Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery

Not Applicable

Completed

• Conditions: Post Operative Pain
• Interventions: Drug: Dilaudid IV Scheduled; Drug: Dilaudid PCA

• Registration Number: NCT01442818
• Lead Sponsor: TriHealth Inc.

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-08
• Primary Completion: 2011-09
• Study First Submitted QC: 2011-09-28
• Study First Posted: 2011-09-29
• Study Completion: 2012-10
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-09
• Last Update Posted: 2015-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scheduled IV post op	Dilaudid IV Scheduled	Patient's will receive scheduled nurse administered IV pain medications post operatively.
PCA post op	Dilaudid PCA	Patients will receive PCA for pain control post operatively.

Primary Outcome Measures

Name	Time	Method
Patient Pain Control	post operative day 1	Patient's reported pain on a VAS on all postoperative day one.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Good Samaritan Hospital; 🇺🇸 Cincinnati, Ohio, United States