Alkalinized lidocaine solution as a first-line local anesthesia protocol for intradetrusor injection of onabotulinum toxin A: Results from a double-blinded randomized controlled trial

被引:15
|
作者
Pereira e Silva, Ricardo [1 ,2 ]
Ponte, Carolina [1 ]
Lopes, Filipe [1 ]
Palma dos Reis, Jose [1 ,2 ]
机构
[1] Ctr Hosp Univ Lisboa Norte, Dept Urol, Lisbon, Portugal
[2] Univ Lisbon, Fac Med, Clin Univ Urol, Lisbon, Portugal
关键词
administration; intravesical; anesthesia; local; urinary bladder; overactive; botulinum toxins; type A; double-blind method; lidocaine; randomized controlled trial; sodium bicarbonate; INTRAVESICAL BOTULINUM-TOXIN; VISUAL ANALOG SCALE; DETRUSOR OVERACTIVITY; URINARY-INCONTINENCE; PAIN INTENSITY; BLADDER; EFFICACY; SYMPTOMS; PHASE-3; SAFETY;
D O I
10.1002/nau.24519
中图分类号
R5 [内科学]; R69 [泌尿科学(泌尿生殖系疾病)];
学科分类号
1002 ; 100201 ;
摘要
Aims Local anesthesia protocols for intradetrusor onabotulinum toxin A (BoNTA) injection lack standardization. We aimed to determine if an alkalinized lidocaine solution is more effective than lidocaine only. Methods Patients of both genders aged 18 or above enlisted for intradetrusor BoNTA injection (idiopathic, neurogenic, and bladder pain syndrome) were included in a double-blinded randomized controlled trial after obtaining their informed consent. All participants filled a bladder diary and a urine culture was performed. Subjects were randomized 1:1 to Protocol A (20 ml 2% lidocaine + 10 ml 8.4% sodium bicarbonate) or Protocol B (20 ml 2% lidocaine + 10 ml 0.9% saline solution). A Numeric Rating Scale (0-10) was used to assess the level of pain immediately after the procedure (primary endpoint). Secondary endpoints included pain after 1 h, urinary tract infection, acute urinary retention, and hematuria related to the procedure. Results A total of 116 patients were randomized. Baseline characteristics (age, sex, indication, and bladder diary parameters) of patients in Group A and B were similar. Pain scores at the end of the procedure were significantly lower with the alkalinized solution (Protocol A and B, respectively, 2.37 +/- 0.31 vs. 4.44 +/- 0.36,p < .01). No differences were observed 1 h after treatment (Protocol A and B, respectively, 0.54 +/- 0.17 vs. 0.69 +/- 0.19,p = .487). The only adverse event reported was mild-to-moderate self-limited hematuria in 15.4% of patients. Conclusions The use of an alkalinized lidocaine solution has proven to be significantly superior to lidocaine only as local anesthesia before intradetrusor BoNTA injection, suggesting that this may be considered a first-line option.
引用
收藏
页码:2471 / 2479
页数:9
相关论文
共 50 条
  • [31] RESULTS FROM A RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE EFFICACY AND SAFETY OF INTRA-TRIGONAL INJECTION OF ONABOTULINUM TOXIN A IN PATIENTS WITH BLADDER PAIN SYNDROME/INTERSTITIAL CYSTITIS.
    Pinto, Rui
    Costa, Daniel
    Morgado, Afonso
    Pereira, Pedro
    Silva, Joao
    Cruz, Francisco
    JOURNAL OF UROLOGY, 2017, 197 (04): : E46 - E46
  • [32] Post-treatment clinical course following botulinum toxin injection therapy for adductor spasmodic dysphonia: Analysis of data from a placebo-controlled, randomized, double-blinded clinical trial in Japan
    Hirose, Kahori
    Asano, Kento
    Sakaguchi, Masahiko
    Nagao, Asuka
    Nakahira, Maya
    Doi, Nao
    Kobayashi, Taisuke
    Hyodo, Masamitsu
    LARYNGOSCOPE INVESTIGATIVE OTOLARYNGOLOGY, 2021, 6 (05): : 1088 - 1095
  • [33] Fluvastatin in the first-line therapy of acute coronary syndrome: results of the multicenter, randomized, double-blind, placebo-controlled trial (the FACS-trial)
    Ostadal, Petr
    Alan, David
    Vejvoda, Jiri
    Kukacka, Jiri
    Macek, Milan
    Hajek, Petr
    Mates, Martin
    Kvapil, Milan
    Kettner, Jiri
    Wiendl, Martin
    Aschermann, Ondrej
    Slaby, Josef
    Holm, Frantisek
    Telekes, Peter
    Horak, David
    Blasko, Peter
    Zemanek, David
    Veselka, Josef
    Cepova, Jana
    TRIALS, 2010, 11
  • [34] Fluvastatin in the first-line therapy of acute coronary syndrome: results of the multicenter, randomized, double-blind, placebo-controlled trial (the FACS-trial)
    Petr Ostadal
    David Alan
    Jiri Vejvoda
    Jiri Kukacka
    Milan Macek
    Petr Hajek
    Martin Mates
    Milan Kvapil
    Jiri Kettner
    Martin Wiendl
    Ondrej Aschermann
    Josef Slaby
    Frantisek Holm
    Peter Telekes
    David Horak
    Peter Blasko
    David Zemanek
    Josef Veselka
    Jana Cepova
    Trials, 11
  • [35] REMOTE ISCHAEMIC PRECONDITIONING ATTENUATES KIDNEY INJURY PERIOPERATIVELY IN PATIENTS UNDERGOING SURGICAL LOWER LIMB REVASCULARISATION: RESULTS FROM A RANDOMIZED DOUBLE-BLINDED CONTROLLED TRIAL
    Kepler, T.
    Kuusik, K.
    Lepner, U.
    Starkopf, J.
    Zilmer, M.
    Eha, J.
    Lieberg, J.
    Kals, J.
    ATHEROSCLEROSIS, 2019, 287 : E104 - E104
  • [36] Design and implementation of botulinum toxin on cricopharyngeal dysfunction guided by a combination of catheter balloon, ultrasound, and electromyography (BECURE) in patients with stroke: study protocol for a randomized, double-blinded, placebo-controlled trial
    Xie, Mengshu
    Dou, Zulin
    Wan, Guifang
    Zeng, Peishan
    Wen, Hongmei
    TRIALS, 2021, 22 (01)
  • [37] Design and implementation of botulinum toxin on cricopharyngeal dysfunction guided by a combination of catheter balloon, ultrasound, and electromyography (BECURE) in patients with stroke: study protocol for a randomized, double-blinded, placebo-controlled trial
    Mengshu Xie
    Zulin Dou
    Guifang Wan
    Peishan Zeng
    Hongmei Wen
    Trials, 22
  • [38] Improvement in Early Scar Maturation by Nanofat Infiltration: Histological and Spectrophotometric Preliminary Results From a Split Scar-Controlled, Randomized, Double-Blinded Clinical Trial
    Ramaut, Lisa
    Moonen, Linde
    Geeroms, Maxim
    Leemans, Gaelle
    Peters, Ellen
    Forsyth, Ramses
    Gutermuth, Jan
    Hamdi, Moustapha
    AESTHETIC SURGERY JOURNAL OPEN FORUM, 2024, 6
  • [39] A phase II randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of simtuzumab (GS-6624) combined with gemcitabine as first-line treatment for metastatic pancreatic adenocarcinoma
    Benson, Al Bowen
    Thai, Zung
    Hawkins, Michael J.
    Werner, Douglas
    Dong, Hua
    Lee, Claudia
    Bendell, Johanna C.
    JOURNAL OF CLINICAL ONCOLOGY, 2013, 31 (15)
  • [40] Botulinum toxin injection into the intrinsic laryngeal muscles to treat spasmodic dysphonia: A multicenter, placebo-controlled, randomized, double-blinded, parallel-group comparison/open-label clinical trial
    Hyodo, Masamitsu
    Nagao, Asuka
    Asano, Kento
    Sakaguchi, Masahiko
    Mizoguchi, Kenji
    Omori, Koichi
    Tada, Yasuhiro
    Hatakeyama, Hiromitsu
    Oridate, Nobuhiko
    Naito, Kensei
    Iwata, Yoshihiro
    Shinomiya, Hirotaka
    Hara, Hirotaka
    Sanuki, Tetsuji
    Yumoto, Eiji
    EUROPEAN JOURNAL OF NEUROLOGY, 2021, 28 (05) : 1548 - 1556