as they are stated within the body of the contract, are to increase coverage, improve quality and increase efficiency. Contract performance is measured through three categories of indicators: organization, service delivery and quality. Service delivery targets are set in terms of volume of services based upon geographic population. A ‘yes’ or a ‘no’ rating to indicate whether a particular system is in place is used for scoring organization and quality targets. While the CCSS contract is one of the most advanced in the region, many aspects could be improved. By setting indicator targets based upon population estimates, it is difficult for the CCSS to accurately assess COOPESALUD’s performance. Although the CCSS conducts periodic evaluations through formal mechanisms, and some data on volume of service delivery are available, the data gathered in all three categories do not provide the purchaser with information directly related to all of the contract objectives nor to contractor performance. The indicators spelled out in the contract, and the evaluation of those indicators, do not seek to measure quantifiable results or impact through numerical data. There are no process or result indicators in place. The evaluation results could therefore tend to be fairly superficial – based upon population coverage and not on effectiveness of treatment, quality of treatment or efficient resource use.