Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery

TriHealth

Status: Completed

Conditions: Post Operative Pain

Treatments: Drug: Dilaudid PCA; Drug: Dilaudid IV Scheduled

Study type: Interventional

Funder types: Other

Identifiers

NCT01442818

10072 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

54 participants in 2 patient groups

Scheduled IV post op

Experimental group

Description:

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

Treatment:

Drug: Dilaudid IV Scheduled

PCA post op

Experimental group

Description:

Patients will receive PCA for pain control post operatively.

Treatment:

Drug: Dilaudid PCA