Back to resultsPatient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery
Primary Purpose
Post Operative Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dilaudid PCA
Dilaudid IV Scheduled
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain focused on measuring vaginal reconstructive surgery
Eligibility Criteria
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.
Sites / Locations
- Good Samaritan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Scheduled IV post op
PCA post op
Arm Description
Patient's will receive scheduled nurse administered IV pain medications post operatively.
Patients will receive PCA for pain control post operatively.
Outcomes
Primary Outcome Measures
Patient Pain Control
Patient's reported pain on a VAS on all postoperative day one.
Secondary Outcome Measures
Patient Satisfaction with Pain Control
Patient's satisfaction with pain control on a VAS on all postoperative day one.
patient perceived pain at 2 weeks
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
patient will fill out a VAS for satisfaction with pain control at their two week post operative visit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01442818
Brief Title
Patient Satisfaction and Pain Control Following Reconstructive Vaginal 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 Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TriHealth Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
vaginal reconstructive surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Scheduled IV post op
Arm Type
Experimental
Arm Description
Patient's will receive scheduled nurse administered IV pain medications post operatively.
Arm Title
PCA post op
Arm Type
Experimental
Arm Description
Patients will receive PCA for pain control post operatively.
Intervention Type
Drug
Intervention Name(s)
Dilaudid PCA
Other Intervention Name(s)
hydromorphone
Intervention Description
PCA setting of 0.3mg demand dose, 8 minute lock out interval, and 5mg 4-hour limit.
Intervention Type
Drug
Intervention Name(s)
Dilaudid IV Scheduled
Other Intervention Name(s)
hydromorphone
Intervention Description
Nurse administered IV Dilaudid 0.5mg every 2 hours.
Primary Outcome Measure Information:
Title
Patient Pain Control
Description
Patient's reported pain on a VAS on all postoperative day one.
Time Frame
post operative day 1
Secondary Outcome Measure Information:
Title
Patient Satisfaction with Pain Control
Description
Patient's satisfaction with pain control on a VAS on all postoperative day one.
Time Frame
post operative day 1
Title
patient perceived pain at 2 weeks
Description
VAS for pain will be filled out at the patient's two week post op office visit.
Time Frame
2 weeks post op
Title
patient dissatisfaction with pain control at 2 weeks
Description
patient will fill out a VAS for satisfaction with pain control at their two week post operative visit.
Time Frame
2 weeks post op
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catrina C Crisp, MD
Organizational Affiliation
TriHealth Division of Urogynecology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Good Samaritan Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery
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