Back to resultsEffective Maneuver for Post-laparoscopic Shoulder Pain
Primary Purpose
Gynecologic Diseases
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Passive Deflation
Normal Saline Instillation
Normal Saline Instillation + Pulmonary Recruitment
Sponsored by
About this trial
This is an interventional prevention trial for Gynecologic Diseases
Eligibility 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
Sites / Locations
- Kangbuk Samsung Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Control
Normal Saline Instillation
Combined Intervention
Arm Description
Passive deflation of residual carbon dioxide
Instillation of isotonic normal saline in the sub-diaphragmatic region
Normal Saline Instillation + Pulmonary Recruitment
Outcomes
Primary Outcome Measures
Shoulder pain evaluated by 10 point visual analogue scale
The pain score was evaluated by 10 point visual analogue scale.
Secondary Outcome Measures
Wound pain evaluated by 10 point visual analogue scale
The pain score was evaluated by 10 point visual analogue scale.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02811081
Brief Title
Effective Maneuver for Post-laparoscopic Shoulder Pain
Official Title
The Effective Maneuver to Reduce Shoulder Pain After Laparoscopic Gynecologic Surgery: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
June 26, 2016 (Actual)
Primary Completion Date
April 19, 2017 (Actual)
Study Completion Date
July 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kangbuk Samsung Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Experimental
Arm Description
Passive deflation of residual carbon dioxide
Arm Title
Normal Saline Instillation
Arm Type
Experimental
Arm Description
Instillation of isotonic normal saline in the sub-diaphragmatic region
Arm Title
Combined Intervention
Arm Type
Experimental
Arm Description
Normal Saline Instillation + Pulmonary Recruitment
Intervention Type
Procedure
Intervention Name(s)
Passive Deflation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Normal Saline Instillation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Normal Saline Instillation + Pulmonary Recruitment
Intervention Description
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 Measure Information:
Title
Shoulder pain evaluated by 10 point visual analogue scale
Description
The pain score was evaluated by 10 point visual analogue scale.
Time Frame
after two day of procedure
Secondary Outcome Measure Information:
Title
Wound pain evaluated by 10 point visual analogue scale
Description
The pain score was evaluated by 10 point visual analogue scale.
Time Frame
after two day of procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taejong Song, MD PhD
Organizational Affiliation
Kangbuk Samsung Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effective Maneuver for Post-laparoscopic Shoulder Pain
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