Status:
UNKNOWN
Surgical Site Infiltration of Exparel vs TAP Block With Exparel in Patients Undergoing Laparotomy Via Midline Incision
Lead Sponsor:
Danbury Hospital
Conditions:
Postoperative Pain
Postoperative Nausea and Vomiting
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
This is a randomized-controlled prospective study to be conducted at Danbury Hospital and Norwalk Hospital to compare postoperative opioid consumption and pain scores of patients with suspected or kno...
Detailed Description
Recent studies suggest surgical site infiltration of local anesthetic into the preperitoneal, subfascial and/or subcutaneous planes as an alternative approach. The literature suggests this offers supe...
Eligibility Criteria
Inclusion
- Any woman age 18 or over with known or suspected gynecologic malignancy who is scheduled for laparotomy via vertical midline incision at Danbury Hospital or Norwalk Hospital
- American Society of Anesthesiologists physical status I to IV (a normal healthy patient to a patient with severe systemic disease that may be constant threat to life)
- English or Spanish speaking
Exclusion
- Pregnancy
- Unable to obtain consent
- Severe allergies and/or anaphylaxis to bupivacaine or other anesthetics of the same class, to hydromorphone or morphine equivalents
- Patients taking fospropofol, hyaluronidase, propofol, propranolol, St John's Wort and verapamil at the time of screening
- Significant psychiatric disturbance as recorded in the medical record
- Current or history of alcohol or drug addiction
- Have current acute or chronic pain disorders as indicated in medical record
- Current or history of opioid dependence
- Contraindications to acetaminophen (significant hepatic dysfunction or disease), ketorolac and ibuprofen (significant renal dysfunction or reactive airway disease)
- ≥2 previous midline laparotomies
- BMI \>45
Key Trial Info
Start Date :
July 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT03870685
Start Date
July 5 2018
End Date
December 31 2021
Last Update
July 14 2021
Active Locations (1)
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1
Danbury Hospital
Danbury, Connecticut, United States, 06810