Clinical trial NCT02004470: Lavage and Suction of the Right Upper Quadrant to Reduce Post Laparoscopic Shoulder Pain
Official title: Lavage and Suction of the Right Upper Quadrant to Reduce Post Laparoscopic Shoulder Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Pain
Keywords: post laparoscopic shoulder pain
active suction
lavage and suction
right shoulder pain
post operative shoulder pain
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* English speaking patient
* Female
* Age 18-75
* must undergo laparoscopic surgery
* willing to participate in the study

Exclusion Criteria:

* Male patients
* Under 18 or older than 75
* Laparoscopic procedures that get converted to laparotomy
* Intraoperative hemorrhage more than 500 cc
* Patients with active joint disease
* History of shoulder surgery
* Intraoperative laceration to the liver
* Malignancy
* Long term daily narcotic use
* Chronic right upper quadrant/ shoulder pain
* Pregnancy
* History of dementia, Alzheimers, stroke or other condition causing altered mental status

Primary outcomes:
measure: Pain Score
timeFrame: 12 hours
measure: Pain Score
timeFrame: 24 hours
measure: Pain Score
timeFrame: 48 hours
Secondary outcomes:
measure: operative time
timeFrame: 24 hours
measure: blood loss
timeFrame: 6 hours
measure: analgesic use
timeFrame: 7 days
measure: Anti emetic use
timeFrame: 48 hours
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: Erlanger Medical Center
state: Tennessee
city: Chattanooga
country: United States
facility: Memorial Hospital
state: Tennessee
city: Chattanooga
country: United States
facility: Parkridge East Hospital
state: Tennessee
city: Chattanooga
country: United States
facility: Erlanger East Hospital
state: Tennessee
Study officials:
affiliation: University of Tennessee Chattanooga College of Medicine
name: Maryam Hadiashar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsai HW, Chen YJ, Ho CM, Hseu SS, Chao KC, Tsai SK, Wang PH. Maneuvers to decrease laparoscopy-induced shoulder and upper abdominal pain: a randomized controlled study. Arch Surg. 2011 Dec;146(12):1360-6. doi: 10.1001/archsurg.2011.597.
citation: Tsai HW, Wang PH, Yen MS, Chao KC, Hsu TF, Chen YJ. Prevention of postlaparoscopic shoulder and upper abdominal pain: a randomized controlled trial. Obstet Gynecol. 2013 Mar;121(3):526-531. doi: 10.1097/AOG.0b013e318283fcca.
citation: Phelps P, Cakmakkaya OS, Apfel CC, Radke OC. A simple clinical maneuver to reduce laparoscopy-induced shoulder pain: a randomized controlled trial. Obstet Gynecol. 2008 May;111(5):1155-60. doi: 10.1097/AOG.0b013e31816e34b4.