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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
Sponsor:
Information provided by (Responsible Party):
Kyoungho Ryu, Kangbuk Samsung Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gynecologic Diseases Procedure: Passive Deflation Procedure: Normal Saline Instillation Procedure: Normal Saline Instillation + Pulmonary Recruitment Not Applicable

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Arm Intervention/treatment
Experimental: Control
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Kangbuk Samsung Hospital
Seoul, Korea, Republic of, 03181
Sponsors and Collaborators
Kangbuk Samsung Hospital
Investigators
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Principal Investigator: Taejong Song, MD PhD Kangbuk Samsung Hospital
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Responsible Party: Kyoungho Ryu, Clinical assistant professor, Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier: NCT02811081    
Other Study ID Numbers: 2016-05-048
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations