Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01442818
• Other study ID #: 10072
• Status: Completed
• Phase: N/A
• First received: September 8, 2010
• Last updated: July 9, 2015
• Start date: September 2010
• Est. completion date: October 2012

Study information

• Verified date: July 2015
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Dilaudid PCA
PCA setting of 0.3mg demand dose, 8 minute lock out interval, and 5mg 4-hour limit.
• Dilaudid IV Scheduled
Nurse administered IV Dilaudid 0.5mg every 2 hours.

Locations

Country	Name	City	State
United States	Good Samaritan Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Pain Control	Patient's reported pain on a VAS on all postoperative day one.	post operative day 1
Secondary	Patient Satisfaction with Pain Control	Patient's satisfaction with pain control on a VAS on all postoperative day one.	post operative day 1
Secondary	patient perceived pain at 2 weeks	VAS for pain will be filled out at the patient's two week post op office visit.	2 weeks post op
Secondary	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.	2 weeks post op