Randomized Control Trial to Assess Postoperative Pain After Sling Placement

This study has been completed.
Sponsor:
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00746863
First received: September 3, 2008
Last updated: June 15, 2010
Last verified: June 2010
  Purpose

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 Intervention
Stress Urinary Incontinence
Drug: 0.125% Marcaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Injection of 0.125% Marcaine During Mid-Urethral Sling Placement for Pain Relief: A Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Difference in Postoperative Pain Using a Visual Analog Scale at 2 Hours. [ Time Frame: 2 hours postoperative from mid-urethral sling placement ] [ Designated as safety issue: No ]
    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".

  • Difference in Postoperative Pain Using a Visual Analog Scale at 6 Hours. [ Time Frame: 6 hours postoperative from mid-urethral sling placement ] [ Designated as safety issue: No ]
    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".

  • Difference in Postoperative Pain Using a Visual Analog Scale at 24 Hours. [ Time Frame: 24 hours postoperative from mid-urethral sling placement ] [ Designated as safety issue: No ]
    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:
  • In-hospital Medication Amounts [ Time Frame: From surgery until discharge, average ] [ Designated as safety issue: No ]
    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.

  • Difference in Successful Voiding Trial Prior to Discharge Following Placement of Mid-urethral Sling Via the Suprapubic Approach. [ Time Frame: From after surgery to discharge from hospital. ] [ Designated as safety issue: No ]
    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.


Enrollment: 42
Study Start Date: January 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746863

Locations
United States, North Carolina
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
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gena Dunivan, Clinical Fellow, UNC Chapel Hill
ClinicalTrials.gov Identifier: NCT00746863     History of Changes
Other Study ID Numbers: 07-1890
Study First Received: September 3, 2008
Results First Received: March 19, 2010
Last Updated: June 15, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
mid-urethral sling
pubovaginal sling
postoperative pain
visual analog scale
suprapubic approach
SPARC sling

Additional relevant MeSH terms:
Pain, Postoperative
Urinary Incontinence
Urinary Incontinence, Stress
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014