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

NCT ID: NCT02004470

Last Updated: 2014-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Passive exsufflation

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Active lavage and suction

Intervention Type PROCEDURE

Active lavage and suction of the right upper quadrant will be performed as the laparoscopic procedure is about to be terminated.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Tennessee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maryam Hadiashar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee Chattanooga College of Medicine

Locations

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Erlanger Medical Center

Chattanooga, Tennessee, United States

Site Status

Memorial Hospital

Chattanooga, Tennessee, United States

Site Status

Parkridge East Hospital

Chattanooga, Tennessee, United States

Site Status

Erlanger East Hospital

Chattanooga, Tennessee, United States

Site Status

Countries

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United States

Central Contacts

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Maryam Hadiashar, MD

Role: CONTACT

4086051927

References

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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.

Reference Type BACKGROUND
PMID: 22184293 (View on PubMed)

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.

Reference Type RESULT
PMID: 23635614 (View on PubMed)

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.

Reference Type RESULT
PMID: 18448749 (View on PubMed)

Other Identifiers

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LAS-37405

Identifier Type: -

Identifier Source: org_study_id

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