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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Experimental | Passive deflation of residual carbon dioxide |
|
| Normal Saline Instillation | Experimental | Instillation of isotonic normal saline in the sub-diaphragmatic region |
|
| Combined Intervention | Experimental | Normal Saline Instillation + Pulmonary Recruitment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Passive Deflation | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taejong Song, MD PhD | Kangbuk Samsung Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
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| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| Normal Saline Instillation | Procedure | 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. |
|
| Normal Saline Instillation + Pulmonary Recruitment | Procedure | 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. |
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