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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Patients randomized to this 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. |
|
| 2 | No Intervention | Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.125% Marcaine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Difference in Successful Voiding Trial Prior to Discharge Following Placement of Mid-urethral Sling Via the Suprapubic Approach. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gena C Dunivan, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Ellen C Wells, MD | UNC Chapel Hill | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15377981 | 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. | |
| 2010587 | 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. |
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From January 2008 to September of 2009, all female patients planning to undergo a sling with or without an anterior or posterior repair at the University of North Carolina (UNC) Hospital were approached for participation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group - Received Marcaine | Patients randomized to this 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. |
| FG001 | Control Group - No Marcaine | Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group - Received Marcaine | Patients randomized to this 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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". | Analysis was intention to treat. One patient in the intervention did not have a 2 hour VAS collected. | Posted | Mar 2010 | Mean | Standard Deviation | cm | 2 hours postoperative from mid-urethral sling placement |
|
From time of surgery to 6 weeks after surgery
A total of 4 adverse events were documented, 3 in the intervention group and one in the control group. These included right hip pain, a right labial hematoma, a patient with prolonged urinary retention requiring sling release and one blood transfusion. However, these were felt to be related to the surgery itself.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group - Received Marcaine | Patients randomized to this 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood transfusion | Surgical and medical procedures | Systematic Assessment | One patient in the Intervention group - Marcaine, required a blood transfusion postoperatively secondary to low starting hematocrit preoperatively. |
Our exclusion criteria were strict, and as such, results presented here may have limited generalizability. Other limitations include that we can only address operations performed under general anesthesia.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gena Dunivan, MD | UNC Hospitals | 919-966-4717 | gdunivan@med.unc.edu |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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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. |
| 12230614 | 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. |
| 9258103 | 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. |
| 11450979 | 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. |
| 15789144 | 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. |
| 8798092 | 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. |
| 14618314 | 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. |
| 14754707 | 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. |
| 21318442 | Derived | 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. |
| BG001 |
| Control Group - No Marcaine |
Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Only female patients | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control Group - No Marcaine | Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space. |
|
|
|
| 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. | Posted | Mar 2010 | Mean | Standard Deviation | number of pills | From surgery until discharge, average |
|
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|
| 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. | Posted | Mar 2010 | Number | participants w/sucessful voiding trial | From after surgery to discharge from hospital. |
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| 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". | Intention to treat | Posted | Mar 2010 | Mean | Standard Deviation | cm | 6 hours postoperative from mid-urethral sling placement |
|
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| 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". | Analysis was intention to treat. One patient in the control group was discharged before her 24 hour VAS was collected. | Posted | Mar 2010 | Mean | Standard Deviation | cm | 24 hours postoperative from mid-urethral sling placement |
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|
| 0 |
| 21 |
| 3 |
| 21 |
| EG001 | Control Group - No Marcaine | Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space. | 0 | 21 | 1 | 21 |
|
| Labial hematoma | Surgical and medical procedures | Systematic Assessment | One patient in the Intervention group - Marcaine, had a labial hematoma noted postoperatively, this self-limited and resolved spontaneously |
|
| Hip pain | Surgical and medical procedures | Systematic Assessment | One patient in the Intervention group - Marcaine, complained of right hip pain on postoperative day 1. This resolved with conservative measures. |
|
| Prolonged voiding dysfunction | Renal and urinary disorders | Systematic Assessment | One patient in the Control group - No marcaine, had prolonged incomplete emptying and had a release of her sling 6 weeks after her initial surgery. |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D000588 |
| Amines |