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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by University of Tennessee.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
University of Tennessee Identifier:
First received: November 15, 2013
Last updated: January 3, 2014
Last verified: January 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 Intervention
Shoulder Pain
Procedure: Active lavage and suction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Prevention
Official Title: Lavage and Suction of the Right Upper Quadrant to Reduce Post Laparoscopic Shoulder Pain: A Randomized Controlled Trial

Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 100
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)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT02004470

Contact: Maryam Hadiashar, MD 4086051927

United States, Tennessee
Erlanger Medical Center Not yet recruiting
Chattanooga, Tennessee, United States, 37403
Memorial Hospital
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
Sponsors and Collaborators
University of Tennessee
Principal Investigator: Maryam Hadiashar, MD University of Tennessee Chattanooga College of Medicine
  More Information

Responsible Party: University of Tennessee Identifier: NCT02004470     History of Changes
Other Study ID Numbers: LAS-37405
Study First Received: November 15, 2013
Last Updated: January 3, 2014

Keywords provided by University of Tennessee:
post laparoscopic shoulder pain
active suction
lavage and suction
right shoulder pain
post operative shoulder pain

Additional relevant MeSH terms:
Shoulder Pain
Joint Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on May 25, 2017