Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery

This study is currently recruiting participants.
Verified September 2011 by TriHealth Inc.
Sponsor:
Information provided by (Responsible Party):
Catrina C. Crisp Harmon, TriHealth Inc.
ClinicalTrials.gov Identifier:
NCT01442818
First received: September 8, 2010
Last updated: September 28, 2011
Last verified: September 2011

September 8, 2010
September 28, 2011
September 2010
September 2011   (final data collection date for primary outcome measure)
Patient Pain Control [ Time Frame: post operative day 1 ] [ Designated as safety issue: No ]
Patient's reported pain on a VAS on all postoperative day one.
Same as current
Complete list of historical versions of study NCT01442818 on ClinicalTrials.gov Archive Site
  • Patient Satisfaction with Pain Control [ Time Frame: post operative day 1 ] [ Designated as safety issue: No ]
    Patient's satisfaction with pain control on a VAS on all postoperative day one.
  • patient perceived pain at 2 weeks [ Time Frame: 2 weeks post op ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks post op ] [ Designated as safety issue: No ]
    patient will fill out a VAS for satisfaction with pain control at their two week post operative visit.
Same as current
 
 
 
Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery
Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery: A Randomized Trial Comparing Patient-Controlled Intravenous Analgesia (PCA) to Scheduled Intravenous Analgesia

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.

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.

Interventional
 
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Post Operative Pain
  • Drug: Dilaudid PCA
    PCA setting of 0.3mg demand dose, 8 minute lock out interval, and 5mg 4-hour limit.
    Other Name: hydromorphone
  • Drug: Dilaudid IV Scheduled
    Nurse administered IV Dilaudid 0.5mg every 2 hours.
    Other Name: hydromorphone
  • Experimental: Scheduled IV post op
    Patient's will receive scheduled nurse administered IV pain medications post operatively.
    Intervention: Drug: Dilaudid IV Scheduled
  • Experimental: PCA post op
    Patients will receive PCA for pain control post operatively.
    Intervention: Drug: Dilaudid PCA
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
54
October 2012
September 2011   (final data collection date for primary outcome measure)

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.
Female
18 Years to 70 Years
No
Contact: Catrina C Crisp Harmon, MD 513-862-4171 catrina_crisp@trihealth.com
Contact: Rachel N Pauls, MD 513-862-4171
United States
 
NCT01442818
10072
Yes
Catrina C. Crisp Harmon, TriHealth Inc.
TriHealth Inc.
 
Principal Investigator: Catrina C Crisp, MD TriHealth Division of Urogynecology
TriHealth Inc.
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP