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



Status:Completed
Conditions:Post-Surgical Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:19 - Any
Updated:6/8/2018
Start Date:April 2016
End Date:May 2018

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

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.

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.

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
We found this trial at
2
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Morristown, New Jersey 07960
Phone: 973-971-7361
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Summit, New Jersey 07901
Phone: 973-971-7361
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Summit, NJ
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