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Pulmonary Recruitment Maneuver for Postlaparoscopic Shoulder Pain

NCT ID: NCT02596425

Last Updated: 2016-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Gynecologic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Passive deflation

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

Group Type EXPERIMENTAL

Passive deflation

Intervention Type PROCEDURE

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

40 cmH2O

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

Group Type EXPERIMENTAL

40 cmH2O

Intervention Type PROCEDURE

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

60 cmH2O

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

Group Type EXPERIMENTAL

60 cmH2O

Intervention Type PROCEDURE

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

Interventions

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40 cmH2O

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

Intervention Type PROCEDURE

60 cmH2O

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

Intervention Type PROCEDURE

Passive deflation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kangbuk Samsung Hospital

OTHER

Sponsor Role lead

Responsible Party

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Taejong Song

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Taejong Song, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Kangbuk Samsung Hospital

Locations

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Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2015-08-007

Identifier Type: -

Identifier Source: org_study_id