Randomized Control Trial to Assess Postoperative Pain After Sling Placement

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Completed
• CT.gov ID: NCT00746863
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 2
• Duration (Months): 32
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Drug: 0.125% Marcaine	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Injection of 0.125% Marcaine During Mid-Urethral Sling Placement for Pain Relief: A Randomized Control Trial
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 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.	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.; Other Names: 0.125% Bupivacaine
No Intervention: 2 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.

Outcome Measures

Primary Outcome Measures

1. Difference in Postoperative Pain Using a Visual Analog Scale at 2 Hours. [2 hours postoperative from mid-urethral sling placement]

   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. Difference in Postoperative Pain Using a Visual Analog Scale at 6 Hours. [6 hours postoperative from mid-urethral sling placement]

   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".

3. Difference in Postoperative Pain Using a Visual Analog Scale at 24 Hours. [24 hours postoperative from mid-urethral sling placement]

   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".

Secondary Outcome Measures

1. In-hospital Medication Amounts [From surgery until discharge, average]

   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.

2. Difference in Successful Voiding Trial Prior to Discharge Following Placement of Mid-urethral Sling Via the Suprapubic Approach. [From after surgery to discharge from hospital.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599

Sponsors and Collaborators

• University of North Carolina, Chapel Hill

Investigators

• Principal Investigator: Gena C Dunivan, MD, University of North Carolina, Chapel Hill
• Study Director: Ellen C Wells, MD, UNC Chapel Hill

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• ClinicalTrials.gov Identifier: NCT00746863
• Other Study ID Numbers: 07-1890
• First Posted: Sep 4, 2008
• Last Update Posted: Jun 22, 2010
• Last Verified: Jun 1, 2010

• Keywords provided by , ,: mid-urethral sling; pubovaginal sling; postoperative pain; visual analog scale; suprapubic approach; SPARC sling
• Additional relevant MeSH terms: Urinary Incontinence; Urinary Incontinence, Stress; Bupivacaine

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Intervention Group - Received Marcaine	Control Group - No Marcaine
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	21	21
COMPLETED	21	21
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Intervention Group - Received Marcaine	Control Group - No Marcaine	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	21	21	42
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	18 85.7%	19 90.5%	37 88.1%
>=65 years	3 14.3%	2 9.5%	5 11.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.4 (13.5)	52.6 (10.7)	52 (12)
Sex: Female, Male (Count of Participants)
Female	21 100%	21 100%	42 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	21 100%	21 100%	42 100%

Outcome Measures

1. Primary Outcome

Title	Difference in Postoperative Pain Using a Visual Analog Scale at 2 Hours.
Description	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".
Time Frame	2 hours postoperative from mid-urethral sling placement

Outcome Measure Data

Analysis Population Description

Analysis was intention to treat. One patient in the intervention did not have a 2 hour VAS collected.

Arm/Group Title	Intervention Group - Received Marcaine	Control Group - No Marcaine
Arm/Group Description	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.	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.
Measure Participants	20	21
Mean (Standard Deviation) [cm]	1.9 (2.38)	2.6 (1.78)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Group - Received Marcaine, Control Group - No Marcaine
	Comments	A 2.0 cm difference on a 10.0 cm VAS scale was clinically significant. Assuming a power of 80% to detect a 2.0 difference on scores between groups, standard deviation of 2.2, an α of 0.05, then, 21 patients would be needed in each group for a total of 42 subjects. A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0251
	Comments	A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	In-hospital Medication Amounts
Description	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.
Time Frame	From surgery until discharge, average

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group - Received Marcaine	Control Group - No Marcaine
Arm/Group Description	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.	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.
Measure Participants	21	21
Mean (Standard Deviation) [number of pills]	4 (3.83)	6 (4.32)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Group - Received Marcaine, Control Group - No Marcaine
	Comments	A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0923
	Comments	Adjusted for multiple comparisions
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

Title	Difference in Successful Voiding Trial Prior to Discharge Following Placement of Mid-urethral Sling Via the Suprapubic Approach.
Description	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.
Time Frame	From after surgery to discharge from hospital.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group - Received Marcaine	Control Group - No Marcaine
Arm/Group Description	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.	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.
Measure Participants	21	21
Number [participants w/sucessful voiding trial]	4 19%	7 33.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Group - Received Marcaine, Control Group - No Marcaine
	Comments	Chi square was performed to compared the two groups and the patient's ability to pass their voiding trial prior to discharge
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4756
	Comments
	Method	Chi-squared
	Comments

4. Primary Outcome

Title	Difference in Postoperative Pain Using a Visual Analog Scale at 6 Hours.
Description	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".
Time Frame	6 hours postoperative from mid-urethral sling placement

Outcome Measure Data

Analysis Population Description

Intention to treat

Arm/Group Title	Intervention Group - Received Marcaine	Control Group - No Marcaine
Arm/Group Description	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.	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.
Measure Participants	21	21
Mean (Standard Deviation) [cm]	2.1 (2.46)	2.3 (2.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Group - Received Marcaine, Control Group - No Marcaine
	Comments	A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups. Normality of continuous variables was assessed using the Shapiro-Wilk test. For categorical data, Fisher's exact test was used to evaluate the data. A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.258
	Comments	A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.
	Method	Wilcoxon (Mann-Whitney)
	Comments

5. Primary Outcome

Title	Difference in Postoperative Pain Using a Visual Analog Scale at 24 Hours.
Description	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".
Time Frame	24 hours postoperative from mid-urethral sling placement

Outcome Measure Data

Analysis Population Description

Analysis was intention to treat. One patient in the control group was discharged before her 24 hour VAS was collected.

Arm/Group Title	Intervention Group - Received Marcaine	Control Group - No Marcaine
Arm/Group Description	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.	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.
Measure Participants	21	20
Mean (Standard Deviation) [cm]	2.0 (2.37)	2.3 (2.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Group - Received Marcaine, Control Group - No Marcaine
	Comments	A t-test was used in comparing the intervention and control groups, if continuous variables were approximately normal. If data were not approximately normal, a Mann-Whitney Wilcoxon test was used in comparing the two groups. Normality of continuous variables was assessed using the Shapiro-Wilk test. For categorical data, Fisher's exact test was used to evaluate the data. A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.435
	Comments	A Bonferroni correction was used when evaluating the VAS results to adjust for multiple comparisons.
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	From time of surgery to 6 weeks after surgery
Adverse Event Reporting Description	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.
Arm/Group Title	Intervention Group - Received Marcaine		Control Group - No Marcaine
Arm/Group Description	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.		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.
All Cause Mortality
	Intervention Group - Received Marcaine		Control Group - No Marcaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Intervention Group - Received Marcaine		Control Group - No Marcaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/21 (0%)
Other (Not Including Serious) Adverse Events
	Intervention Group - Received Marcaine		Control Group - No Marcaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/21 (14.3%)		1/21 (4.8%)
Renal and urinary disorders
Prolonged voiding dysfunction	0/21 (0%)	0	1/21 (4.8%)	1
Surgical and medical procedures
Blood transfusion	1/21 (4.8%)	1	0/21 (0%)	0
Labial hematoma	1/21 (4.8%)	1	0/21 (0%)	0
Hip pain	1/21 (4.8%)	1	0/21 (0%)	0

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.