Effective Maneuver for Post-laparoscopic Shoulder Pain
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|ClinicalTrials.gov Identifier: NCT02811081|
Recruitment Status : Completed
First Posted : June 23, 2016
Last Update Posted : May 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gynecologic Diseases||Procedure: Passive Deflation Procedure: Normal Saline Instillation Procedure: Normal Saline Instillation + Pulmonary Recruitment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||The Effective Maneuver to Reduce Shoulder Pain After Laparoscopic Gynecologic Surgery: Randomized Controlled Trial|
|Actual Study Start Date :||June 26, 2016|
|Actual Primary Completion Date :||April 19, 2017|
|Actual Study Completion Date :||July 30, 2017|
Passive deflation of residual carbon dioxide
Procedure: Passive Deflation
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.
Experimental: Normal Saline Instillation
Instillation of isotonic normal saline in the sub-diaphragmatic region
Procedure: Normal Saline Instillation
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.
Experimental: Combined Intervention
Normal Saline Instillation + Pulmonary Recruitment
Procedure: Normal Saline Instillation + Pulmonary Recruitment
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.
- Shoulder pain evaluated by 10 point visual analogue scale [ Time Frame: after two day of procedure ]The pain score was evaluated by 10 point visual analogue scale.
- Wound pain evaluated by 10 point visual analogue scale [ Time Frame: after two day of procedure ]The pain score was evaluated by 10 point visual analogue scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811081
|Korea, Republic of|
|Kangbuk Samsung Hospital|
|Seoul, Korea, Republic of, 03181|
|Principal Investigator:||Taejong Song, MD PhD||Kangbuk Samsung Hospital|