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Pulmonary Recruitment Maneuver for Postlaparoscopic Shoulder Pain

Primary Purpose

Gynecologic Diseases

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

40 cmH2O

60 cmH2O

Passive deflation

About this trial

This is an interventional prevention trial for Gynecologic Diseases

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

patients undergoing laparoscopy for benign gynecologic diseases
patients aged 19-65 years
patients with american society of anesthesiology physical status I-II
patients obtaining written informed consent

Exclusion Criteria:

patients with chronic shoulder pain, chronic epigastric pain or chronic pain syndrome
patients with past history of pneumothorax or any pulmonary surgical history
patients with any shoulder surgery histories
patients who required to conversion to open surgery from laparoscopic surgery
patients who required to receive incidental upper abdominal surgeries due to adhesion and injury at upper abdominal cavity
patients with inability to understand or express 10 point visual analogue scale
intrauterine pregnant women

Sites / Locations

Kangbuk Samsung Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Passive deflation

40 cmH2O

60 cmH2O

Arm Description

In the controls, CO2 was removed by the traditional passive deflation of abdominal cavity.

The intervention was five manual inflations of the lungs with positive pressure ventilation of 40 cmH2O at the end of surgery.

The intervention was five manual inflations of the lungs with positive pressure ventilation of 60 cmH2O at the end of surgery.

Outcomes

Primary Outcome Measures

Shoulder pain

The pain score was evaluated by 10 point visual analogue scale.

Secondary Outcome Measures

Wound pain

The pain score was evaluated by 10 point visual analogue scale.

Full Information

NCT ID

NCT02596425

First Posted

November 2, 2015

Last Updated

November 29, 2016

Sponsor

Kangbuk Samsung Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02596425

Brief Title

Pulmonary Recruitment Maneuver for Postlaparoscopic Shoulder Pain

Official Title

Pulmonary Recruitment Maneuver to Reduce Postlaparoscopic Shoulder Pain: Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

November 2015 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kangbuk Samsung Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this clinical trial is to evaluate the efficacy and safety of different recruitment maneuvers for reducing postlaparoscopic shoulder pain.

Detailed Description

Shoulder pain after laparoscopy is common and its probable mechanism is residual CO2 gas after surgery. The pulmonary recruitment maneuver can mechanically remove residual CO2 and reduce pain. In literature, there are two different recruitment maneuvers, which was manual inflation of the lungs with positive pressure ventilation of either 40cmH2O or 60cmH2O at the end of surgery. However, the higher positive pressure may be associated with more chance of barotrauma. Therefore, it is important to determine the lowest effective pressure for reducing postlaparoscopic shoulder pain. The aim of this clinical trial is to evaluate the efficacy and safety of different recruitment maneuvers (40cmH2O or 60cmH2O) for reducing postlaparoscopic shoulder pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gynecologic Diseases

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Passive deflation

Arm Type

Experimental

Arm Description

In the controls, CO2 was removed by the traditional passive deflation of abdominal cavity.

Arm Title

40 cmH2O

Arm Type

Experimental

Arm Description

The intervention was five manual inflations of the lungs with positive pressure ventilation of 40 cmH2O at the end of surgery.

Arm Title

60 cmH2O

Arm Type

Experimental

Arm Description

The intervention was five manual inflations of the lungs with positive pressure ventilation of 60 cmH2O at the end of surgery.

Intervention Type

Procedure

Intervention Name(s)

40 cmH2O

Intervention Description

The intervention was five manual inflations of the lungs with positive pressure ventilation of 40 cmH2O at the end of surgery.

Intervention Type

Procedure

Intervention Name(s)

60 cmH2O

Intervention Description

The intervention was five manual inflations of the lungs with positive pressure ventilation of 60 cmH2O at the end of surgery.

Intervention Type

Procedure

Intervention Name(s)

Passive deflation

Intervention Description

In the controls, CO2 was removed by the traditional passive deflation of abdominal cavity.

Primary Outcome Measure Information:

Title

Shoulder pain

Description

The pain score was evaluated by 10 point visual analogue scale.

Time Frame

after two day of procedure

Secondary Outcome Measure Information:

Title

Wound pain

Description

The pain score was evaluated by 10 point visual analogue scale.

Time Frame

after two day of procedure

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients undergoing laparoscopy for benign gynecologic diseases patients aged 19-65 years patients with american society of anesthesiology physical status I-II patients obtaining written informed consent Exclusion Criteria: patients with chronic shoulder pain, chronic epigastric pain or chronic pain syndrome patients with past history of pneumothorax or any pulmonary surgical history patients with any shoulder surgery histories patients who required to conversion to open surgery from laparoscopic surgery patients who required to receive incidental upper abdominal surgeries due to adhesion and injury at upper abdominal cavity patients with inability to understand or express 10 point visual analogue scale intrauterine pregnant women

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Taejong Song, MD PhD

Organizational Affiliation

Kangbuk Samsung Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kangbuk Samsung Hospital

City

Seoul

ZIP/Postal Code

110-746

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Pulmonary Recruitment Maneuver for Postlaparoscopic Shoulder Pain

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