Randomized Control Trial to Assess Postoperative Pain After Sling Placement

NCT00746863 | Completed Results

• 1 other identifier: 07-1890
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Keywords

mid-urethral sling; pubovaginal sling; postoperative pain; visual analog scale; suprapubic approach; SPARC sling

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• In-hospital Medication Amounts

  From surgery until discharge, average

• 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.

Study Arms (2)

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.

Drug: 0.125% Marcaine

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.

Interventions

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.

Also known as: 0.125% Bupivacaine

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (10)

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

  PMID: 15377981 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.

  PMID: 2010587 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.

  PMID: 12230614 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.

  PMID: 9258103 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.

  PMID: 11450979 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.

  PMID: 15789144 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.

  PMID: 8798092 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.

  PMID: 14618314 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.

  PMID: 14754707 BACKGROUND

• 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.

  PMID: 21318442 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress; Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and 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.

Results Point of Contact

• Title: Gena Dunivan, MD
• Organization: UNC Hospitals

gdunivan@med.unc.edu

919-966-4717

Study Officials

• Gena C Dunivan, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Ellen C Wells, MD

  UNC Chapel Hill

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 3, 2008
• First Posted: September 4, 2008
• Study Start: January 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: June 22, 2010
• Results First Posted: June 9, 2010

Record last verified: 2010-06

Locations

US (1)