Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery

NCT ID: NCT01442818

Last Updated: 2015-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-10-31

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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Scheduled IV post op

Patient's will receive scheduled nurse administered IV pain medications post operatively.

Group Type: EXPERIMENTAL

Dilaudid IV Scheduled

Intervention Type: DRUG

Nurse administered IV Dilaudid 0.5mg every 2 hours.

PCA post op

Patients will receive PCA for pain control post operatively.

Group Type: EXPERIMENTAL

Dilaudid PCA

Intervention Type: DRUG

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

Interventions

Dilaudid PCA

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

Intervention Type: DRUG

Dilaudid IV Scheduled

Nurse administered IV Dilaudid 0.5mg every 2 hours.

Intervention Type: DRUG

Other Intervention Names

hydromorphone; hydromorphone

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

TriHealth Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catrina C Crisp, MD

Role: PRINCIPAL_INVESTIGATOR

TriHealth Division of Urogynecology

Locations

Good Samaritan Hospital

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

10072

Identifier Type: -

Identifier Source: org_study_id