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

Rajavithi Hospital

Status: Completed

Conditions: Laparoscopic Surgery; Gynecologic Disease

Treatments: Procedure: Pulmonary recruitment maneuver

Study type: Interventional

Funder types: Other

Identifiers

NCT04642118

147/2563

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 3 patient groups

Pulmonary recruitment maneuver 30 cmH2O

Experimental group

Description:

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

Treatment:

Procedure: Pulmonary recruitment maneuver

Pulmonary recruitment maneuver 40 cmH2O

Active Comparator group

Description:

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

Treatment:

Procedure: Pulmonary recruitment maneuver

Control

No Intervention group

Description:

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.