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

Primary Purpose

Gynecologic Disease, Laparoscopic Surgery

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Pulmonary recruitment maneuver
Sponsored by
Rajavithi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gynecologic Disease focused on measuring Low pressure, Pulmonary Recruitment Maneuver, Post-laparoscopic Shoulder Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Rajavithi hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Pulmonary recruitment maneuver 30 cmH2O

Pulmonary recruitment maneuver 40 cmH2O

Control

Arm 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

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

wound pain
evaluate with Visual analogue scale from score 0(no pain) to score 10 (maximum pain)
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.
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
Lung complication
Number of participants with complication (incident) such as pneumothorax, Lung atelectasis, Pleural effusion etc. will be recorded
GI discomfort
number of symptom
Time to hospital staying
record day which stay in hospital with abnormal condition
Administered additional analgesics
number of morphine using

Full Information

First Posted
August 28, 2020
Last Updated
September 10, 2021
Sponsor
Rajavithi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04642118
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
July 20, 2021 (Actual)
Study Completion Date
September 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajavithi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Disease, Laparoscopic Surgery
Keywords
Low pressure, Pulmonary Recruitment Maneuver, Post-laparoscopic Shoulder Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulmonary recruitment maneuver 30 cmH2O
Arm Type
Experimental
Arm 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
Arm Title
Pulmonary recruitment maneuver 40 cmH2O
Arm Type
Active Comparator
Arm 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
Arm Title
Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Pulmonary recruitment maneuver
Intervention Description
Using setting pressure form ventilator to increase pulmonary pressure by compress balloon bag 5 times, 5 seconds per time
Primary Outcome Measure Information:
Title
shoulder pain from using PRM 30 cmH2O
Description
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.
Time Frame
During stay in hospital around 2-3 days
Secondary Outcome Measure Information:
Title
wound pain
Description
evaluate with Visual analogue scale from score 0(no pain) to score 10 (maximum pain)
Time Frame
During stay in hospital around 2-3 days
Title
shoulder pain from using PRM 40 cmH2O
Description
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.
Time Frame
During stay in hospital around 2-3 days
Title
Post-operative residue pneumoperitoneum
Description
Residue air volume in abdominal cavity will be measured (Hight from diaphragm to upper border of liver (cm.)) from Chest x-ray PA upright
Time Frame
after surgery in day 1
Title
Lung complication
Description
Number of participants with complication (incident) such as pneumothorax, Lung atelectasis, Pleural effusion etc. will be recorded
Time Frame
after surgery in day 1
Title
GI discomfort
Description
number of symptom
Time Frame
during stay in hospital around 2-3 days
Title
Time to hospital staying
Description
record day which stay in hospital with abnormal condition
Time Frame
During stay in hospital around 2-3 days
Title
Administered additional analgesics
Description
number of morphine using
Time Frame
During stay in hospital around 2-3 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anon Yodruangwong
Organizational Affiliation
Resident
Official's Role
Study Director
Facility Information:
Facility Name
Rajavithi hospital
City
Bankok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

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

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