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.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain
• Intervention / Treatment: Drug: Dilaudid IV Scheduled; Drug: Dilaudid PCA

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45040
      • Good Samaritan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Scheduled IV post op; Patient's will receive scheduled nurse administered IV pain medications post operatively.	Drug: Dilaudid IV Scheduled; Nurse administered IV Dilaudid 0.5mg every 2 hours.; Other Names: hydromorphone
Experimental: PCA post op; Patients will receive PCA for pain control post operatively.	Drug: Dilaudid PCA; PCA setting of 0.3mg demand dose, 8 minute lock out interval, and 5mg 4-hour limit.; Other Names: hydromorphone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Pain Control	Patient's reported pain on a VAS on all postoperative day one.	post operative day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction with Pain Control	Patient's satisfaction with pain control on a VAS on all postoperative day one.	post operative day 1
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
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

Collaborators and Investigators

• Sponsor: TriHealth Inc.
• Investigators: Principal Investigator: Catrina C Crisp, MD, TriHealth Division of Urogynecology

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: September 8, 2010
• First Submitted That Met QC Criteria: September 28, 2011
• First Posted (Estimate): September 29, 2011

Study Record Updates

• Last Update Posted (Estimate): July 10, 2015
• Last Update Submitted That Met QC Criteria: July 9, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: vaginal reconstructive surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Hydromorphone
• Other Study ID Numbers: 10072 (DAIDS ES Registry Number)