Low-pressure Pulmonary Recruitment Maneuver to Decrease Post-laparoscopic Shoulder Pain in Gynecologic Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Low-pressure Pulmonary Recruitment Maneuver to Decrease Post-laparoscopic Shoulder Pain in Gynecologic Surgery: A Double-blind Randomized Placebo Controlled Trial

Conditions
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Gynecologic Disease, Laparoscopic Surgery

Intervention / Treatment
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* Procedure: Pulmonary recruitment maneuver


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 65 years Anesthesiologists physical status (ASAPS) classification I-II Absence of Pregnancy With inform-consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulmonary recruitment maneuver 30 cmH2O<br>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 | Procedure: Pulmonary recruitment maneuver<br>* Using setting pressure form ventilator to increase pulmonary pressure by compress balloon bag 5 times, 5 seconds per time<br>|
| Active Comparator: Pulmonary recruitment maneuver 40 cmH2O<br>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 | Procedure: Pulmonary recruitment maneuver<br>* Using setting pressure form ventilator to increase pulmonary pressure by compress balloon bag 5 times, 5 seconds per time<br>|
| No Intervention: Control<br>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 not be received any positive pressure from Pulmonary recruiment maneuver [balloon bag] from anesthesiologist. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| shoulder pain from using PRM 30 cmH2O | 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. | During stay in hospital around 2-3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound pain | evaluate with Visual analogue scale from score 0(no pain) to score 10 (maximum pain) | During stay in hospital around 2-3 days | 
| shoulder pain from using PRM 40 cmH2O | 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. | During stay in hospital around 2-3 days | 
| Post-operative residue pneumoperitoneum | Residue air volume in abdominal cavity will be measured (Hight from diaphragm to upper border of liver (cm.)) from Chest x-ray PA upright | after surgery in day 1 | 
| Lung complication | Number of participants with complication (incident) such as pneumothorax, Lung atelectasis, Pleural effusion etc. will be recorded | after surgery in day 1 | 
| GI discomfort | number of symptom | during stay in hospital around 2-3 days | 
| Time to hospital staying | record day which stay in hospital with abnormal condition | During stay in hospital around 2-3 days | 
| Administered additional analgesics | number of morphine using | During stay in hospital around 2-3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low pressure, Pulmonary Recruitment Maneuver, Post-laparoscopic Shoulder Pain