Rajavithi hospital
Bangkok, 10400, Thailand
NCT Number: NCT04642118
Research objective to compare outcomes (shoulder pain score, wound pain score, post-operative residual pneumoperitoneum, lung complication, GI discomfort, administered additional analgesics, time to hospital staying) of using Pulmonary Recruitment maneuver with pressure 30 cmH2O, 40 cm H2O and control group in women with post laparoscopic gynecologic surgery in Rajavithi hospital.
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Notify Me18 year–65 year
Female
Interventional
Not applicable
Bangkok, 10400, Thailand
Research design is Randomized control trial. The women who go to laparoscopic gynecologic surgery don't know the allocation. Women will be randomizes in to 3 group: PRM 30 cmH2O, 40 cmH2O and control
After laparoscopic surgery has finished in operator room (before moving off trocar), woman all group will be set in Trenderlenberg position (Tilted head low) and then surgeon will compress abdomen to release residual gas after operation about 2 minutes.
The patients in group of using Pulmonary Recruitment Maneuver will be received positive pressure from balloon bag from anesthesiologist 5 times of setting pressure [30 cmH2O, 40 cmH2O], 5 seconds per time to increase indirect abdominal pressure to release residual gas
After surgery at 12, 24 and 48 hours, patients will be follow up and evaluate shoulder and wound pain. Chest X-ray will be done to evaluate residual pneumoperitoneum and lung complication. GI discomfort, administered additional analgesics and time to hospital staying will be evaluated and recorded.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Using setting pressure form ventilator to increase pulmonary pressure by compress balloon bag 5 times, 5 seconds per time
Time frame: During stay in hospital around 2-3 days
To compare shoulder pain score(Visual analogue scale from score 0(no pain) to score 10 (maximum pain)) after laparoscopic gynecologic surgery between PRM at 30 cmH2O group and control group at 12, 24 and 48 hrs.
Time frame: During stay in hospital around 2-3 days
evaluate with Visual analogue scale from score 0(no pain) to score 10 (maximum pain)
Time frame: During stay in hospital around 2-3 days
To compare shoulder pain score(Visual analogue scale from score 0(no pain) to score 10 (maximum pain)) after laparoscopic gynecologic surgery between PRM at 40 cmH2O group and control group at 12, 24 and 48 hrs.
Time frame: after surgery in day 1
Residue air volume in abdominal cavity will be measured (Hight from diaphragm to upper border of liver (cm.)) from Chest x-ray PA upright
Time frame: after surgery in day 1
Number of participants with complication (incident) such as pneumothorax, Lung atelectasis, Pleural effusion etc. will be recorded
Time frame: during stay in hospital around 2-3 days
number of symptom
Time frame: During stay in hospital around 2-3 days
record day which stay in hospital with abnormal condition
Time frame: During stay in hospital around 2-3 days
number of morphine using
Department of Medical Services Ministry of Public Health of Thailand
Other Gov
Low-pressure Pulmonary Recruitment Maneuver to Decrease Post-laparoscopic Shoulder Pain in Gynecologic Surgery: A Double-blind Randomized Placebo Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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