Pulmonary Recruitment Maneuver for Postlaparoscopic Shoulder Pain

November 29, 2016 updated by: Taejong Song, Kangbuk Samsung Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Passive deflation
In the controls, CO2 was removed by the traditional passive deflation of abdominal cavity.
Procedure: Passive deflation
In the controls, CO2 was removed by the traditional passive deflation of abdominal cavity.
EXPERIMENTAL: 40 cmH2O
The intervention was five manual inflations of the lungs with positive pressure ventilation of 40 cmH2O at the end of surgery.
Procedure: 40 cmH2O
The intervention was five manual inflations of the lungs with positive pressure ventilation of 40 cmH2O at the end of surgery.
EXPERIMENTAL: 60 cmH2O
The intervention was five manual inflations of the lungs with positive pressure ventilation of 60 cmH2O at the end of surgery.
Procedure: 60 cmH2O
The intervention was five manual inflations of the lungs with positive pressure ventilation of 60 cmH2O at the end of surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder pain
Time Frame: after two day of procedure
The pain score was evaluated by 10 point visual analogue scale.
after two day of procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound pain
Time Frame: after two day of procedure
The pain score was evaluated by 10 point visual analogue scale.
after two day of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kangbuk Samsung Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

November 2, 2015

First Submitted That Met QC Criteria

November 2, 2015

First Posted (ESTIMATE)

November 4, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

December 1, 2016

Last Update Submitted That Met QC Criteria

November 29, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-08-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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