Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery
Information source: TriHealth Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post Operative Pain
Intervention: Dilaudid PCA (Drug); Dilaudid IV Scheduled (Drug)
Sponsored by: TriHealth Inc.
Official(s) and/or principal investigator(s):
Catrina C Crisp, MD, Principal Investigator, Affiliation: TriHealth Division of Urogynecology
The investigators hypothesize that patient controlled analgesia (PCA) provides superior pain
relief and patient satisfaction when compared to scheduled intravenous analgesia following
vaginal reconstructive surgery.
Official title: Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery: A Randomized Trial Comparing Patient-Controlled Intravenous Analgesia (PCA) to Scheduled Intravenous Analgesia
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Patient Pain Control
Patient Satisfaction with Pain Control
patient perceived pain at 2 weeks
patient dissatisfaction with pain control at 2 weeks
The investigators hypothesize that patient controlled analgesia (PCA) provides superior
pain relief and patient satisfaction when compared to scheduled intravenous analgesia
following vaginal reconstructive surgery.
In order to determine if there is a significant correlation, secondary outcomes will include
the daily and total narcotic volume used, common side effects from the opioid including
nausea, vomiting, or pruritis, length of hospital stay, timing of flatus and first bowel
movement, all complications, and procedure performed.
Minimum age: 18 Years.
Maximum age: 70 Years.
- The patients will be limited to those from the Division of Urogynecology to ensure
similar surgical techniques. They will be between the ages of 18 and 70 and
undergoing major vaginal reconstruction.
- All patients must undergo vaginal reconstructive surgery including: anterior repair,
posterior repair, and intraperitoneal vaginal vault suspension. The addition of
vaginal hysterectomy, enterocele repair, or suburethral sling is not cause for
- Any patient who has an allergy to hydromorphone/Dilaudid.
- Any patient already taking chronic opioids, defined as daily use.
- All patients with renal insufficiency or failure.
- All patients with liver failure.
- Any patient who is not having general anesthesia.
- Any patient undergoing abdominal or laparoscopic procedures: sacral colpopexy,
laparoscopic hysterectomy or oophorectomy, Burch procedure, or any procedure that
enters the abdominal fascia.
Locations and Contacts
Good Samaritan Hospital, Cincinnati, Ohio 45040, United States
Starting date: September 2010
Last updated: July 9, 2015