Randomized Control Trial to Assess Postoperative Pain After Sling Placement

Stress Urinary Incontinence Clinical Trial

Official title:

Injection of 0.125% Marcaine During Mid-Urethral Sling Placement for Pain Relief: A Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746863
• Other study ID #: 07-1890
• Status: Completed
• Phase: N/A
• First received: September 3, 2008
• Last updated: June 15, 2010
• Start date: January 2007
• Est. completion date: September 2009

Study information

• Verified date: June 2010
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

To evaluate if an injection in the retropubic space with a local acting anesthetic, Marcaine, (bupivacaine) at the time of mid-urethral sling placement will improve patients' reported post operative pain and decrease the use of narcotic pain medication. This study will include all female patients age 18 and older who will undergo a mid-urethral sling with or without anterior repair for the treatment of urinary stress incontinence by a member of the Division of Urogynecology and Reconstructive Pelvic Surgery who consent to be in the study.

Once patients have consented to participate in the study they will be randomized into two groups. One group will have the mid-urethral sling placed in the usual fashion with no injection of local anesthetic. The other group will have the mid-urethral sling placed after the retropubic space has been infiltrated with local anesthetic as previously described in the literature. Pain will be assessed with the use of a Visual Analog Scale during the hospitalization and the use of narcotic pain medication will be assessed during recovery and overnight in the hospital. Patients will be asked to record how often and what type of pain medication they use. Patients will also be asked to keep a log of their urination if they are discharged home with self catheterization. They will be asked to mail in their pain medication log and voiding diary (if needed) at a two-week post-operative. Outcomes will then be compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any female patient, age 18 or older, who elects to have a mid-urethral sling with or without an anterior or posterior repair at the University of North Carolina Hospitals by a member of the Division of Urogynecology.

Exclusion Criteria:

• Any patient with a chronic pain syndrome, a contraindication to nonsteroidal anti-inflammatory drugs (NSAIDs) such as liver disease, abnormal coagulation, esophageal disorders or peptic ulcers or where pain evaluation is unreliable because of neurological disease and those on treatment with steroids/NSAIDs/opioids prior to surgery.

• Also excluded will be any patient who is having any other reconstructive pelvic surgery concomitantly or would require the placement of a suprapubic catheter.

• Patients electing to have their surgery with regional anesthesia, such as an epidural or spinal will be excluded.

• All minors, decisional impaired people, nursing mothers and non-English speaking people will be excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Drug:
• 0.125% Marcaine
Patients randomized to the intervention arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

References & Publications (9)

Al-Hayek S, Abrams P. Women's lower urinary tract function and dysfunction: definitions and epidemiology. Minerva Ginecol. 2004 Aug;56(4):311-25. Review. — View Citation

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. — View Citation

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. Erratum in: J Am Geriatr Soc 1992 Sep;40(9):976-7. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2004 Oct 23. — View Citation

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. Epub 2003 Sep 6. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Postoperative Pain Using a Visual Analog Scale at 2 Hours.	At approximately two hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented "no pain" and 10 represented the" worst pain ever".	2 hours postoperative from mid-urethral sling placement	No
Primary	Difference in Postoperative Pain Using a Visual Analog Scale at 6 Hours.	At approximately six hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented "no pain" and 10 represented the" worst pain ever".	6 hours postoperative from mid-urethral sling placement	No
Primary	Difference in Postoperative Pain Using a Visual Analog Scale at 24 Hours.	At approximately twenty-four hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented "no pain" and 10 represented the" worst pain ever".	24 hours postoperative from mid-urethral sling placement	No
Secondary	In-hospital Medication Amounts	Secondary outcome included differences in amount of pain medication used in the hospital. This was assessed by comparing the number of pills of oral narcotics the patient took while hospitalized.	From surgery until discharge, average	No
Secondary	Difference in Successful Voiding Trial Prior to Discharge Following Placement of Mid-urethral Sling Via the Suprapubic Approach.	Prior to discharge, patients underwent voiding trials. At our institution, in order to pass the voiding trial, they must void at least 200 cc spontaneously and have less than 100 cc as a post void residual two times in a row.	From after surgery to discharge from hospital.	No