Randomized Control Trial to Assess Postoperative Pain After Sling Placement

Summary

There are many ways to perform a suprapubic approach pubovaginal sling. Some surgeons inject local pain medical into the retropubic space before placing the sling, others do not. This study is to determine if injection of local pain medication into the retropubic space before placing a mid-urethral sling for urinary stress incontinence results in lower postoperative pain scores, lower use of postoperative narcotic medication and lower rates of urinary retention.

Timeline

Start

2007-01

Primary completion

2009-09

Completion

2009-09

Outcome

Mixed primary results

registry MEAN Intervention Group - Received Marcaine: 1.9 (Standard Deviation 2.38) cm NCT00746863 ↗

registry MEAN Control Group - No Marcaine: 2.6 (Standard Deviation 1.78) cm NCT00746863 ↗

registry Intervention Group - Received Marcaine vs Control Group - No Marcaine; p = 0.0251; Wilcoxon (Mann-Whitney) NCT00746863 ↗

registry MEAN Intervention Group - Received Marcaine: 2.1 (Standard Deviation 2.46) cm NCT00746863 ↗

registry Intervention Group - Received Marcaine vs Control Group - No Marcaine; p = 0.258; Wilcoxon (Mann-Whitney) NCT00746863 ↗

registry MEAN Intervention Group - Received Marcaine: 2.0 (Standard Deviation 2.37) cm NCT00746863 ↗

registry Intervention Group - Received Marcaine vs Control Group - No Marcaine; p = 0.435; Wilcoxon (Mann-Whitney) NCT00746863 ↗

Publications

• Background Al-Hayek S, Abrams P. Women's lower urinary tract function and dysfunction: definitions and epidemiology. Minerva Ginecol. 2004 Aug;56(4):311-25.
• Background Hunskaar S, Vinsnes A. The quality of life in women with urinary incontinence as measured by the sickness impact profile. J Am Geriatr Soc. 1991 Apr;39(4):378-82. doi: 10.1111/j.1532-5415.1991.tb02903.x.
• Background van der Vaart CH, de Leeuw JR, Roovers JP, Heintz AP. The effect of urinary incontinence and overactive bladder symptoms on quality of life in young women. BJU Int. 2002 Oct;90(6):544-9. doi: 10.1046/j.1464-410x.2002.02963.x.
• Background Leach GE, Dmochowski RR, Appell RA, Blaivas JG, Hadley HR, Luber KM, Mostwin JL, O'Donnell PD, Roehrborn CG. Female Stress Urinary Incontinence Clinical Guidelines Panel summary report on surgical management of female stress urinary incontinence. The American Urological Association. J Urol. 1997 Sep;158(3 Pt 1):875-80. doi: 10.1097/00005392-199709000-00054.
• Background Nilsson CG, Kuuva N, Falconer C, Rezapour M, Ulmsten U. Long-term results of the tension-free vaginal tape (TVT) procedure for surgical treatment of female stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12 Suppl 2:S5-8. doi: 10.1007/s001920170003.
• Background Richter HE, Norman AM, Burgio KL, Goode PS, Wright KC, Benton J, Varner RE. Tension-free vaginal tape: a prospective subjective and objective outcome analysis. Int Urogynecol J Pelvic Floor Dysfunct. 2005 Mar-Apr;16(2):109-13. doi: 10.1007/s00192-004-1238-5. Epub 2004 Oct 23.
• Background Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1996;7(2):81-5; discussion 85-6. doi: 10.1007/BF01902378.
• Background Schatz H, Henriksson L. Pain during the TVT procedure performed under local anesthesia. Int Urogynecol J Pelvic Floor Dysfunct. 2003 Nov;14(5):347-9; discussion 349. doi: 10.1007/s00192-003-1043-6. Epub 2003 Sep 6.
• Background Dogan E, Celiloglu M, Sarihan E, Demir A. Anesthetic effect of intrauterine lidocaine plus naproxen sodium in endometrial biopsy. Obstet Gynecol. 2004 Feb;103(2):347-51. doi: 10.1097/01.AOG.0000109519.74229.30.
• Dunivan GC, Parnell BA, Connolly A, Jannelli ML, Horton BJ, Geller EJ. Bupivacaine injection during midurethral sling and postoperative pain: a randomized controlled trial. Int Urogynecol J. 2011 Apr;22(4):433-8. doi: 10.1007/s00192-011-1362-y. Epub 2011 Feb 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bupivacaine	Other / unclassified	0.125 %	Other
Subject	Bupivacaine	Other / unclassified	120 ml	Other

Indications