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

Study Overview
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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.

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

Conditions
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Shoulder Pain

Intervention / Treatment
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* Procedure: Active lavage and suction


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Passive exsufflation<br>Will not actively suction carbon dioxide from abdomen. Open laparoscopic trocars and allow C02 to passively empty from abdomen. | |
| Experimental: Active lavage and suction<br>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<br>* Active lavage and suction of the right upper quadrant will be performed as the laparoscopic procedure is about to be terminated.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post laparoscopic shoulder pain, active suction, lavage and suction, right shoulder pain, post operative shoulder pain