Lavage and Suction of the Right Upper Quadrant to Reduce Post Laparoscopic Shoulder Pain
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|ClinicalTrials.gov Identifier: NCT02004470|
Recruitment Status : Unknown
Verified January 2014 by University of Tennessee.
Recruitment status was: Not yet recruiting
First Posted : December 9, 2013
Last Update Posted : January 6, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Shoulder Pain||Procedure: Active lavage and suction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Lavage and Suction of the Right Upper Quadrant to Reduce Post Laparoscopic Shoulder Pain: A Randomized Controlled Trial|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||June 2014|
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.
- Pain Score [ Time Frame: 12 hours ]We will assess pain scores based on visual analog score from 1-10 at 12 hours postoperatively.
- Pain Score [ Time Frame: 24 hours ]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 ]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 ]We will assess how long each surgery takes to complete.
- blood loss [ Time Frame: 6 hours ]We will assess intraoperative blood loss.
- analgesic use [ Time Frame: 7 days ]We will assess total analgesic, iv and oral used over the course of 7 days postoperatively.
- Anti emetic use [ Time Frame: 48 hours ]Total amount of intravenous and oral narcotic used postoperatively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|