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Completed

NCT Number: NCT02875015

Liposomal Bupivacaine vs. Bupivacaine Hydrochloride and Lidocaine During Suburethral Sling Placement

Postoperative pain, the quality of their recovery and the opioid consumption following a midurethral sling placement are being compared between 2 groups. One group will have the hydro-dissection performed with a diluted liposomal bupivacaine solution. The other group will have the hydro-dissection performed with a diluted bupivacaine HCL and Lidocaine solution.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Morrristown Medical Center, Morristown, New Jersey, United States

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About this study

This is a prospective, comparative, randomized study. Women with pure stress urinary incontinence or mixed urinary incontinence with a predominant stress component who had chosen to proceed with a midurethral sling will be randomized to two groups. The study group will have the hydro-dissection performed with a diluted liposomal bupivacaine solution. The comparison group would have the hydro-dissection performed with a diluted bupivacaine HCL and Lidocaine solution. The postoperative pain will be compared between groups using a visual analog scale. The quality of recovery will be compared between the groups using the quality of recovery short form. Postoperative opioid consumption will be compared between the two groups.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA physical status I-III
  • Age >18 years
  • Not Pregnant
  • Able to give informed consent
  • Electively chose surgical management of SUI with a suburethral sling

Exclusion criteria

  • Pregnant or nursing
  • Allergy to amide anesthetics
  • History of drug or alcohol abuse
  • Severe cardiovascular, hepatic, renal disease or neurological impairment,
  • Long-acting opioid within 3 days or any opioid use within 24 hours before surgery
  • Patients taking monoamineoxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types
  • Contraindication to: Acetaminophen, Non-steroidal anti-inflammatory drugs (NSAID), Hydrocodone, Oxycodone, Hydromorphone AND Morphine,
  • Administration of an investigational drug within 30 days before this study
  • Chronic pain syndromes
  • Daily NSAID or opioid use
  • Patients undergoing concomitant procedures

Treatment and study plan

Liposomal bupivacaine

Drug

20 mL of Liposomal Bupivacaine (EXPAREL) will be diluted in 80 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars

Other names: EXPAREL

Bupivacaine Hydrochloride and Lidocaine

Drug

Bupivacaine Hydrochloride (HCL) and Lidocaine. Fifty mL of 0.05% Marcaine and 30 mL of Lidocaine will be diluted in 100 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars during the placement of a suburethral sling.

Other names: Marcaine and Lidocaine

Suburethral Sling

Procedure

A retropubic, transobturator or mini-sling will be placed in the usual fashion followed by diagnostic cystoscopy.

Other names: Midurethral Sling

Primary outcomes

  1. Postoperative Day 1 Pain

    Time frame: Patient will record her average pain on postop day 1. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.

    Average pain rating experienced on postoperative day one using the visual analog scale (VAS) on scale of 0 to 10 cm. This will be recorded by the patient prior to going to bed.

Secondary outcomes

  1. Second Stage PACU Postoperative Pain

    Time frame: The PACU nurse will record the patient's pain level upon admission to second stage PACU. These results will be examined and compared at the completion of the study.

    Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced upon admission to second stage PACU.

  2. Postoperative Pain Upon Discharge

    Time frame: The PACU nurse will record the patient's pain level upon discharge to home. These results will be examined and compared at the completion of the study.

    Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced upon discharge from the hospital.

  3. Postoperative Pain Four Hours After Discharge

    Time frame: Record the average pain 4 hours after discharge to home. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.

    Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced. This will be recorded 4 hours after being discharged from the hospital.

  4. Night of Surgery Postoperative Pain

    Time frame: Pt will record her average pain on the night of surgery. She will return this result at her postop visit which is approximately 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.

    Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced that day and recorded prior to going to bed on the night of surgery.

  5. Postoperative Days 2 through 7 Pain

    Time frame: Pt will record her average pain from postop days 2-7. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.

    Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced that day and recorded prior to going to bed on postop days 2-7.

  6. Preoperative Quality of Recovery

    Time frame: The patient will complete the questionnaire prior to surgery. This will be collected prior to surgery. These results will be examined and compared at the completion of the study.

    Baseline Quality of Life and Recovery as measured by the ambulatory QoR15 preoperatively on the day of surgery.

  7. Postoperative Days 1, 7 and 14 Quality of Recovery

    Time frame: The patient will complete the questionnaire on postop days 1, 7 & 14. She will return these results at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.

    Quality of Life and Recovery as measured by the ambulatory QoR15 on postoperative days 1, 7 and 14.

  8. Postoperative Narcotic Consumption

    Time frame: The patient will record narcotic consumption each day from the day of surgery to postop day 7. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.

    The total amount of narcotic taken the night of surgery and each day thereafter through postoperative day seven will be recorded each night prior to going to bed.

Sponsors and collaborators

Lead sponsor

Atlantic Health System

Other

Registry information

Official study title

Liposomal Bupivacaine vs. Bupivacaine Hydrochloride and Lidocaine During Suburethral Sling Placement: a Randomized Control Trial

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 23, 2016
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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