NCT04642118

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 24, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2021

Completed
Last Updated

September 13, 2021

Status Verified

August 1, 2020

Enrollment Period

10 months

First QC Date

August 28, 2020

Last Update Submit

September 10, 2021

Conditions

Gynecologic DiseaseLaparoscopic Surgery

Keywords

Low pressurePulmonary Recruitment ManeuverPost-laparoscopic Shoulder Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • wound pain

    During stay in hospital around 2-3 days

  • shoulder pain from using PRM 40 cmH2O

    During stay in hospital around 2-3 days

  • Post-operative residue pneumoperitoneum

    after surgery in day 1

  • Lung complication

    after surgery in day 1

  • GI discomfort

    during stay in hospital around 2-3 days

  • +2 more secondary outcomes

Study Arms (3)

Pulmonary recruitment maneuver 30 cmH2O

EXPERIMENTAL

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

Procedure: Pulmonary recruitment maneuver

Pulmonary recruitment maneuver 40 cmH2O

ACTIVE COMPARATOR

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

Procedure: Pulmonary recruitment maneuver

Control

NO INTERVENTION

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.

Interventions

Pulmonary recruitment maneuverPROCEDURE

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

Pulmonary recruitment maneuver 30 cmH2OPulmonary recruitment maneuver 40 cmH2O

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 65 years
  • Anesthesiologists physical status (ASAPS) classification I-II
  • Absence of Pregnancy
  • With inform-consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajavithi hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Genital Diseases, Female

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Anon Yodruangwong

    Resident

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2020

First Posted

November 24, 2020

Study Start

October 1, 2020

Primary Completion

July 20, 2021

Study Completion

September 10, 2021

Last Updated

September 13, 2021

Record last verified: 2020-08

Locations

TH(1)