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"Gadsden, Jeffrey"
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A phase 3 active-controlled trial of liposomal bupivacaine via sciatic nerve block in the popliteal fossa after bunionectomy
2024
To investigate the efficacy, safety, pharmacodynamics, and pharmacokinetics of liposomal bupivacaine (LB) administered via ultrasound-guided sciatic nerve block in the popliteal fossa in participants undergoing bunionectomy.
Two-part, randomized, double-blind, active-controlled trial (NCT05157841).
Operating room, postanesthesia care unit, and health care facility (6 sites).
Adults with American Society of Anesthesiologists physical status classification ≤3 and body mass index ≥18 to <40 kg/m2 undergoing elective distal metaphyseal osteotomy.
Part A participants were randomized 1:1:1 to LB 266 mg, LB 133 mg, or bupivacaine hydrochloride 50 mg (BUPI). Part B participants were randomized 1:1 to LB (at the dose established by part A) or BUPI.
The primary endpoint was area under the curve (AUC) of numerical rating scale (NRS) pain intensity scores 0–96 h after surgery. Secondary endpoints included total postsurgical opioid consumption, opioid-free status 0–96 h after surgery, and pharmacokinetic endpoints.
Part A enrolled 22 participants per group. In part B, additional participants were randomized to LB 133 mg (n = 59) and BUPI (n = 60) (185 total). LB 133 mg had significant reductions versus BUPI in the AUC of NRS pain intensity score (least squares mean [LSM], 207.4 vs 371.4; P < 0.00001) and total opioid consumption 0–96 h after surgery (LSM, 17.7 [95% confidence interval (CI), 13.7, 22.8] morphine milligram equivalents [MMEs] vs 45.3 [95% CI, 35.1, 58.5] MMEs; P < 0.00001) and an increased proportion of opioid-free participants (24.4% vs 6%; odds ratio, 5.04 [95% CI, 2.01, 12.62]; P = 0.0003) in parts A + B. Adverse events were similar across groups.
LB 133 mg administered via sciatic nerve block in the popliteal fossa after bunionectomy demonstrated superior and long-lasting postsurgical pain control versus BUPI. The clinical relevance of these findings is supported by concurrent reductions in pain and opioid consumption over 4 days after surgery and a significantly greater percentage of participants remaining opioid-free.
[Display omitted]
•This multicenter trial investigated popliteal sciatic nerve blocks for bunionectomy.•Liposomal bupivacaine (LB) was compared with bupivacaine HCl over 96 h.•A robust study design isolated the effects of the popliteal sciatic nerve block.•LB showed reduced pain and opioids compared with bupivacaine HCl over 4 days.•The LB group was significantly more likely to be opioid free vs bupivacaine HCl.
Journal Article
Brachial Plexus Block with Liposomal Bupivacaine for Shoulder Surgery Improves Analgesia and Reduces Opioid Consumption: Results from a Multicenter, Randomized, Double-Blind, Controlled Trial
2020
The utility of single-injection and continuous peripheral nerve blocks is limited by short duration of analgesia and catheter-related complications, respectively. This double-blind, multicenter trial evaluated the efficacy, safety, and pharmacokinetics of single-injection, ultrasound-guided brachial plexus block (BPB) with liposomal bupivacaine (LB) added to a standardized pain management protocol for shoulder surgery.
Adults undergoing total shoulder arthroplasty or rotator cuff repair were randomized to receive LB 133 mg, LB 266 mg (pharmacokinetic and safety analyses only), or placebo, added to a standardized analgesia protocol. The primary end point was area under the curve (AUC) of visual analog scale pain intensity scores through 48 hours postsurgery. Secondary end points were total opioid consumption, percentage of opioid-free patients, and time to first opioid rescue through 48 hours. Pharmacokinetic samples were collected through 120 hours and on days 7 and 10. Adverse events were documented.
One hundred fifty-five patients received treatment (LB 133 mg, N = 69; LB 266 mg, N = 15; placebo, N = 71). BPB with LB 133 mg was associated with significantly improved AUC of pain scores (least squares mean [SE] = 136.4 [12.09] vs 254.1 [11.77], P < 0.0001), opioid consumption (least squares mean [SE] = 12.0 [2.27] vs 54.3 [10.05] mg, P < 0.0001), median time to opioid rescue (4.2 vs 0.6 h, P < 0.0001), and percentage of opioid-free patients (treatment difference = 0.166, 95% confidence interval = 0.032-0.200, P = 0.008) through 48 hours vs placebo. Adverse event incidence was comparable between groups.
Single-injection BPB with LB 133 mg provided analgesia through 48 hours postsurgery with reduced opioid use compared with placebo after shoulder surgery.
Journal Article
Pectoral Fascial (PECS) I and II Blocks as Rescue Analgesia in a Patient Undergoing Minimally Invasive Cardiac Surgery
by
Yalamuri, Suraj
,
Klinger, Rebecca Y
,
Bullock, W Michael
in
Analgesics
,
Breast surgery
,
Case reports
2017
IntroductionPatients undergoing minimally invasive cardiac surgery have the potential for significant pain from the thoracotomy site. We report the successful use of pectoral nerve block types I and II (Pecs I and II) as rescue analgesia in a patient undergoing minimally invasive mitral valve repair.Case ReportIn this case, a 78-year-old man, with no history of chronic pain, underwent mitral valve repair via right anterior thoracotomy for severe mitral regurgitation. After extubation, he complained of 10/10 pain at the incision site that was minimally responsive to intravenous opioids. He required supplemental oxygen because of poor pulmonary mechanics, with shallow breathing and splinting due to pain, and subsequent intensive care unit readmission. Ultrasound-guided Pecs I and II blocks were performed on the right side with 30 mL of 0.2% ropivacaine with 1:400,000 epinephrine. The blocks resulted in near-complete chest wall analgesia and improved pulmonary mechanics for approximately 24 hours. After the single-injection blocks regressed, a second set of blocks was performed with 266 mg of liposomal bupivacaine mixed with bupivacaine. This second set of blocks provided extended analgesia for an additional 48 hours. The patient was weaned rapidly from supplemental oxygen after the blocks because of improved analgesia.ConclusionsPectoral nerve blocks have been described in the setting of breast surgery to provide chest wall analgesia. We report the first successful use of Pecs blocks to provide effective chest wall analgesia for a patient undergoing minimally invasive cardiac surgery with thoracotomy. We believe that these blocks may provide an important nonopioid option for the management of pain during recovery from minimally invasive cardiac surgery.
Journal Article
Practice ‘safe scans’: why ultrasound transducer covers should be considered best practice
2025
Single-injection, ultrasound-guided nerve block procedures involve puncturing the skin in close proximity to an ultrasound transducer, creating a potential vector for transmission of microbial organisms when skin flora and blood come into contact with the probe. Practice patterns regarding disinfection of the transducer and the use of barrier protection are inconsistent, ranging from sterile sleeve probe covers to no cover at all. Although sleeve probe covers are easy and straightforward to use and serve to protect patients, providers and medical equipment, their utilisation remains controversial. Standardisation of their use eliminates the impact of improper or haphazard probe disinfection and makes infection control practices consistent and reproducible. This position is shared by multiple societies and authorities on ultrasound and acute care medicine. In this Daring Discourse, we outline the arguments supporting the utilisation of single-use sleeve probe covers to ensure patient safety with respect to vector-borne transmission of microbes during single-injection regional anaesthesia procedures.
Journal Article
Relationship between injectate volume and disposition in erector spinae plane block: a cadaveric study
2024
IntroductionErector spinae plane (ESP) blocks can be used to provide analgesia following thoracoabdominal and lumbar spine surgical procedures. However, the influence of injectate volume and injection location on the spread of anesthetic with ESP blocks remain unclear.MethodsUltrasound-guided ESP injections were performed on two fresh cadavers using a solution of iopamidol radiographic contrast, indocyanine green or methylene blue dye, and saline. The relationship between injectate volume and cephalocaudal spread was assessed using real-time fluoroscopic recordings after incremental ESP injections to the lumbar and thoracic region. Cadavers were then dissected to expose tissue staining and document the precise disposition of the dye within the ES muscle, paravertebral space, dorsal and ventral rami, and other relevant structures.ResultsLarger injection volumes resulted in more extensive cephalocaudal spread in most cases, with fluoroscopic images revealing a small but direct relationship between injectate volume and contrast spread. Dissection reinforced the radiographic findings, with staining ventral to the ES muscle ranging from 4 to 7 paravertebral levels with injections of 30–40 mL vs 12–13 levels following injections of 60–80 mL. No spread of dye to the lamina, transverse processes, paravertebral space, epidural space, or pleura was observed following any injection.ConclusionsIncreased ESP injection volumes resulted in more extensive cephalocaudal spread, resulting in anesthetic spread to the dorsal rami and ventral ES muscle without involvement of the ventral rami or other anterior structures. Injection volumes of 30 mL may be optimal for ESP blocks requiring analgesia across 4–7 levels.
Journal Article
Flexor digitorum plane block: A novel approach to median and ulnar nerve blockade
2022
In the three right arms, a dye solution of 0.5% methylene blue in 0.9% normal saline was placed in a 10mL syringe and attached to a 2-inch peripheral nerve block needle (Sonoplex, Pajunk, Germany). All three right arms showed dense dye staining of both median and ulnar nerves near the site of injection (Fig. 1b, Table 1). Consistent with our clinical examination findings of a combined median and ulnar nerve block after a single injection was used as a rescue block in PACU, a single injection of methylene blue in the flexor digitorum plane adequately stained both the median and ulnar nerves in cadavers.
Journal Article
Does Ultrasonographic Measurement of Gastric Content Influence Airway Management Decisions?
by
Rice, Andi N
,
Gadsden, Jeffrey C
,
Vacchiano, Charles A
in
Airway Management
,
Anesthesia
,
Clinical decision making
2020
The presence of gastric content before induction of general anesthesia is the primary modifiable risk factor in the prevention of pulmonary aspiration. The purpose of this project was to determine if ultrasonography could be routinely used to measure gastric content and assign aspiration risk in patients undergoing general anesthesia. Preoperative gastric ultrasonography was performed in a convenience sample of 100 patients. A group of Certified Registered Nurse Anesthetists, anesthesia residents, and anesthesiologists were asked their plan for airway management before and after receiving the results of the patients' gastric ultrasonogram, to determine if the scan would alter the plan. In 14% of patients scanned, solid gastric content was observed, 7% had clear liquids present, and 79% had an empty stomach. Of the patients with clear liquids present, 3 had substantial (> 100 mL) gastric content despite following fasting guidelines. Overall, there was a 9% change in airway management from standard induction: 6% changed to modified rapid sequence intubation (no ventilation, no cricoid pressure), and 3% changed to rapid sequence intubation with cricoid pressure. The number of changes to the airway management plan and identification of several patients with substantial gastric content demonstrate the value of preoperative gastric ultrasonography in airway management decision making.
Journal Article
Essentials of Our Current Understanding: Abdominal Wall Blocks
by
Carvalho, Brendan
,
Sharkey, Aidan
,
McDonnell, John G
in
Abdomen
,
Local anesthesia
,
Regional anesthesia
2017
Abdominal wall blocks rely on the spread of local anesthetic within musculofascial planes to anesthetize multiple small nerves or plexuses, rather than targeting specific nerve structures. Ultrasonography is primarily responsible for the widespread adoption of techniques including transversus abdominis plane and rectus sheath blocks, as well as the introduction of novel techniques such as quadratus lumborum and transversalis fascia blocks. These blocks are technically straightforward and relatively safe and reduce pain and opioid requirements in many clinical settings. The data supporting these outcomes, however, can be inconsistent because of heterogeneity of study design. The extent of sensory blockade is also somewhat variable, because it depends on the achieved spread of local anesthetic and the anatomical course of the nerves being targeted. The blocks mainly provide somatic analgesia and are best used as part of a multimodal analgesic regimen. This review summarizes the anatomical, sonographic, and technical aspects of the abdominal wall blocks in current use, examining the current evidence for the efficacy and safety of each.
Journal Article
Use of Near-Infrared Spectroscopy to Measure Tissue Oxygen Saturation During Total Knee Arthroplasty With Use of a Tourniquet
by
Rice, Andi N
,
Gadsden, Jeffrey C
,
Morgan, Brett T
in
Arthroplasty, Replacement, Knee
,
Arthroscopy
,
Female
2019
The primary purpose of this proof-of-concept quality improvement effort was to evaluate the practicality of using near-infrared spectroscopy (NIRS) to measure tissue oxygen saturation (Sto
) during total knee arthroplasty (TKA) with use of a tourniquet. NIRS sensors were applied to the biceps femoris (BF) and gastrocnemius (GS) muscles of both lower extremities of patients undergoing TKA procedures. For a convenience sample of 15 patients, measurement of Sto
was attempted at baseline, following subarachnoid block administration, and after tourniquet inflation and deflation. Mean baseline Sto
(SD) was 71% (6%) in the BF muscle and 66% (7%) in the GS muscle. Significant changes in Sto
values were observed following subarachnoid block, tourniquet inflation, and tourniquet deflation. The Sto
returned to or above baseline in the BF muscle but did not return to baseline in the GS muscle following tourniquet deflation. Changes in tissue oxygen saturation resulting from use of a tourniquet can be continuously monitored with the use of an NIRS device. Further evaluation of the use of NIRS should be undertaken to determine if it could be used to guide safe duration and pressure limits for tourniquet inflation.
Journal Article