NCT02751346|Completed
Persistent Pain After Cystectomy for Bladder Cancer
Persistent Postsurgical Pain (PPSP) Following Cystectomy: A Survey and Sensory Examination
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Persistent Postsurgical Pain (PPSP) Following Cystectomy: A Survey and Sensory Examination
Sponsor study identifier
observational
383
1 country
1
Study Start
January 2016
Actual (reported)Primary Completion
November 2016
Actual (reported)Study Completion
February 2017
Actual (reported)This single-center, cross-sectional survey and sensory examination is conducted to determine the prevalence, sensory characteristics and risk factors of PPSP in patients who underwent cystectomy at Washington University/Barnes-Jewish Hospital between 2009 and 2015. Based on data from other lower abdominal surgeries, the investigators hypothesize that 10-15% of patients undergoing cystectomy will develop PPSP.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2016
Actual (reported)April 20, 2016
Actual (reported)April 26, 2016
Actual (reported)November 2016
Actual (reported)February 2017
Actual (reported)Ratio of participants reporting PPSP at the time of survey.
Presence of PPSP will be determined based on presence of pain in the pelvic area at the time of survey.
between 3 months to 6 years post surgery
Comparison of sensory findings between patients with PPSP and patients without PPSP after cystectomy. This specific aim will be attained by performing Quantitative Sensory Testing (QST).
1 to 3 months post survey completion
Patients with pain identified through the survey will be invited to undergo sensory assessment by quantitative sensory testing (QST) around the surgical scar and a control area: Thermal (cold and heat) detection and pain thresholds; mechanical detection and pain threshold; dynamic mechanical allodynia; temporal summation (wind-up).
Patients without pain age and gender matched to patients with pain identified through the survey will be invited to undergo sensory assessment by quantitative sensory testing (QST) around the surgical scar and a control area: Thermal (cold and heat) detection and pain thresholds; mechanical detection and pain threshold; dynamic mechanical allodynia; temporal summation (wind-up).
Survey: 383 patients who have undergone cystectomy at Washington University/Barnes-Jewish Hospital. Sensory testing: Considering 25-30% 5-year mortality rate after cystectomy for bladder cancer, we expect 10-15 subjects with PPSP and 10-15 age and gender matched controls to participate in the sensory testing portion.
Washington University in St. Louis
St Louis, Missouri, 63110, United States
Kaufman DS, Shipley WU, Feldman AS. Bladder cancer. Lancet. 2009 Jul 18;374(9685):239-49. doi: 10.1016/S0140-6736(09)60491-8. Epub 2009 Jun 10.
Tang K, Li H, Xia D, Hu Z, Zhuang Q, Liu J, Xu H, Ye Z. Laparoscopic versus open radical cystectomy in bladder cancer: a systematic review and meta-analysis of comparative studies. PLoS One. 2014 May 16;9(5):e95667. doi: 10.1371/journal.pone.0095667. eCollection 2014.
Simon Haroutounian, PhD
Washington University School of Medicine
383 participants (actual enrollment reported by the registry).
First Submitted
April 20, 2016
First Posted
April 26, 2016
Study Start
January 2016
Actual (reported)Primary Completion
Biofeedback Based Virtual Reality Intervention to Manage Postoperative Pain
Contact the study team to confirm eligibility.
Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
Haroutiunian S, Nikolajsen L, Finnerup NB, Jensen TS. The neuropathic component in persistent postsurgical pain: a systematic literature review. Pain. 2013 Jan;154(1):95-102. doi: 10.1016/j.pain.2012.09.010.
McNicol ED, Schumann R, Haroutounian S. A systematic review and meta-analysis of ketamine for the prevention of persistent post-surgical pain. Acta Anaesthesiol Scand. 2014 Nov;58(10):1199-213. doi: 10.1111/aas.12377. Epub 2014 Jul 25.
Andreae MH, Andreae DA. Regional anaesthesia to prevent chronic pain after surgery: a Cochrane systematic review and meta-analysis. Br J Anaesth. 2013 Nov;111(5):711-20. doi: 10.1093/bja/aet213. Epub 2013 Jun 28.
Treede RD, Jensen TS, Campbell JN, Cruccu G, Dostrovsky JO, Griffin JW, Hansson P, Hughes R, Nurmikko T, Serra J. Neuropathic pain: redefinition and a grading system for clinical and research purposes. Neurology. 2008 Apr 29;70(18):1630-5. doi: 10.1212/01.wnl.0000282763.29778.59. Epub 2007 Nov 14.
Fruhstorfer H, Lindblom U, Schmidt WC. Method for quantitative estimation of thermal thresholds in patients. J Neurol Neurosurg Psychiatry. 1976 Nov;39(11):1071-5. doi: 10.1136/jnnp.39.11.1071.
Yarnitsky D, Sprecher E, Zaslansky R, Hemli JA. Heat pain thresholds: normative data and repeatability. Pain. 1995 Mar;60(3):329-32. doi: 10.1016/0304-3959(94)00132-x.
Baumgartner U, Magerl W, Klein T, Hopf HC, Treede RD. Neurogenic hyperalgesia versus painful hypoalgesia: two distinct mechanisms of neuropathic pain. Pain. 2002 Mar;96(1-2):141-51. doi: 10.1016/s0304-3959(01)00438-9.
Magerl W, Wilk SH, Treede RD. Secondary hyperalgesia and perceptual wind-up following intradermal injection of capsaicin in humans. Pain. 1998 Feb;74(2-3):257-68. doi: 10.1016/s0304-3959(97)00177-2.
Price DD, Hu JW, Dubner R, Gracely RH. Peripheral suppression of first pain and central summation of second pain evoked by noxious heat pulses. Pain. 1977 Feb;3(1):57-68. doi: 10.1016/0304-3959(77)90035-5.
Brandsborg B, Dueholm M, Nikolajsen L, Kehlet H, Jensen TS. A prospective study of risk factors for pain persisting 4 months after hysterectomy. Clin J Pain. 2009 May;25(4):263-8. doi: 10.1097/AJP.0b013e31819655ca.
Aasvang EK, Kehlet H. Persistent sensory dysfunction in pain-free herniotomy. Acta Anaesthesiol Scand. 2010 Mar;54(3):291-8. doi: 10.1111/j.1399-6576.2009.02137.x. Epub 2009 Oct 15.
Brandsborg B, Dueholm M, Kehlet H, Jensen TS, Nikolajsen L. Mechanosensitivity before and after hysterectomy: a prospective study on the prediction of acute and chronic postoperative pain. Br J Anaesth. 2011 Dec;107(6):940-7. doi: 10.1093/bja/aer264. Epub 2011 Sep 2.
Gore JL, Litwin MS, Lai J, Yano EM, Madison R, Setodji C, Adams JL, Saigal CS; Urologic Diseases in America Project. Use of radical cystectomy for patients with invasive bladder cancer. J Natl Cancer Inst. 2010 Jun 2;102(11):802-11. doi: 10.1093/jnci/djq121. Epub 2010 Apr 16.
Wallace MS, Wallace AM, Lee J, Dobke MK. Pain after breast surgery: a survey of 282 women. Pain. 1996 Aug;66(2-3):195-205. doi: 10.1016/0304-3959(96)03064-3.
November 2016
Actual (reported)Study Completion
February 2017
Actual (reported)Last Updated
October 4, 2018
Record last verified: 2018-10
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