Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery

Condition(s) targeted: Post Operative Pain

Intervention: Dilaudid PCA (Drug); Dilaudid IV Scheduled (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: TriHealth Inc.

Official(s) and/or principal investigator(s):
Catrina C Crisp, MD, Principal Investigator, Affiliation: TriHealth Division of Urogynecology

Overall contact:
Catrina C Crisp Harmon, MD, Phone: 513-862-4171, Email: catrina_crisp@trihealth.com

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.

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Patient Pain Control

Secondary outcome:

Patient Satisfaction with Pain Control

patient perceived pain at 2 weeks

patient dissatisfaction with pain control at 2 weeks

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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Female.

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.

Catrina C Crisp Harmon, MD, Phone: 513-862-4171, Email: catrina_crisp@trihealth.com

Good Samaritan Hospital, Cincinnati, Ohio 45040, United States; Recruiting
Catrina C Crisp, MD, Principal Investigator

Starting date: September 2010
Last updated: September 28, 2011