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

Lavage and Suction of the Right Upper Quadrant to Reduce Post Laparoscopic Shoulder Pain: A Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Shoulder Pain
• Intervention / Treatment: Procedure: Active lavage and suction

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maryam Hadiashar, MD; Phone Number: 4086051927; Email: maryamhad@gmail.com

Study Locations

• United States
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Memorial Hospital
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Medical Center
    • Chattanooga, Tennessee, United States, 37412
      • Parkridge East Hospital
    • Chattanooga, Tennessee, United States, 37421
      • Erlanger East Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time	We will assess how long each surgery takes to complete.	24 hours
blood loss	We will assess intraoperative blood loss.	6 hours
analgesic use	We will assess total analgesic, iv and oral used over the course of 7 days postoperatively.	7 days
Anti emetic use	Total amount of intravenous and oral narcotic used postoperatively.	48 hours

Collaborators and Investigators

• Sponsor: University of Tennessee
• Investigators: Principal Investigator: Maryam Hadiashar, MD, University of Tennessee Chattanooga College of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): April 1, 2014
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: November 15, 2013
• First Submitted That Met QC Criteria: December 4, 2013
• First Posted (Estimate): December 9, 2013

Study Record Updates

• Last Update Posted (Estimate): January 6, 2014
• Last Update Submitted That Met QC Criteria: January 3, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: post laparoscopic shoulder pain; active suction; lavage and suction; right shoulder pain; post operative shoulder pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: LAS-37405