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Journal of Clinical Anesthesia Jun 2024HR18034, composed of the ropivacaine encapsulated in multi-lamellar, concentric circular structure liposomes as the major component and a small amount of free...
Evaluating the efficacy and safety of perianal injection of liposomal ropivacaine HR18034 for postoperative analgesia following hemorrhoidectomy: A multicenter, randomized, double-blind, controlled phase II clinical trial.
STUDY OBJECTIVE
HR18034, composed of the ropivacaine encapsulated in multi-lamellar, concentric circular structure liposomes as the major component and a small amount of free ropivacaine, has performed well in animal experiments and phase I clinical trials. This trial was to investigate the efficacy, safety, pharmacokinetic profile and the minimum effective dose of HR18034 for postoperative analgesia after hemorrhoidectomy compared with ropivacaine.
DESIGN
A multicenter, randomized, double-blind trial.
SETTING
19 medical centers in China.
PATIENTS
85 patients undergoing hemorrhoidectomy between October 2022 to November 2022.
INTERVENTIONS
Patients were randomly divided into HR 18034 190 mg group, 285 mg group, 380 mg group and ropivacaine 75 mg group, receiving single local anesthetic perianal injection for postoperative analgesia.
MEASUREMENTS
The primary outcome was the area under the resting state NRS score -time curve within 72 h after injection. The second outcomes included the proportion of patients without pain, the proportion of patients not requiring rescue analgesia, cumulative morphine consumption for rescue analgesia, etc. Safety was evaluated by adverse events incidence and plasma ropivacaine concentrations were measured to explore the pharmacokinetic characteristics of HR18034.
MAIN RESULTS
The areas under the NRS score (at rest and moving states)-time curve were significantly lower in HR 18034 380 mg group than ropivacaine 75 mg at 24 h, 48 h, and 72 h after administration. However, this superiority was not observed in HR18034 190 mg group and 285 mg group. There was no difference in cumulative morphine consumption for rescue analgesia between HR 18034 groups and ropivacaine group.
CONCLUSIONS
HR 18034 380 mg showed superior analgesic efficacy and equivalent safety compared to ropivacaine 75 mg after hemorrhoidectomy, thus preliminarily determined as minimum effective dose.
PubMed: 38941870
DOI: 10.1016/j.jclinane.2024.111524 -
Medicine Jun 2024Combining hydromorphone with ropivacaine in ultrasound-guided erector spinae plane blocks enhances postoperative analgesia and reduces interleukin-6 expression in breast... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Combining hydromorphone with ropivacaine in ultrasound-guided erector spinae plane blocks enhances postoperative analgesia and reduces interleukin-6 expression in breast surgery patients.
METHODS
In this study, breast cancer patients undergoing modified radical mastectomy were randomized into 3 groups for anesthesia (30 patients in each group): standard general (group C), Erector Spinae Plane Block (ESPB) with ropivacaine (group R), and ESPB with ropivacaine plus hydromorphone (group HR). Diagnosis: Breast cancer patients. Postsurgery, pain levels, IL-6, anesthetic doses, additional analgesia needs, and recovery milestones were compared to evaluate the efficacy of the ESPB enhancements.
RESULTS
The 3 groups were not significantly different in baseline characteristics, operation time, number of cases with postoperative nausea, and serum IL-6 concentrations at T1 (the time of being returned to the ward after surgery). At T2 (at 6:00 in the next morning after surgery), the serum IL-6 concentration in group HR was significantly lower than that in groups R and C (P < .05); the intraoperative doses of remifentanil, sufentanil, and propofol were significantly lower in groups HR and R than those in group C (P < .05); Groups HR and R had significantly lower visual analog scale scores at T3 (4 hours postoperatively), T4 (12 hours postoperatively), and T5 (24 hours postoperatively) than those in group C (P < .05); the proportions of patients receiving postoperative remedial analgesia were significantly lower in groups HR and R than in group C (P < .05); groups HR and R had significantly lower proportions of patients with postoperative nausea than group C (P < .05); the time to the first anal exhaust and the time to the first ambulation after surgery were significantly shorter in groups HR and R than those in group C (P < .05).
CONCLUSION
Hydromorphone combined with ropivacaine for ESPB achieved a greater postoperative analgesic effect for patients receiving MRM under general anesthesia. The combined analgesia caused fewer adverse reactions and inhibited the expression level of the inflammatory factor IL-6 more effectively, thereby facilitating postoperative recovery. ESPB using hydromorphone with ropivacaine improved pain control post-MRM, reduced adverse effects, and more effectively suppressed IL-6, enhancing recovery.
Topics: Humans; Ropivacaine; Female; Hydromorphone; Middle Aged; Nerve Block; Pain, Postoperative; Prospective Studies; Anesthetics, Local; Breast Neoplasms; Mastectomy, Modified Radical; Analgesics, Opioid; Adult; Interleukin-6; Paraspinal Muscles; Ultrasonography, Interventional; Drug Therapy, Combination; Pain Measurement
PubMed: 38941366
DOI: 10.1097/MD.0000000000038758 -
Journal of Anesthesia Jun 2024This study aimed to determine whether the administration of a modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) could result in the blockade...
The key to success in blocking lateral cutaneous branches with re-modified thoracoabdominal nerves block through perichondrial approach: a newly discovered space between the endothoracic fascia, diaphragm, and costodiaphragmatic recess.
PURPOSE
This study aimed to determine whether the administration of a modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) could result in the blockade of the lateral cutaneous branches. This study focused on a newly discovered anatomical space/plane adjacent to the M-TAPA plane, which we termed "space between the endothoracic fascia, diaphragm, and costodiaphragmatic recess: SEDIC."
METHODS
Thirteen sides of nine formalin-embalmed cadavers were macroscopically dissected to investigate the anatomical spaces related to the effects of M-TAPA. Furthermore, ten adult volunteers were administered 20 mL of 0.2% ropivacaine into the abdominal plane (corresponding to the M-TAPA plane) and the SEDIC, and a pinprick test was performed 1 h after the injection.
RESULTS
Cadaver macrodissection revealed the presence of the SEDIC adjacent to the M-TAPA plane. The SEDIC was completely spatially isolated from the M-TAPA plane by the presence of costal cartilage and/or tendinous structures. In the volunteer study, the administration of local anesthetics into the SEDIC effectively blocked the lateral cutaneous branches of T8-T12, in addition to the anterior branches.
CONCLUSION
Our study revealed the presence of the SEDIC adjacent to the M-TAPA plane. Administration of local anesthetics into the SEDIC, named re-modified TAPA, may have the potential to enhance the analgesic effect in the abdominal region.
PubMed: 38940927
DOI: 10.1007/s00540-024-03366-w -
Open Veterinary Journal May 2024During electrochemotherapy (ECT), a chemotherapeutic drug is injected into the tumor and then an electroporation is provided. In horses, ear manipulation may be very...
BACKGROUND
During electrochemotherapy (ECT), a chemotherapeutic drug is injected into the tumor and then an electroporation is provided. In horses, ear manipulation may be very painful, and combining a loco-regional technique with sedation might be a good option to avoid anesthesia-related risks. A two-injection-point block of the internal and external pinna and acoustic meatus was described in horse cadavers, and it permitted complete stain of all three branches of the great auricular nerve (GAN), internal auricular nerve branch (IAB), lateral auricular branch (LAB), and caudal auricular nerve (CAN), suggesting a lower risk of intra-parotid injection during the IAB and LAB block.
CASE DESCRIPTION
An 8-year-old Italian jumping gelding presented for ECT to treat a fibroblastic sarcoid in the left medial pinna. After intravenous sedation with acepromazine, romifidine, and butorphanol, a two-injection-point block was provided as previously described. The block of the GAN was blind, whereas an electrical nerve locator was used for the IAB, LAB, and CAN. A total of 12 ml of 0.5% ropivacaine was injected. The ECT was safely performed without any difficulties. The horse well tolerated the procedure and completely recovered 75 minutes after sedation. No complications were detected.
CONCLUSION
The described approach seems feasible and suitable for the blockade of the sensory innervation of the equine ear in the case of ECT.
Topics: Horses; Animals; Horse Diseases; Male; Electrochemotherapy; Pain; Ropivacaine; Anesthetics, Local; Nerve Block
PubMed: 38938434
DOI: 10.5455/OVJ.2024.v14.i5.26 -
Journal of Personalized Medicine Jun 2024Posterior spinal fusion for adolescent idiopathic scoliosis (AIS) causes severe postoperative pain. Thoracic paravertebral block (PVB) provides excellent analgesia...
Posterior spinal fusion for adolescent idiopathic scoliosis (AIS) causes severe postoperative pain. Thoracic paravertebral block (PVB) provides excellent analgesia during various surgeries. We examined the effects of PVB on postoperative analgesia in children undergoing AIS surgery. In this study, 32 children scheduled for AIS surgery were randomly assigned to receive either PVB (PVB group) or no block (control group). The PVB group underwent surgeon-performed PVB with 0.5 mL/kg of adrenalized 0.2% ropivacaine on each side. The primary outcome was the pain score at rest at 6 h postoperatively. Secondary outcomes included pain scores both at rest and during movement and analgesic use for 48 h postoperatively. The postoperative resting pain scores at 6 h were comparable between the control and PVB groups (5.2 ± 2.0 and 5.1 ± 1.8, respectively), with no significant differences. However, at 1 h postoperatively, the control group showed significantly higher resting and mean moving pain scores than the PVB group ( < 0.05). The pain scores at other time points and analgesic use were comparable between the groups. Initial benefits of surgeon-performed bilateral PVB were observed but diminished at 6 h postoperatively. Future research using various anesthetics is needed to extend the effects of PVB.
PubMed: 38929880
DOI: 10.3390/jpm14060659 -
Regional Anesthesia and Pain Medicine Jun 2024Current understanding of the mechanism of action of the pericapsular nerve group (PENG) block is primarily based on cadaver studies. We performed an imaging study in...
BACKGROUND
Current understanding of the mechanism of action of the pericapsular nerve group (PENG) block is primarily based on cadaver studies. We performed an imaging study in patients undergoing hip surgery to enhance the understanding of the analgesic mechanisms following a PENG block.
MATERIALS AND METHODS
10 patients scheduled for hip surgery received an ultrasound-guided PENG block with 18 mL of 0.5% ropivacaine mixed with 2 mL of a contrast agent. After completion of the block, a high-resolution CT scan was performed to obtain a three-dimensional reconstruction of the injectate's dispersion.
RESULTS
The CT imaging revealed that injectate was mainly confined to the epimysium of the iliacus and the psoas muscle, with a minor spread to the hip capsule. Contrast dye was detected within the iliacus and/or the psoas muscle in all patients. No observed spread to either the subpectineal plane or the obturator foramen was detected.
CONCLUSION
Our study suggests that the analgesic effect of the PENG block may be related to the block of the branches of the femoral nerve traveling within the iliopsoas muscle without a spread pattern commensurate with the block of the obturator nerve.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov Registry (NCT06062134).
PubMed: 38925712
DOI: 10.1136/rapm-2024-105459 -
International Journal of Pharmaceutics Jun 2024Currently, to overcome the short half-life of the local anesthetic ropivacaine, drug delivery systems such as nanoparticles and liposomes have been used to prolong the...
Currently, to overcome the short half-life of the local anesthetic ropivacaine, drug delivery systems such as nanoparticles and liposomes have been used to prolong the analgesic effect, but they are prone to abrupt release from the site of administration or have poor slow-release effects, which increases the risk of cardiotoxicity. In this study, injectable lipid suspensions based on ropivacaine-docusate sodium hydrophobic ion pairing (HIP) were designed to significantly prolong the duration of analgesia. The resulting ion-paired lipid suspension (HIP/LIPO) had a micrometer scale and a high zeta potential, which facilitates stable in situ retention. The strong interaction between docusate sodium and ropivacaine was verified using thermal and spectroscopic analyses, and the formation of micron-sized polymorphic vesicles was attributed to the mutual stabilizing interactions between ropivacaine-docusate sodium HIP, docusate sodium and lecithin. The HIP/LIPO delivery system could maintain drug release for more than 5 days in vitro and achieve high analgesic efficacy for more than 10 days in vivo, reducing the side effects associated with high drug doses. The stable HIP/LIPO delivery system is a promising strategy that offers a clinically beneficial alternative for postoperative pain management and other diseases.
PubMed: 38925241
DOI: 10.1016/j.ijpharm.2024.124378 -
Journal of Anaesthesiology, Clinical... 2024Moderate-to-severe intensity pain is reported on the first day following lower abdominal surgery. No study has compared transversus abdominis plane (TAP) block with...
BACKGROUND AND AIMS
Moderate-to-severe intensity pain is reported on the first day following lower abdominal surgery. No study has compared transversus abdominis plane (TAP) block with retrolaminar block (RLB) in laparoscopic inguinal hernia surgery for postoperative pain relief.
MATERIAL AND METHODS
In this prospective, randomized trial, 42 patients of American Society of Anesthesiologists (ASA) physical status I and II, aged 18-65 s, and having a BMI <40 kgm received TAP or RLB following laparoscopic inguinal hernia surgery. A standard general anesthetic technique was performed. Patients were randomized into two groups: single-shot TAP block (gp I) (n 21) or the RLB (gp II) (n 21) with bilateral 20 ml of 0.375% ropivacaine. Postoperatively, IV paracetamol 1 was administered as rescue analgesia. Postoperative cumulative Visual Analogue Scale (VAS) score 24 hours after surgery was considered as the primary outcome.
RESULTS
Postoperative cumulative VAS score at rest at 24 , represented as mean ± S.D (95% CI), in the TAP block group was 3.54 3.04 2.16-4.93) and in the RLB group was 6.09 4.83 3.89-8.29). value was 0.112 and VAS on movement was 7.95 3.41 6.39-9.50 [2.5-15.0]) in TAP block group, whereas value was 0.110 and VAS on movement was 10.83 5.51 8.32-13.34) in the RLB group.
CONCLUSION
Similar postoperative cumulative pain score on movement at 24 was present in patients receiving TAP block or RLB. However, VAS score at rest and on movement was reduced in patients receiving TAP block at 18 and 24 postoperatively.
PubMed: 38919452
DOI: 10.4103/joacp.joacp_424_22 -
Journal of Anaesthesiology, Clinical... 2024Although thoracic paravertebral blockade (TPVB) is employed in thoracic surgery to ensure satisfactory postoperative analgesia, large doses of anesthetics are required...
BACKGROUND AND AIMS
Although thoracic paravertebral blockade (TPVB) is employed in thoracic surgery to ensure satisfactory postoperative analgesia, large doses of anesthetics are required and manifestations of local anesthetic systemic toxicity (LAST) may appear. Currently, there are limited data on the pharmacokinetics of ropivacaine after continuous TPVB. The aim of this prospective study was to investigate ropivacaine kinetics, in the arterial and venous pools, after continuous TPVB and assess the risk of LAST.
MATERIAL AND METHODS
Immediately after induction of general anesthesia, an ultrasound-guided continuous TPVB at T5 or T6 or T7 thoracic level was performed in 18 adult patients subjected to open thoracotomy. A 25-ml single bolus injection of ropivacaine 0.5% was administered through thoracic paravertebral catheter, followed by a 14 ml/h continuous infusion of ropivacaine 0.2% starting at the end of surgery. Quantification of total ropivacaine concentrations was performed using a validated high-performance liquid chromatography method. Population pharmacokinetic models were developed separately for arterial and venous ropivacaine data.
RESULTS
The best model was one-compartment disposition with an additional pre-absorption compartment corresponding to thoracic paravertebral space. Gender had a significant effect on clearance, with females displaying lower elimination than males. Some patients had ropivacaine concentrations above the toxic threshold, but none displayed evidence of LAST. Continuous thoracic paravertebral nerve blocks provided adequate postoperative analgesia.
CONCLUSION
Ropivacaine doses at the upper end of clinical use (800 mg/d) did not inflict the manifestations of LAST and provided adequate postoperative pain control. Pharmacokinetic models were developed, and the effect of gender was identified.
PubMed: 38919447
DOI: 10.4103/joacp.joacp_353_22 -
Journal of Anaesthesiology, Clinical... 2024
PubMed: 38919438
DOI: 10.4103/joacp.joacp_352_22