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Port Size and Post-Operative Pain Perception by Patients

Not Applicable
Completed
Conditions
Pain
Interventions
Procedure: 12mm port
Procedure: 8mm port
Registration Number
NCT02521987
Lead Sponsor
Loyola University
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).

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
35
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
12mm Port12mm portParticipates will be randomized to have an 12mm assistant port used during their surgery. The participate will be asked to specify the point that represents their level of perceived pain intensity and mark it on the scale at four time points: baseline pain prior to the procedure in the pre-operatively holding area, 4 to 6 hours post operatively, on Post Operative Day 1 (POD1). The final pain assessment will be at the two weeks postoperative clinic visit.
8mm Port8mm portParticipates will be randomized to have an 8 mm assistant port used during their surgery. The participate will be asked to specify the point that represents their level of perceived pain intensity and mark it on the scale at four time points: baseline pain prior to the procedure in the pre-operatively holding area, 4 to 6 hours post operatively, on Post Operative Day 1 (POD1). The final pain assessment will be at the two weeks postoperative clinic visit.
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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.

Trial Locations

Locations (1)

Loyola University Medical Center

🇺🇸

Maywood, Illinois, United States

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