Postoperative Pain Clinical Trial
Official title:
Extended Release Local Anesthetic for Postsurgical Pain After Posterior Colporrhaphy and Perineorrhaphy: A Randomized Controlled Study
Verified date | May 2020 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The specific aim of this randomized double-blind clinical trial is to evaluate the effect of intraoperative infiltration of liposomal bupivacaine at the time of posterior colporrhaphy and/or perineorrhaphy on postsurgical pain scores during the first 72 hours after surgery as measured by visual analog scales (VAS) for patients undergoing surgery for pelvic organ prolapse. Study subjects are randomized to 30 mL of liposomal bupivacaine versus 30 mL of injectable normal saline administered in a standardized technique into the posterior vaginal compartment at the time of posterior repair and/or perineorrhaphy.
Status | Completed |
Enrollment | 72 |
Est. completion date | March 31, 2019 |
Est. primary completion date | March 12, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - English-speaking women ages 18 and older undergoing posterior repair and/or perineorrhaphy at our institution for pelvic organ prolapse Exclusion Criteria: - Planned regional anesthesia - Allergy or contraindication to bupivacaine - Allergy or contraindication to opioids - Allergy or contraindication to non-steroidal medications - Planned laparotomy - Chronic pain diagnosis and/or chronic narcotic use |
Country | Name | City | State |
---|---|---|---|
United States | Women's Center for Pelvic Health | Charlotte | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative Pain | As measured by a 100 mm Visual Analog Scale (VAS). This scale ranges from 0-100 mm with 0 mm indicating no pain and 100 mm indicating the most pain. The study is powered to detect a decrease in postoperative pain by 20 mm on this scale, which is considered to be a clinically meaningful difference in prior studies. Results will be reported as mean pain scores at each time point (night of surgery, morning and evening for the first 72 hours after surgery, i.e. until postoperative day#3). | Night of surgery (POD#0), POD#1 morning, POD#1 evening, POD#2 morning, POD#2 evening, POD#3 morning, POD#3 evening | |
Secondary | Number of Participants Reporting Satisfaction With Pain Control | As measured by a 5-question satisfaction survey administered at a 2 week postoperative visit. The survey includes Likert scale responses ranging from very unsatisfied to very satisfied with the surgical experience and specifically analgesia. "Patient Satisfaction" was defined as response "satisfied" or "very satisfied" on the Likert Scale. Average responses will be reported. | 2 weeks after surgery | |
Secondary | Time to First Opioid Administration | Median time until first opioid administered after surgery | Assessed up to 72 hours after surgery | |
Secondary | Total Opioid Administration | Measured in milligram morphine equivalents | Cumulatively, over a time period of 72 hours after surgery | |
Secondary | Number of Antiemetic Doses Required Per Participant While Inpatient | Number of as-needed antiemetic doses patient received while in the hospital after surgery | Cumulatively, over a time period of 72 hours after surgery | |
Secondary | Hospital Length of Stay | Total length of hospital stay measured in hours, including readmissions | Assessed until 30 days after surgery | |
Secondary | Length of Stay in Post-anesthesia Care Unit (PACU) | Total length of stay in PACU measured in minutes | Assessed up to 72 hours after surgery | |
Secondary | Number of Participants Who Had a Bowel Movement Within the First 3 Postoperative Days | As recorded by patient - patients were asked each postoperative day (i.e. POD#0, POD#1, POD#2, POD#3) if they had a bowel movement that day, yes or no. | 72 hours after surgery | |
Secondary | Voiding Trial Failures | Proportion of patients discharged home with Foley catheters after failed voiding trials in the hospital | 2 weeks after surgery | |
Secondary | Number of Patients With Adverse Events | Total adverse postoperative events | Assessed until 30 days after surgery |
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