Pain
Conditions
Brief summary
The purpose of this study is to determine if there is a difference in pain perception by participants when the assistant port size varies by 50% (8 mm to 12 mm).
Detailed description
Minimally invasive approaches trade a single longer incision for 4-5 smaller incisions that allow abdominal access and abdominal insufflation through ports. The increase in operative times is mostly due to the need to pass suture, needles, cameras and instruments through the abdominal ports. While, it is intuitive that smaller abdominal ports will result in less pain at the incision site, the port size is also limited by instrument size and the size of the needle. When ports are smaller, it can take a little more time for a needle or instrument to be passed into the port. There is a paucity of research comparing different port sizes as they relate to participate pain and operative time especially in a randomized controlled trial setting. The investigators goal would be to determine if there is a difference in pain perception by patients when the assistant port size varies by 50% (8 mm to 12 mm).
Interventions
PROCEDURE8mm port
Participate in this arm will have their procedure performed with an 8mm laparoscopic port.
PROCEDURE12mm port
Participate in this arm will have their procedure performed with a 12mm laparoscopic port.
Sponsors
Loyola University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* laparoscopic surgery for pelvic organ prolapse. * proficiency in English .
Exclusion criteria
* Not proficiency in English * Previous participation/randomization in the study at a previous visit * Pregnant women cannot participate * History of abdominal wall pain * Chronic pain patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants will be asked to specify the point that represents their level of perceived pain intensity and mark it on the VAS at four time points. | 2 weeks post-op visit | Measured with Visual Analog Scale (VAS) for pain at 1) baseline pain prior to the procedure in the pre-operatively holding area, 2) 4-6 hours post-operatively in the post-anesthesia care unit (PACU), 3) on post-operative day 1(POD1) and 4) once two weeks post operatively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| What is the physician's perception of operative difficulty throughout the case? Determination of physician struggle and frustration will be documented. | Day of surgery | This will be measured by recording the time the first suture is placed when the physician asks for the mesh, to the time the incision is closed. |
Countries
United States
Outcome results
None listed