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

Primary Purpose

Shoulder Pain

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active lavage and suction
Sponsored by
University of Tennessee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Shoulder Pain focused on measuring post laparoscopic shoulder pain, active suction, lavage and suction, right shoulder pain, post operative shoulder pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Erlanger Medical Center
  • Memorial Hospital
  • Parkridge East Hospital
  • Erlanger East Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Passive exsufflation

Active lavage and suction

Arm Description

Will not actively suction carbon dioxide from abdomen. Open laparoscopic trocars and allow C02 to passively empty from abdomen.

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.

Outcomes

Primary Outcome Measures

Pain Score
We will assess pain scores based on visual analog score from 1-10 at 12 hours postoperatively.
Pain Score
We will assess a pain score at 24 hours post operatively based on a visual analog score of 1-10
Pain Score
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
We will assess how long each surgery takes to complete.
blood loss
We will assess intraoperative blood loss.
analgesic use
We will assess total analgesic, iv and oral used over the course of 7 days postoperatively.
Anti emetic use
Total amount of intravenous and oral narcotic used postoperatively.

Full Information

First Posted
November 15, 2013
Last Updated
January 3, 2014
Sponsor
University of Tennessee
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1. Study Identification

Unique Protocol Identification Number
NCT02004470
Brief Title
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

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tennessee

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
post laparoscopic shoulder pain, active suction, lavage and suction, right shoulder pain, post operative shoulder pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Passive exsufflation
Arm Type
No Intervention
Arm Description
Will not actively suction carbon dioxide from abdomen. Open laparoscopic trocars and allow C02 to passively empty from abdomen.
Arm Title
Active lavage and suction
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Active lavage and suction
Intervention Description
Active lavage and suction of the right upper quadrant will be performed as the laparoscopic procedure is about to be terminated.
Primary Outcome Measure Information:
Title
Pain Score
Description
We will assess pain scores based on visual analog score from 1-10 at 12 hours postoperatively.
Time Frame
12 hours
Title
Pain Score
Description
We will assess a pain score at 24 hours post operatively based on a visual analog score of 1-10
Time Frame
24 hours
Title
Pain Score
Description
We will assess a pain score based on a visual analog score of 1-10 at 48 hours post operatively.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
operative time
Description
We will assess how long each surgery takes to complete.
Time Frame
24 hours
Title
blood loss
Description
We will assess intraoperative blood loss.
Time Frame
6 hours
Title
analgesic use
Description
We will assess total analgesic, iv and oral used over the course of 7 days postoperatively.
Time Frame
7 days
Title
Anti emetic use
Description
Total amount of intravenous and oral narcotic used postoperatively.
Time Frame
48 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maryam Hadiashar, MD
Phone
4086051927
Email
maryamhad@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maryam Hadiashar, MD
Organizational Affiliation
University of Tennessee Chattanooga College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erlanger Medical Center
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Memorial Hospital
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Parkridge East Hospital
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37412
Country
United States
Facility Name
Erlanger East Hospital
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22184293
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.
Results Reference
background
PubMed Identifier
23635614
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.
Results Reference
result
PubMed Identifier
18448749
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.
Results Reference
result

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

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