Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery

NCT01442818 | Completed DMC

• 1 other identifier: 10072
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Keywords

vaginal reconstructive surgery

Outcome Measures

Primary Outcomes (1)

• Patient Pain Control

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

  post operative day 1

Secondary Outcomes (3)

• Patient Satisfaction with Pain Control

  post operative day 1

• patient perceived pain at 2 weeks

  2 weeks post op

• patient dissatisfaction with pain control at 2 weeks

  2 weeks post op

Study Arms (2)

Scheduled IV post op

EXPERIMENTAL

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

Drug: Dilaudid IV Scheduled

PCA post op

EXPERIMENTAL

Patients will receive PCA for pain control post operatively.

Drug: Dilaudid PCA

Interventions

Dilaudid PCA DRUG

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

Also known as: hydromorphone

PCA post op

Dilaudid IV Scheduled DRUG

Nurse administered IV Dilaudid 0.5mg every 2 hours.

Also known as: hydromorphone

Scheduled IV post op

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

Good Samaritan Hospital

Cincinnati, Ohio, 45040, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Hydromorphone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Catrina C Crisp, MD

  TriHealth Division of Urogynecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2010
• First Posted: September 29, 2011
• Study Start: September 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2012
• Last Updated: July 10, 2015

Record last verified: 2015-07

Locations

US (1)