Gynecologic Disease, Laparoscopic Surgery
Conditions
Keywords
Low pressure, Pulmonary Recruitment Maneuver, Post-laparoscopic Shoulder Pain
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.
Interventions
PROCEDUREPulmonary recruitment maneuver
Using setting pressure form ventilator to increase pulmonary pressure by compress balloon bag 5 times, 5 seconds per time
Sponsors
Department of Medical Services Ministry of Public Health of Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| GI discomfort | during stay in hospital around 2-3 days | number of symptom |
Countries
Thailand
Outcome results
None listed