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OpenTrials
Completed

NCT Number: NCT01442818

Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Good Samaritan Hospital

Cincinnati, Ohio, 45040, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dilaudid PCA

Drug

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

Other names: hydromorphone

Dilaudid IV Scheduled

Drug

Nurse administered IV Dilaudid 0.5mg every 2 hours.

Other names: hydromorphone

Primary outcomes

  1. Patient Pain Control

    Time frame: post operative day 1

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

Secondary outcomes

  1. Patient Satisfaction with Pain Control

    Time frame: post operative day 1

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

  2. patient perceived pain at 2 weeks

    Time frame: 2 weeks post op

    VAS for pain will be filled out at the patient's two week post op office visit.

  3. patient dissatisfaction with pain control at 2 weeks

    Time frame: 2 weeks post op

    patient will fill out a VAS for satisfaction with pain control at their two week post operative visit.

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Sep 29, 2011
Registry last updated
Jul 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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