Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery: A Randomized Trial Comparing Patient-Controlled Intravenous Analgesia (PCA) to Scheduled Intravenous Analgesia

Conditions
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Post Operative Pain

Intervention / Treatment
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* Drug: Dilaudid PCA
* Drug: Dilaudid IV Scheduled


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scheduled IV post op<br>Patient's will receive scheduled nurse administered IV pain medications post operatively. | Drug: Dilaudid IV Scheduled<br>* Nurse administered IV Dilaudid 0.5mg every 2 hours.<br>* Other names: hydromorphone;|
| Experimental: PCA post op<br>Patients will receive PCA for pain control post operatively. | Drug: Dilaudid PCA<br>* PCA setting of 0.3mg demand dose, 8 minute lock out interval, and 5mg 4-hour limit.<br>* Other names: hydromorphone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Pain Control | Patient's reported pain on a VAS on all postoperative day one. | post operative day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction with Pain Control | Patient's satisfaction with pain control on a VAS on all postoperative day one. | post operative day 1 | 
| patient perceived pain at 2 weeks | VAS for pain will be filled out at the patient's two week post op office visit. | 2 weeks post op | 
| 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. | 2 weeks post op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaginal reconstructive surgery