Effective Maneuver for Post-laparoscopic Shoulder Pain

Study Overview
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Brief Summary
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The aim of this clinical trial is to estimate the efficacy and safety of combined intervention with the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver for reducing post-laparoscopic shoulder pain.

Detailed Description
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Shoulder pain after laparoscopy is common and its probable mechanism is residual carbon dioxide gas after surgery. Both the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver could effectively reduce post-laparoscopic shoulder pain. However, the efficacy and safety of combined intervention with normal saline instillation and pulmonary recruitment maneuver have not been investigated yet. The aim of this clinical trial is to estimate the effectiveness of combined intervention with the intra-peritoneal normal saline instillation and pulmonary recruitment maneuver for reducing post-laparoscopic shoulder pain.

Official Title
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The Effective Maneuver to Reduce Shoulder Pain After Laparoscopic Gynecologic Surgery: Randomized Controlled Trial

Conditions
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Gynecologic Diseases

Intervention / Treatment
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* Procedure: Passive Deflation
* Procedure: Normal Saline Instillation
* Procedure: Normal Saline Instillation + Pulmonary Recruitment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing laparoscopy for benign gynecologic diseases patients aged 19-65 years patients with american society of anesthesiology physical status I-II patients obtaining written informed consent Exclusion Criteria: patients with chronic shoulder pain, chronic epigastric pain or chronic pain syndrome patients with past history of pneumothorax or any pulmonary surgical history patients with any shoulder surgery histories patients who required to conversion to open surgery from laparoscopic surgery patients who required to receive incidental upper abdominal surgeries due to adhesion and injury at upper abdominal cavity patients with inability to understand or express 10 point visual analogue scale pregnant women

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control<br>Passive deflation of residual carbon dioxide | Procedure: Passive Deflation<br>* In the control group, residual carbon dioxide gas was evacuated by the routine method using passive exsufflation through the port site at the end of surgery.<br>|
| Experimental: Normal Saline Instillation<br>Instillation of isotonic normal saline in the sub-diaphragmatic region | Procedure: Normal Saline Instillation<br>* In the normal saline instillation group, in addition to the routine method, the patients were placed in the Trendelenburg position (30°), isotonic normal saline (20 ml/kg of body weight) was infused in the sub-diaphragmatic region at the end of surgery.<br>|
| Experimental: Combined Intervention<br>Normal Saline Instillation + Pulmonary Recruitment | Procedure: Normal Saline Instillation + Pulmonary Recruitment<br>* In the combined intervention group, in addition to the routine method, the patients were placed in the Trendelenburg position (30°), and a pulmonary recruitment maneuver was performed after instillation of isotonic normal saline (20 ml/kg of body weight) in the sub-diaphragmatic region at the end of surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder pain evaluated by 10 point visual analogue scale | The pain score was evaluated by 10 point visual analogue scale. | after two day of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound pain evaluated by 10 point visual analogue scale | The pain score was evaluated by 10 point visual analogue scale. | after two day of procedure |