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

Laparoscopic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04642118
• Other study ID #: 147/2563
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: September 10, 2021

Study information

• Verified date: August 2020
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 10, 2021
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gynecologic Disease
• Laparoscopic Surgery
• Shoulder Pain

Intervention

Procedure:
• Pulmonary recruitment maneuver
Using setting pressure form ventilator to increase pulmonary pressure by compress balloon bag 5 times, 5 seconds per time

Locations

Country	Name	City	State
Thailand	Rajavithi hospital	Bankok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Lung complication	Number of participants with complication (incident) such as pneumothorax, Lung atelectasis, Pleural effusion etc. will be recorded	after surgery in day 1
Secondary	GI discomfort	number of symptom	during stay in hospital around 2-3 days
Secondary	Time to hospital staying	record day which stay in hospital with abnormal condition	During stay in hospital around 2-3 days
Secondary	Administered additional analgesics	number of morphine using	During stay in hospital around 2-3 days