A Prospective Study of Port Site Pain Following Percutaneous Externally-Assembled Laparoscopic Donor Nephrectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Laparoscopic Donor Nephrectomy
- Sponsor
- Loma Linda University
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Time to First Opioid Use
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
A single-arm prospective internally-controlled study. Patients will undergo Percutaneous Externally-Assembled Laparoscopic (PEAL) donor nephrectomy where one or more 3 mm instruments are added or substituted for conventional 5 or 12 mm trocars. Multiple outcome measures (endpoints) will be measured including time to first opioid use, total inpatient opioid dosage, patient ranking of painfulness of each port site, duration of ileus, time to ambulation, length of hospital stay, presence of any intraoperative or postoperative complications, operating time, estimated blood loss, and other routine parameters collected in a prospective surgical study
Detailed Description
Purpose: Prior investigators have created methods to perform laparoscopic surgeries using smaller instruments and ports in an attempt to improve cosmesis and postoperative pain. However, These methods may be limited by the requirement for smaller instruments with decreased functionality or by the loss of instrument triangulation. We have previously published a study regarding the use of a new surgical paradigm (percutaneous externally assembled laparoscopy, or PEAL) in porcine and cadaveric models in order to allow laparoscopic surgery to take place with improved cosmesis and decreased pain while still allowing the use of larger instruments and maintaining instrument triangulation. We now seek to study the use of these instruments in the human patients undergoing laparoscopic urologic surgery. The procedures include: Hundred subjects will be recruited for the study with an expected attrition rate of 10%. Sample size has been minimized, but is necessary for statistical power and conclusions. Subjects will be male and female 18 years or older, of all ethnicities, denominations or other social/economical variations. All participants will speak English fluently in order for consent to be performed properly. Baseline pain score will be calculated through a questionnaire in at the urology clinic. This is a single-arm prospective internally-controlled study. Patients will undergo percutaneous externally-assembled laparoscopic urologic surgery where one or more 3 mm instruments are added or substituted for conventional 5 or 12 mm trocars. Multiple outcome measures (endpoints) will be measured including time to first opioid use, total inpatient opioid dosage, patient ranking of painfulness of each port site, duration of ileus, time to ambulation, length of hospital stay, presence of any intraoperative or postoperative complications, operating time, estimated blood loss, and other routine parameters collected in a prospective surgical study.
Investigators
D. Duane Baldwin
Professor
Loma Linda University
Eligibility Criteria
Inclusion Criteria
- •Patients undergoing laparoscopic donor nephrectomy
Exclusion Criteria
- •Patients unwilling to participate in the study
- •Patients unfit for laparoscopic surgery
Outcomes
Primary Outcomes
Time to First Opioid Use
Time Frame: up to 1 day postoperatively
Measurement of time from leaving the post-anesthesia care unit after surgery until the time of first opioid dispersal, regardless of opioid type.
Total Inpatient Opioid Dosage
Time Frame: 3 days postoperatively
Total opioid dosage administered throughout the patient's inpatient stay. Measured in units of Morphine Milligram Equivalents (MME).
Pain Score of All Surgical Sites
Time Frame: up to 2 days postoperatively
A patient-reported pain score (on a scale of 1-10, with 10 being the worst) for each of the four port-site incisions, as measured by the Brief Pain Inventory. Scores were measured on both post-operative day one and on post-operative day two. The four port-site incisions which patients ranked pain scores for were: #1 - Hand-assist Port; #2 - 12 mm Port; #3 - 5 mm Port; #4 - Percutaneous Externally-Assembled Laparoscopic (PEAL) Port. A mean pain score was calculated by averaging the data across the two days.
Secondary Outcomes
- Estimated Intraoperative Blood Loss(Intraoperatively (up to 6 hours))
- Length of Operative Time(Intraoperatively (up to 6 hours))
- Post-operative Ileus(up to 3 days post-operatively)
- Time to Ambulation(3 days post-operatively)
- Length of Hospital Stay(up do 4 days post-operatively)
- Presence of Intraoperative Complications(Intraoperatively)