Pulmonary Recruitment Maneuver for Postlaparoscopic Shoulder Pain
1 other identifier
interventional
90
1 country
1
Brief Summary
The aim of this clinical trial is to evaluate the efficacy and safety of different recruitment maneuvers for reducing postlaparoscopic shoulder pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2015
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 2, 2015
CompletedFirst Posted
Study publicly available on registry
November 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedDecember 1, 2016
November 1, 2016
6 months
November 2, 2015
November 29, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Shoulder pain
The pain score was evaluated by 10 point visual analogue scale.
after two day of procedure
Secondary Outcomes (1)
Wound pain
after two day of procedure
Study Arms (3)
Passive deflation
EXPERIMENTALIn the controls, CO2 was removed by the traditional passive deflation of abdominal cavity.
40 cmH2O
EXPERIMENTALThe intervention was five manual inflations of the lungs with positive pressure ventilation of 40 cmH2O at the end of surgery.
60 cmH2O
EXPERIMENTALThe intervention was five manual inflations of the lungs with positive pressure ventilation of 60 cmH2O at the end of surgery.
Interventions
The intervention was five manual inflations of the lungs with positive pressure ventilation of 40 cmH2O at the end of surgery.
The intervention was five manual inflations of the lungs with positive pressure ventilation of 60 cmH2O at the end of surgery.
In the controls, CO2 was removed by the traditional passive deflation of abdominal cavity.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- intrauterine pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kangbuk Samsung Hospital
Seoul, 110-746, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Taejong Song, MD PhD
Kangbuk Samsung Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 2, 2015
First Posted
November 4, 2015
Study Start
November 1, 2015
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
December 1, 2016
Record last verified: 2016-11