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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by University of Tennessee
Sponsor:
Information provided by (Responsible Party):
University of Tennessee
ClinicalTrials.gov Identifier:
NCT02004470
First received: November 15, 2013
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]
    We will assess pain scores based on visual analog score from 1-10 at 12 hours postoperatively.

  • Pain Score [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    We will assess how long each surgery takes to complete.

  • blood loss [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    We will assess intraoperative blood loss.

  • analgesic use [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    We will assess total analgesic, iv and oral used over the course of 7 days postoperatively.

  • Anti emetic use [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02004470

Contacts
Contact: Maryam Hadiashar, MD 4086051927 maryamhad@gmail.com

Locations
United States, Tennessee
Erlanger Medical Center Not yet recruiting
Chattanooga, Tennessee, United States, 37403
Erlanger East Hospital Not yet recruiting
Chattanooga, Tennessee, United States, 37421
Parkridge East Hospital Not yet recruiting
Chattanooga, Tennessee, United States, 37412
Memorial Hospital
Chattanooga, Tennessee, United States, 37404
Sponsors and Collaborators
University of Tennessee
Investigators
Principal Investigator: Maryam Hadiashar, MD University of Tennessee Chattanooga College of Medicine
  More Information

Publications:
Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT02004470     History of Changes
Other Study ID Numbers: LAS-37405
Study First Received: November 15, 2013
Last Updated: January 3, 2014
Health Authority: United States: Institutional Review Board

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
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014