Daiki Nemoto1, Sho Suzuki2, Hideki Mori3, Shinichi Katsuki4, Tomoyuki Iwaki5, Masato Aizawa1, Yoji Takeuchi2, Toshio Uraoka3, Tomoki Matsuda5, Tomoki Fujita4, David G Hewett6, Kazutomo Togashi1. 1. Department of Coloproctology, Aizu Medical Center, Fukushima Medical University, Fukushima, Japan. 2. Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan. 3. Department of Gastroenterology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan. 4. Department of Gastroenterology, Otaru Ekisaikai Hospital, Hokkaido, Japan. 5. Department of Endoscopy, Sendai Kousei Hospital, Miyagi, Japan. 6. Faculty of Medicine, the University of Queensland, Brisbane, Australia.
Abstract
OBJECTIVES:Colonic spasm can interfere with colonoscopy, but antispasmodic agents can cause complications. This study aimed to assess the inhibitory effect of topical lidocaine compared with a placebo control. METHODS:In five tertiary-care hospitals in Japan, 128 patients requiring endoscopic resection of a colorectal lesion were enrolled and randomly and double-blindly allocated to colonoscopy with topical administration of 2% lidocaine solution 20mL (LID, n = 64) or normal saline 20mL (control, n = 64). During colonoscopy, the assigned solution was applied with a spray catheter near the lesion and the area was observed for three minutes. primary endpoint was the inhibitory effect at three time-points (1, 2 and 3 minutes after dispersion), using a three-point scale (excellent, fair, poor). Secondary endpoints were rebound spasm and adverse events. All endpoints were scored in real time. Serum lidocaine levels were measured in 32 patients (LID 16, control 16). RESULTS: There were no significant differences between groups in patient demographics. At all time-points, the proportion of patients with "excellent" scores was greater in LID group than control group, with significant differences observed at 2 minutes (p = 0.02) and 3 minutes (p = 0.02). In LID group, the rate of "excellent" scores increased by 12.5% at 2 minutes and was maintained at 3 minutes. Rebound spasm did not occur in LID group, compared with 15.6% of control group (p = 0.001). There were no adverse events in LID group. All serum lidocaine levels were below detectable levels. CONCLUSIONS:Topical lidocaine is an effective and safe method for suppressing colorectal spasm during colonoscopy (UMIN000024733).
RCT Entities:
OBJECTIVES:Colonic spasm can interfere with colonoscopy, but antispasmodic agents can cause complications. This study aimed to assess the inhibitory effect of topical lidocaine compared with a placebo control. METHODS: In five tertiary-care hospitals in Japan, 128 patients requiring endoscopic resection of a colorectal lesion were enrolled and randomly and double-blindly allocated to colonoscopy with topical administration of 2% lidocaine solution 20mL (LID, n = 64) or normal saline 20mL (control, n = 64). During colonoscopy, the assigned solution was applied with a spray catheter near the lesion and the area was observed for three minutes. primary endpoint was the inhibitory effect at three time-points (1, 2 and 3 minutes after dispersion), using a three-point scale (excellent, fair, poor). Secondary endpoints were rebound spasm and adverse events. All endpoints were scored in real time. Serum lidocaine levels were measured in 32 patients (LID 16, control 16). RESULTS: There were no significant differences between groups in patient demographics. At all time-points, the proportion of patients with "excellent" scores was greater in LID group than control group, with significant differences observed at 2 minutes (p = 0.02) and 3 minutes (p = 0.02). In LID group, the rate of "excellent" scores increased by 12.5% at 2 minutes and was maintained at 3 minutes. Rebound spasm did not occur in LID group, compared with 15.6% of control group (p = 0.001). There were no adverse events in LID group. All serum lidocaine levels were below detectable levels. CONCLUSIONS: Topical lidocaine is an effective and safe method for suppressing colorectal spasm during colonoscopy (UMIN000024733).
Authors: James Y Han; Zain Moosvi; Erica Duh; Sunhee Park; Gregory C Albers; Jason B Samarasena; William Karnes Journal: Dig Dis Sci Date: 2020-06-09 Impact factor: 3.199