Port Size and Post-Operative Pain Perception by Patients

N/ACompletedNCT02521987

Loyola University35 enrolled

Overview

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).

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Pain

Interventions

8mm portPROCEDURE

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

12mm portPROCEDURE

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

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Locations (1)

Loyola University Medical Center

Maywood, Illinois, United States

Outcomes

Primary Outcomes

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.

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.

Time frame: 2 weeks post-op visit

Secondary Outcomes

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

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.

Time frame: Day of surgery

Data from ClinicalTrials.gov

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