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

NCT ID: NCT04642118

Last Updated: 2021-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2021-09-10

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.

Conditions

Gynecologic Disease; Laparoscopic Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pulmonary recruitment maneuver 30 cmH2O

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

Group Type: EXPERIMENTAL

Pulmonary recruitment maneuver

Intervention Type: PROCEDURE

Using setting pressure form ventilator to increase pulmonary pressure by compress balloon bag 5 times, 5 seconds per time

Pulmonary recruitment maneuver 40 cmH2O

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

Group Type: ACTIVE_COMPARATOR

Pulmonary recruitment maneuver

Intervention Type: PROCEDURE

Using setting pressure form ventilator to increase pulmonary pressure by compress balloon bag 5 times, 5 seconds per time

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pulmonary recruitment maneuver

Using setting pressure form ventilator to increase pulmonary pressure by compress balloon bag 5 times, 5 seconds per time

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Department of Medical Services Ministry of Public Health of Thailand

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anon Yodruangwong

Role: STUDY_DIRECTOR

Resident

Locations

Rajavithi hospital

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

147/2563

Identifier Type: -

Identifier Source: org_study_id