Clinical trial NCT04642118: Low-pressure Pulmonary Recruitment Maneuver to Decrease Post-laparoscopic Shoulder Pain in Gynecologic Surgery
Official title: Low-pressure Pulmonary Recruitment Maneuver to Decrease Post-laparoscopic Shoulder Pain in Gynecologic Surgery: A Double-blind Randomized Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Disease
Laparoscopic Surgery
Keywords: Low pressure
Pulmonary Recruitment Maneuver
Post-laparoscopic Shoulder Pain
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2020-11-24
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: shoulder pain from using PRM 30 cmH2O
timeFrame: During stay in hospital around 2-3 days
Secondary outcomes:
measure: wound pain
timeFrame: During stay in hospital around 2-3 days
measure: shoulder pain from using PRM 40 cmH2O
timeFrame: During stay in hospital around 2-3 days
measure: Post-operative residue pneumoperitoneum
timeFrame: after surgery in day 1
measure: Lung complication
timeFrame: after surgery in day 1
measure: GI discomfort
timeFrame: during stay in hospital around 2-3 days
measure: Time to hospital staying
timeFrame: During stay in hospital around 2-3 days
measure: Administered additional analgesics
timeFrame: During stay in hospital around 2-3 days
Other outcomes:
Locations:
city: Bankok
country: Thailand
facility: Rajavithi hospital
Study officials:
affiliation: Resident
name: Anon Yodruangwong
role: STUDY_DIRECTOR
References: