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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
University of Tennessee

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.

Condition or disease Intervention/treatment Phase
Shoulder Pain Procedure: Active lavage and suction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Pain Score [ Time Frame: 12 hours ]
    We will assess pain scores based on visual analog score from 1-10 at 12 hours postoperatively.

  2. 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

  3. 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 :
  1. operative time [ Time Frame: 24 hours ]
    We will assess how long each surgery takes to complete.

  2. blood loss [ Time Frame: 6 hours ]
    We will assess intraoperative blood loss.

  3. analgesic use [ Time Frame: 7 days ]
    We will assess total analgesic, iv and oral used over the course of 7 days postoperatively.

  4. Anti emetic use [ Time Frame: 48 hours ]
    Total amount of intravenous and oral narcotic used postoperatively.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02004470

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Contact: Maryam Hadiashar, MD 4086051927

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United States, Tennessee
Erlanger Medical Center
Chattanooga, Tennessee, United States, 37403
Memorial Hospital
Chattanooga, Tennessee, United States, 37404
Parkridge East Hospital
Chattanooga, Tennessee, United States, 37412
Erlanger East Hospital
Chattanooga, Tennessee, United States, 37421
Sponsors and Collaborators
University of Tennessee
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Principal Investigator: Maryam Hadiashar, MD University of Tennessee Chattanooga College of Medicine
Publications of Results:
Other Publications:
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Responsible Party: University of Tennessee Identifier: NCT02004470    
Other Study ID Numbers: LAS-37405
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: January 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:
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Shoulder Pain
Joint Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Signs and Symptoms