Lavage and Suction of the Right Upper Quadrant to Reduce Post Laparoscopic Shoulder Pain
Recruitment status was Not yet recruiting
The use of laparoscopy in gynecologic surgery has been well established to decrease morbidity, blood loss, hospital stay, and post-operative pain when compared to traditional open abdominal surgery. However, the laparoscopic technique is associated with post-operative shoulder pain.
We hypothesize that a combination of intraperitoneal saline lavage and active suction removal of carbon dioxide gas from the right upper quadrant of the abdomen will decrease incidence of post-laparoscopic shoulder pain when compared to passive exsufflation of carbon dioxide gas.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||Lavage and Suction of the Right Upper Quadrant to Reduce Post Laparoscopic Shoulder Pain: A Randomized Controlled Trial|
- Pain Score [ Time Frame: 12 hours ] [ Designated as safety issue: No ]We will assess pain scores based on visual analog score from 1-10 at 12 hours postoperatively.
- Pain Score [ Time Frame: 24 hours ] [ Designated as safety issue: No ]We will assess a pain score at 24 hours post operatively based on a visual analog score of 1-10
- Pain Score [ Time Frame: 48 hours ] [ Designated as safety issue: No ]We will assess a pain score based on a visual analog score of 1-10 at 48 hours post operatively.
- operative time [ Time Frame: 24 hours ] [ Designated as safety issue: No ]We will assess how long each surgery takes to complete.
- blood loss [ Time Frame: 6 hours ] [ Designated as safety issue: No ]We will assess intraoperative blood loss.
- analgesic use [ Time Frame: 7 days ] [ Designated as safety issue: No ]We will assess total analgesic, iv and oral used over the course of 7 days postoperatively.
- Anti emetic use [ Time Frame: 48 hours ] [ Designated as safety issue: No ]Total amount of intravenous and oral narcotic used postoperatively.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
No Intervention: Passive exsufflation
Will not actively suction carbon dioxide from abdomen. Open laparoscopic trocars and allow C02 to passively empty from abdomen.
Experimental: Active lavage and suction
This step is already employed in many ongoing surgeries where normal saline will be used to lavage the right upper quadrant and then will be suctioned out to remove as much Carbon dioxide from the patient's abdomen and to therefore decrease postoperative pain.
Procedure: Active lavage and suction
Active lavage and suction of the right upper quadrant will be performed as the laparoscopic procedure is about to be terminated.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02004470
|Contact: Maryam Hadiashar, MDfirstname.lastname@example.org|
|United States, Tennessee|
|Erlanger Medical Center||Not yet recruiting|
|Chattanooga, Tennessee, United States, 37403|
|Chattanooga, Tennessee, United States, 37404|
|Parkridge East Hospital||Not yet recruiting|
|Chattanooga, Tennessee, United States, 37412|
|Erlanger East Hospital||Not yet recruiting|
|Chattanooga, Tennessee, United States, 37421|
|Principal Investigator:||Maryam Hadiashar, MD||University of Tennessee Chattanooga College of Medicine|