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

Abstract

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.

Interventions to improve tolerability of local anesthetic intradetrusor Botulinum toxin injections: A systematic review

“…The studies by Pereira e Silva et al, 28 Kocher et al, 24 and Pedraza Sanchez et al 27 evaluated the effectiveness of lidocaine alkalinized with bicarbonate solution.…”

“…However, there was no standardized measurement for what constituted tolerability. Pain is a subjective experience and influenced by a multitude of factors 28 . Myles et al 36 found 33 mm on a 100 mm VAS to be the upper limit of acceptable pain for postoperative patients.…”

“…The studies by Pereira e Silva et al, 28 Kocher et al, 24 and Pedraza Sanchez et al 27 EMDA enhancement significantly reduced pain scores 21(18.1%) had neurogenic detrusor overactivity (NDO) and 10 (8.6%) were being treated for bladder pain syndrome (BPS). The subjects who had received alkalinized lidocaine solution reported lower pain scores immediately after the procedure than those who received lidocaine solution with saline (NRS 2.37 ± 0.31 and 4.44 ± 0.36, respectively, p < 0.01).…”

“…23 Three studies, including one randomized trial, compared intravesical, alkalinized lidocaine with intraurethral lidocaine gel anesthesia. 24,27,28 While Pedraza Sanchez et al showed some improvement in pain score immediately after the procedure, there was no difference in pain scores an hour later. The other studies did not show any improvement in pain scores with alkalinized lidocaine.…”

“…This review identified three studies that identified that reducing the number of injections reduced pain scores. 20,21,26 The sample size was however small for all three studies (range [25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40]. Two of these studies also assessed whether fewer injections were associated with a reduction in effectiveness.…”