Randomized Trial of Wound Infiltration With Extended-release Bupivacaine Before Laparoscopic or Robotic Hysterectomy

Completed · Phase 4

Conditions studied: Pain, Postoperative, Surgical Procedure, Unspecified

In brief

The investigators are studying ways to improve pain control after surgery. One way to decrease pain is to inject incisions with a numbing medicine (local anesthetic) while in the operating room. There is an FDA approved extended-release version of a commonly used local anesthetic (bupivacaine) that can last for 4 days instead of 6 hours. The investigators are studying whether using the extended-release medication (Exparel) will give better pain relief after laparoscopic and robotic-assisted hysterectomies.

Key facts

Study ID

NCT02352922

Run by

AdventHealth

People needed

64

Starts

2015-07-01

Expected to finish

2016-02-01

Last updated by the study team

2020-10-01

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Benign indication for surgery
• Planned multiport laparoscopic or robotic assisted hysterectomy
• Non-pregnant
• Able to provide informed consent
• Owns smartphone or computer with internet access
• Willing to provide contact phone number and accept SMS text messages
• Ability to speak and read English (because texts and online surveys will be in English only)

You may not qualify if…

• Planned additional procedures (e.g. incontinence surgery, prolapse repair or bowel surgery)
• Contraindication to study drug
• Severe Hepatic disease
• Severe Kidney disease
• Current use of monoamine oxidase inhibitors
• Current use of tricyclic antidepressants
• History of substance or alcohol abuse within the past 2 years

Where it is running

• Florida Hospital Orlando — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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