the Effect of Simple Clinical Maneuver on Shoulder and Abdominal Pain a Laparascopic Gynecological Surgery:a Prospective Randomised Trial

September 2, 2018 updated by: Osman Aşıcıoğlu, Istanbul Bakirkoy Maternity and Children Diseases Hospital
The investigators think that a simple maneuver at laparascopic surgery to reduce the postoperative pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

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

  • Turkey
      • Izmir, Turkey, 35120
        • Tepecik Education and Research Hospital

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

15 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. females aged 15-65 years,
  2. American Society of Anesthesiologists (ASA) physical status classification I-III
  3. no previous laparotomy(major abdominal surgery).
  4. need a laparascopic surgery

Exclusion Criteria:

  1. required hospitalization after the laparoscopic surgery,
  2. the procedure required conversion to laparotomy
  3. if a 48-hour follow-up was not feasible

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: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: maneuver group
In the intervention group, CO2 was removed by means of Trendelenburg position (30 degrees) and a pulmonary recruitment maneuver consisting of five manual inflations of the lung.
Behavioral: CO2 was removed by means of trandelenburg positions
No Intervention: clasical group
no additional action will be taken after the operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative 12. hour VAS pain score
Time Frame: 12 hour
12 hour

Secondary Outcome Measures

Outcome Measure
Time Frame
postoperative analgesic requırements
Time Frame: 48 hours
48 hours

Other Outcome Measures

Outcome Measure
Time Frame
postoperative shoulder pain score
Time Frame: 7 days
7 days

Collaborators and Investigators

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

Sponsor

Istanbul Bakirkoy Maternity and Children Diseases Hospital

Investigators

  • Principal Investigator: isa aykut özdemir, m.d., Tepecik Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2013

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

September 7, 2013

First Submitted That Met QC Criteria

September 10, 2013

First Posted (Estimate)

September 11, 2013

Study Record Updates

Last Update Posted (Actual)

September 5, 2018

Last Update Submitted That Met QC Criteria

September 2, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • aşıcıoğlu07

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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