Port Size and Post-Operative Pain Perception by Patients

Pain Clinical Trial

Official title:

Port Size and Post-Operative Pain Perception by Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02521987
• Other study ID #: 207726
• Status: Completed
• Phase: N/A
• First received: July 24, 2015
• Last updated: January 30, 2018
• Start date: August 1, 2015
• Est. completion date: November 16, 2017

Study information

• Verified date: January 2018
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 16, 2017
• Est. primary completion date: November 16, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Pain, Postoperative

Intervention

Procedure:
• 8mm port
Participate in this arm will have their procedure performed with an 8mm laparoscopic port.
• 12mm port
Participate in this arm will have their procedure performed with a 12mm laparoscopic port.

Locations

Country	Name	City	State
United States	Loyola University Medical Center	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

References & Publications (4)

Geller EJ, Siddiqui NY, Wu JM, Visco AG. Short-term outcomes of robotic sacrocolpopexy compared with abdominal sacrocolpopexy. Obstet Gynecol. 2008 Dec;112(6):1201-6. doi: 10.1097/AOG.0b013e31818ce394. — View Citation

McDermott CD, Hale DS. Abdominal, laparoscopic, and robotic surgery for pelvic organ prolapse. Obstet Gynecol Clin North Am. 2009 Sep;36(3):585-614. doi: 10.1016/j.ogc.2009.09.004. Review. — View Citation

Nygaard I, Bradley C, Brandt D; Women's Health Initiative. Pelvic organ prolapse in older women: prevalence and risk factors. Obstet Gynecol. 2004 Sep;104(3):489-97. — View Citation

Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks post-op visit
Secondary	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.	Day of surgery