Port Size and Post-Operative Pain Perception by Patients

Loyola University

Status: Completed

Conditions: Pain

Treatments: Procedure: 12mm port; Procedure: 8mm port

Study type: Interventional

Funder types: Other

Identifiers

NCT02521987

207726

Details and patient eligibility

About

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).

Full 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).

Enrollment: 35 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

35 participants in 2 patient groups

8mm Port

Active Comparator group

Description:

Participates 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.

Treatment:

Procedure: 8mm port

12mm Port

Experimental group

Description:

Participates 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.

Treatment:

Procedure: 12mm port