Post Operative Pain
Conditions
Keywords
vaginal reconstructive surgery
Brief summary
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.
Detailed description
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.
Interventions
DRUGDilaudid PCA
PCA setting of 0.3mg demand dose, 8 minute lock out interval, and 5mg 4-hour limit.
DRUGDilaudid IV Scheduled
Nurse administered IV Dilaudid 0.5mg every 2 hours.
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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 exclusion.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Pain Control | post operative day 1 | Patient's reported pain on a VAS on all postoperative day one. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction with Pain Control | post operative day 1 | Patient's satisfaction with pain control on a VAS on all postoperative day one. |
| patient perceived pain at 2 weeks | 2 weeks post op | VAS for pain will be filled out at the patient's two week post op office visit. |
| patient dissatisfaction with pain control at 2 weeks | 2 weeks post op | patient will fill out a VAS for satisfaction with pain control at their two week post operative visit. |
Countries
United States
Outcome results
None listed