Delving into the Latest Updates on Lidocaine/Sodium bicarbonate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

PSD 597, PSD-597

Target

SCNA

Action

modulators

Mechanism

SCNA modulators(Sodium channel alpha subunit modulators)

Therapeutic Areas

Urogenital DiseasesOther Diseases

Active Indication-

Inactive Indication

Cystitis, Interstitial

Originator Organization

Plethora Solutions Ltd.

Active Organization-

Inactive Organization

Plethora Solutions Ltd.

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC14H22N2O

InChIKeyNNJVILVZKWQKPM-UHFFFAOYSA-N

CAS Registry137-58-6

View All Structures (2)

Researchers will compare the effects of lidocaine versus air, as a way to fill the breathing tube cuff which is gently inflated to hold in place the trachea (airway) during surgery. Air is the traditional method used to inflate the breathing tube cuff. Researchers wish to find if lidocaine works better than air to facilitate tolerance to the breathing tube (decreased coughing, sore throat, hoarseness). They also want to learn more about its effectiveness for this particular surgical intervention.

Start Date27 Jul 2018

Sponsor / Collaborator

Mayo Clinic

IRCT201709199014N186

/ RecruitingPhase 2IIT

Comparison of the effect of lidocaine-bicarbonate, lidocaine-dexamethasone and lidocaine alone for digital block in patients with figure injury: a double blind randomized clinical trial

Start Date28 May 2017

Sponsor / Collaborator-

NCT03107754

/ CompletedPhase 4IIT

Buffered Lidocaine for Paracervical Block to Decrease Injection Pain During First Trimester Uterine Aspirations

For pain relief during a first trimester surgical aspiration, most providers use the paracervical block, either alone or in combination with other pain control techniques. Some providers use buffered lidocaine due to a belief that it decreases pain. Others use plain lidocaine. At our clinics, the standard pain management protocol is using 20 cc of 1% plain lidocaine in a two site injection. Few studies have compared buffered versus unbuffered lidocaine for paracervical blocks during first trimester uterine aspirations. This study seeks to determine if buffered lidocaine decreases injection pain versus plain lidocaine for paracervical blocks.

Start Date15 May 2017

Sponsor / Collaborator

University of Hawaii System

100 Clinical Results associated with Lidocaine/Sodium bicarbonate

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100 Translational Medicine associated with Lidocaine/Sodium bicarbonate

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100 Patents (Medical) associated with Lidocaine/Sodium bicarbonate

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2

Literatures (Medical) associated with Lidocaine/Sodium bicarbonate

01 Sep 2017·Journal of the American College of Radiology : JACRQ2 · MEDICINE

Impact of Sodium Bicarbonate-Buffered Lidocaine on Patient Pain During Image-Guided Breast Biopsy

Q2 · MEDICINE

Article

Author: Shelby, Rebecca A ; Soo, Mary Scott C ; Vasan, Alison ; Baker, Jay A

PURPOSE:

This randomized, double-blind controlled study evaluated the effectiveness of sodium bicarbonate-buffered lidocaine on reducing pain during imaging-guided breast biopsies.

MATERIALS AND METHODS:

This prospective, HIPAA-compliant study randomly assigned 85 women undergoing ultrasound- or stereotactic-guided core-needle breast biopsies to receive intradermally and intraparenchymally either 1% lidocaine buffered with sodium bicarbonate (9:1 ratio) (bicarbonate study group) or 1% lidocaine alone (control group). Pain was evaluated using a 0-to-10 Likert pain scale during both intradermal and intraparenchymal anesthesia injections and during tissue sampling. Prebiopsy breast pain, anxiety, medical history, demographics, biopsy type, radiologist level of training, breast density, and lesion histology were recorded. Data were analyzed using analysis of variance and analysis of covariance.

RESULTS:

Unadjusted mean pain scores were 1.47 and 2.07 (study and control groups, respectively; P = .15) during intradermal injections, and 1.84 and 2.98 (study and control groups, respectively; P = .03) during intraparenchymal injections. Tissue sampling mean pain scores were .81 and 1.71 (study and control groups, respectively; P = .07). Moderator analyses found (1) among patients with preprocedural pain, those in the bicarbonate group experienced less intradermal injection pain (0.85 ± 1.23) than patients in the control group (2.50 ± 2.09); (2) among patients with fatty or scattered fibroglandular tissue, those in the bicarbonate group (1.35 ± 1.95) experienced less intraparenchymal injection pain than the control group (3.52 ± 3.13); and (3) during ultrasound-guided biopsies, patients in the bicarbonate group experienced less tissue-sampling pain (0.23 ± 0.63) than the control group (1.79 ± 3.05).

CONCLUSIONS:

Overall, buffering lidocaine with sodium bicarbonate significantly reduced pain during intraparenchymal injections, and additional pain reduction was found in certain patient subgroups during intradermal injections, intraparenchymal injections, and tissue sampling.

01 Apr 2009·BJU internationalQ2 · MEDICINE

Intravesical alkalinized lidocaine (PSD597) offers sustained relief from symptoms of interstitial cystitis and painful bladder syndrome

Q2 · MEDICINE

Article

Author: Nickel, J. Curtis ; Moldwin, Robert ; Lee, Soledad ; Davis, Edward L. ; Henry, Richard A. ; Wyllie, Michael G.

OBJECTIVE:

To assess the immediate and sustained relief of the symptoms of interstitial cystitis/painful bladder syndrome (IC/PBlS) after a consecutive 5‐day course of treatment with intravesical alkalinized lidocaine (PSD597), and to characterize the pharmacokinetics of single and multiple doses of intravesical PSD597 in a subgroup of patients.

PATIENTS AND METHODS:

In all, 102 adult patients (99 women) with a clinical diagnosis of IC/PBlS were randomized from 19 centres in the USA and Canada to receive a daily intravesical instillation of PSD597 (200 mg lidocaine, alkalinized with a sequential instillation of 8.4% sodium bicarbonate solution, to a final volume of 10 mL) or placebo (double‐blind), for 5 consecutive days. Patients were followed at intervals up to 29 days after the first instillation. Efficacy was assessed by changes in the Global Response Assessment (GRA), Likert scales for bladder pain, urgency and frequency, and validated O’Leary‐Sant IC symptom and problem indices.

RESULTS:

Significantly more patients treated with PSD597 rated their overall bladder symptoms as moderately or markedly improved on the GRA scale 3 days after completing the 5‐day course of treatment (30% and 9.6%, respectively, for patients treated with PSD597 and placebo;P = 0.012). The treatment effects were also maintained beyond the end of treatment and are further supported by the secondary endpoints, including symptom and problem indices. The peak serum lidocaine concentration during the study was <2 µg/mL, and well below the toxic level (>5 µg/mL).

CONCLUSION:

This preliminary study showed that PSD597 was effective for providing sustained amelioration of symptoms of IC/PBlS beyond the acute treatment phase. The drug was safe, well tolerated and devoid of the systemic side‐effects often experienced with oral drug administration. Long‐term studies are needed to determine the optimum regimen to maintain this favourable treatment effect.

100 Deals associated with Lidocaine/Sodium bicarbonate

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Cystitis, Interstitial	Phase 2	-	Plethora Solutions Ltd.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03107754 (CTgov)	Phase 4	Pain	98	Lidocaine (Standard Paracervical Block)	cnxyvysbwm(skbtkmggdz) = ukbimmigck ummfylskai (dnxvbpnxau, ursuawgdqu - xfhdwjwozt) View more	-	15 May 2020
				Lidocaine-Sodium Bicarbonate (Buffered Lidocaine Paracervical Block)	cnxyvysbwm(skbtkmggdz) = mlekniidsn ummfylskai (dnxvbpnxau, frtsxqfwiv - qnohtvnybi) View more
Pubmed \| J Am Coll Radiol	Not Applicable	-	85	1% lidocaine buffered with sodium bicarbonate (9:1 ratio)	oblpdtidpv(nahvtnyldw) = ruvylwyggl khqaugfrjo (gswqjohnro )	Positive	01 Sep 2017
				1% lidocaine alone	oblpdtidpv(nahvtnyldw) = jvekjngzsx khqaugfrjo (gswqjohnro ) View more