Low-pressure Pulmonary Recruitment Maneuver to Decrease Post-laparoscopic Shoulder Pain in Gynecologic Surgery
- Conditions
- Laparoscopic SurgeryGynecologic Disease
- Interventions
- Procedure: Pulmonary recruitment maneuver
- Registration Number
- NCT04642118
- Lead Sponsor
- Rajavithi Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 80
- Age between 18 and 65 years
- Anesthesiologists physical status (ASAPS) classification I-II
- Absence of Pregnancy
- With inform-consent
- Inability to accurately express pain
- Past history of shoulder or lung surgery
- Chronic shoulder problem
- Epigastric pain
- Lung disease such as emphysema or pneumothorax
- Severe kidney or liver disease
- Drug allergy (NSAIDs, Paracetamol)
- On current medication: corticosteroid
- Psychiatric disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pulmonary recruitment maneuver 40 cmH2O Pulmonary recruitment maneuver After laparoscopic surgery has finished in operator room (before moving off trocar), patient 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 this group will be received positive pressure from Pulmonary recruiment maneuver \[balloon bag\] from anesthesiologist 5 times of setting pressure 40 cmH2O, 5 seconds per time to increase indirect abdominal pressure to release residual gas Pulmonary recruitment maneuver 30 cmH2O Pulmonary recruitment maneuver After laparoscopic surgery has finished in operator room (before moving off trocar), patient 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 this group will be received positive pressure from Pulmonary recruiment maneuver \[balloon bag\] from anesthesiologist 5 times of setting pressure 30 cmH2O, 5 seconds per time to increase indirect abdominal pressure to release residual gas
- Primary Outcome Measures
Name Time Method shoulder pain from using PRM 30 cmH2O 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.
- Secondary Outcome Measures
Name Time Method shoulder pain from using PRM 40 cmH2O 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.
Post-operative residue pneumoperitoneum 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
Lung complication after surgery in day 1 Number of participants with complication (incident) such as pneumothorax, Lung atelectasis, Pleural effusion etc. will be recorded
wound pain During stay in hospital around 2-3 days evaluate with Visual analogue scale from score 0(no pain) to score 10 (maximum pain)
GI discomfort during stay in hospital around 2-3 days number of symptom
Time to hospital staying During stay in hospital around 2-3 days record day which stay in hospital with abnormal condition
Administered additional analgesics During stay in hospital around 2-3 days number of morphine using
Trial Locations
- Locations (1)
Rajavithi hospital
🇹🇭Bankok, Thailand