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

NCT02004470 | Unknown

• 1 other identifier: LAS-37405
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Shoulder Pain

Keywords

post laparoscopic shoulder pain; active suction; lavage and suction; right shoulder pain; post operative shoulder pain

Outcome Measures

Primary Outcomes (3)

• Pain Score

  We will assess pain scores based on visual analog score from 1-10 at 12 hours postoperatively.

  12 hours

• Pain Score

  We will assess a pain score at 24 hours post operatively based on a visual analog score of 1-10

  24 hours

• Pain Score

  We will assess a pain score based on a visual analog score of 1-10 at 48 hours post operatively.

  48 hours

Secondary Outcomes (4)

• operative time

  24 hours

• blood loss

  6 hours

• analgesic use

  7 days

• Anti emetic use

  48 hours

Study Arms (2)

Passive exsufflation

NO INTERVENTION

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

Active lavage and suction

EXPERIMENTAL

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

Interventions

Active lavage and suction PROCEDURE

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

Active lavage and suction

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking patient
• Female
• Age 18-75
• must undergo laparoscopic surgery
• willing to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (4)

Erlanger Medical Center

Chattanooga, Tennessee, 37403, United States

Location

Memorial Hospital

Chattanooga, Tennessee, 37404, United States

Location

Parkridge East Hospital

Chattanooga, Tennessee, 37412, United States

Location

Erlanger East Hospital

Chattanooga, Tennessee, 37421, United States

Location

Related Publications (3)

• 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.

  PMID: 22184293 BACKGROUND

• 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.

  PMID: 23635614 RESULT

• 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.

  PMID: 18448749 RESULT

MeSH Terms

Conditions

Shoulder Pain

Interventions

Suction

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drainage; Surgical Procedures, Operative

Study Officials

• Maryam Hadiashar, MD

  University of Tennessee Chattanooga College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maryam Hadiashar, MD

CONTACT

4086051927; maryamhad@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: December 9, 2013
• Study Start: January 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 6, 2014

Record last verified: 2014-01

Locations

US (4)