Lavage and Suction of the Right Upper Quadrant to Reduce Post Laparoscopic Shoulder Pain

Shoulder Pain Clinical Trial

Official title:

Lavage and Suction of the Right Upper Quadrant to Reduce Post Laparoscopic Shoulder Pain: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02004470
• Other study ID #: LAS-37405
• Status: Not yet recruiting
• Phase: N/A
• First received: November 15, 2013
• Last updated: January 3, 2014
• Start date: January 2014
• Est. completion date: June 2014

Study information

• Verified date: January 2014
• Source: University of Tennessee
• Contact: Maryam Hadiashar, MD
• Phone: 4086051927
• Email: maryamhad[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Erlanger East Hospital	Chattanooga	Tennessee
United States	Erlanger Medical Center	Chattanooga	Tennessee
United States	Memorial Hospital	Chattanooga	Tennessee
United States	Parkridge East Hospital	Chattanooga	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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):526-31. doi: 10.1097/AOG.0b013e318283fcca. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score	We will assess pain scores based on visual analog score from 1-10 at 12 hours postoperatively.	12 hours	No
Primary	Pain Score	We will assess a pain score at 24 hours post operatively based on a visual analog score of 1-10	24 hours	No
Primary	Pain Score	We will assess a pain score based on a visual analog score of 1-10 at 48 hours post operatively.	48 hours	No
Secondary	operative time	We will assess how long each surgery takes to complete.	24 hours	No
Secondary	blood loss	We will assess intraoperative blood loss.	6 hours	No
Secondary	analgesic use	We will assess total analgesic, iv and oral used over the course of 7 days postoperatively.	7 days	No
Secondary	Anti emetic use	Total amount of intravenous and oral narcotic used postoperatively.	48 hours	No