Gynecologic Diseases
Conditions
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.
Interventions
PROCEDUREPassive 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.
PROCEDURENormal 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.
PROCEDURENormal 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.
Sponsors
Kangbuk Samsung Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder pain evaluated by 10 point visual analogue scale | after two day of procedure | The pain score was evaluated by 10 point visual analogue scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound pain evaluated by 10 point visual analogue scale | after two day of procedure | The pain score was evaluated by 10 point visual analogue scale. |
Countries
South Korea
Outcome results
None listed