Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery

TriHealth Inc.54 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Post Operative Pain

Interventions

Dilaudid PCADRUG

PCA setting of 0.3mg demand dose, 8 minute lock out interval, and 5mg 4-hour limit.

Dilaudid IV ScheduledDRUG

Nurse administered IV Dilaudid 0.5mg every 2 hours.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Good Samaritan Hospital

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Patient Pain Control

Patient's reported pain on a VAS on all postoperative day one.

Time frame: post operative day 1

Secondary Outcomes

Patient Satisfaction with Pain Control

Patient's satisfaction with pain control on a VAS on all postoperative day one.

Time frame: 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.

Time frame: 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.

Time frame: 2 weeks post op

Data from ClinicalTrials.gov

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