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Pulmonary Recruitment Maneuver With 15 and 30 cmH2O Pressure to Reduce the Postoperative Shoulder Pain

Primary Purpose

Surgery

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pulmonary recruitment maneuver (PRM)- 30 cm H2O
Pulmonary recruitment maneuver (PRM)- 15 cm H2O
Sponsored by
Kanuni Sultan Suleyman Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgery focused on measuring gynecologic laparoscopic surgery, post-laparoscopic shoulder pain, pulmonary recruitment manoeuvre

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Must be scheduled for LS for benign causes
  • Must be American Society of Anesthesiologists (ASA) class I or II.

Exclusion Criteria:

  • Previous lung surgery
  • Preexisting Emphysema
  • Previous Pneumothorax

Sites / Locations

  • Kanuni Sultan Suleyman Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PRM 30 cm H2O

PRM 15 cm H2O

Arm Description

In this group, following the laparoscopic surgery and just before the extubation, patients will receive PRM with 30 cm H2O in the semi-fowler position.

In this group, following the laparoscopic surgery and just before the extubation, patients will receive PRM with 15 cm H2O in the semi-fowler position.

Outcomes

Primary Outcome Measures

Postoperative shoulder pain using a Visual Analogue Scale (VAS) based on a 0-10 scale, with 0 meaning no pain and 10 the most intense pain ever experienced
Change in postoperative shoulder pain between the two PRM pressure groups

Secondary Outcome Measures

Full Information

First Posted
May 29, 2019
Last Updated
October 2, 2019
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03970473
Brief Title
Pulmonary Recruitment Maneuver With 15 and 30 cmH2O Pressure to Reduce the Postoperative Shoulder Pain
Official Title
Pulmonary Recruitment Maneuver With 15 or 30 cmH2O Pressure in Semi-Fowler Position: Which Provides Less Postoperative Shoulder Pain Following Gynecologic Laparoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 2, 2019 (Actual)
Primary Completion Date
August 22, 2019 (Actual)
Study Completion Date
October 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research 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
Pulmonary recruitment maneuver (PRM) has been shown to reduce postoperative shoulder pain by removing excessive intraabdominal gas following laparoscopic surgery(LS). A recent study demonstrated that compared to PRM in the supine position, PRM at semi-fowler position provides better evacuation of the remaining intraabdominal gas following gynecologic LS. This study aimed to compare the impact of PRM with 15 cm H2O and PRM with 30 cm H2O on postoperative shoulder pain in patients undergoing gynecologic LS.
Detailed Description
Pulmonary recruitment maneuver (PRM) consists of five manual pulmonary inflations where each positive pressure inflation was done for 5 s at a maximum pressure of 30-40 cm H2O in the neutral position. When used after laparoscopic surgery and just before the extubation, PRM has been shown to facilitate the removal of intraabdominal gas and thus reduce the postoperative shoulder pain which is associated with the volume of the gas accumulating under the diaphragm. A recent study demonstrated that compared to PRM in the supine position, PRM at semi-fowler position provides better evacuation of the remaining intraabdominal gas and less postoperative shoulder pain following gynecologic LS. However, whether a PRM with lower pressure is also effective in reducing postoperative intraabdominal gas and postoperative shoulder pain is of question. This study aimed to compare the impact of PRM with two pressures (15 cm H2O or 30 cm H2O) in addition to the semi-fowler position on postoperative shoulder pain in patients undergoing gynecologic LS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery
Keywords
gynecologic laparoscopic surgery, post-laparoscopic shoulder pain, pulmonary recruitment manoeuvre

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
PRM 30 cm H2O
Arm Type
Active Comparator
Arm Description
In this group, following the laparoscopic surgery and just before the extubation, patients will receive PRM with 30 cm H2O in the semi-fowler position.
Arm Title
PRM 15 cm H2O
Arm Type
Active Comparator
Arm Description
In this group, following the laparoscopic surgery and just before the extubation, patients will receive PRM with 15 cm H2O in the semi-fowler position.
Intervention Type
Other
Intervention Name(s)
Pulmonary recruitment maneuver (PRM)- 30 cm H2O
Intervention Description
Pulmonary recruitment maneuver (PRM) consists of five manual pulmonary inflations where each positive pressure inflation will be performed for 5 s at a maximum pressure of 30 cm H2O in the semi-fowler position (30° head-of-bed elevation ). PRM is performed after LS when the main umbilical port is remaining and aims to remove the remaining gas following LS.
Intervention Type
Other
Intervention Name(s)
Pulmonary recruitment maneuver (PRM)- 15 cm H2O
Intervention Description
Pulmonary recruitment maneuver (PRM) consists of five manual pulmonary inflations where each positive pressure inflation will be performed for 5 s at a maximum pressure of 15 cm H2O in the semi-fowler position (30° head-of-bed elevation ). PRM is performed after LS when the main umbilical port is remaining and aims to remove the remaining gas following LS.
Primary Outcome Measure Information:
Title
Postoperative shoulder pain using a Visual Analogue Scale (VAS) based on a 0-10 scale, with 0 meaning no pain and 10 the most intense pain ever experienced
Description
Change in postoperative shoulder pain between the two PRM pressure groups
Time Frame
At postoperative 6, 12 and 24 hours using a visual analogue scale (VAS) based on a 0-10 scale, with 0 meaning no pain and 10 the most intense pain ever experienced.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must be scheduled for LS for benign causes Must be American Society of Anesthesiologists (ASA) class I or II. Exclusion Criteria: Previous lung surgery Preexisting Emphysema Previous Pneumothorax
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gulseren Yilmaz, MD
Organizational Affiliation
Kanuni Sultan Suleyman Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kanuni Sultan Suleyman Training and Research Hospital
City
Istanbul
State/Province
Please Enter The State Or Province
ZIP/Postal Code
34005
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Pulmonary Recruitment Maneuver With 15 and 30 cmH2O Pressure to Reduce the Postoperative Shoulder Pain

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