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Completed

NCT Number: NCT02521987

Port Size and Post-Operative Pain Perception by Patients

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).

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

8mm port

Procedure

Participate in this arm will have their procedure performed with an 8mm laparoscopic port.

12mm port

Procedure

Participate in this arm will have their procedure performed with a 12mm laparoscopic port.

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. What is the physician's perception of operative difficulty throughout the case? Determination of physician struggle and frustration will be documented.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Loyola University

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 13, 2015
Registry last updated
Feb 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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