A Simple Clinical Maneuver to Reduce Laparoscopy Induced Shoulder Pain

December 17, 2007 updated by: Phelps, Paul, M.D.

A Simple Clinical Maneuver to Reduce Laparoscopy Induced Shoulder Pain: A Randomized Clinical Trial

A pulmonary recruitment maneuver at the end of surgery reduced shoulder pain as well as nausea and vomiting after laparoscopic surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

With IRB approval and informed consent, 100 female ASA 1 and 2 outpatients who were scheduled for elective gynecologic laparoscopic surgery were randomly allocated to either the current standard (control group) or to additional efforts to remove residual CO2 at the end of surgery (intervention group; power analysis yielded 45 patients necessary per group). In the control group, CO2 was removed by passive deflation of the abdominal cavity through the holes of the trocar. In the intervention group, CO2 was removed by means of Trendelenburg position (> 30 degrees) with 5 manual pulmonary recruitment maneuvers. Postoperative shoulder pain was assessed prior to discharge and 12, 24, 36 and 48 hours later using a visual analog scale (VAS). In addition, positional characteristics of the shoulder pain and incidence of postdischarge nausea and vomiting (PDNV) were recorded 48 hours after surgery.

Study Type

Interventional

Enrollment (Actual)

100

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

  • United States
    • California
      • Wildomar, California, United States, 92595
        • Inland Valley and Rancho Springs Medical Centers

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:

  • female
  • age 15-65
  • ASA I-II
  • scheduled for outpatient gynaecological procedure

Exclusion Criteria:

  • previous laparatomy
  • patients requiring hospitalisation
  • procedure required conversion to laparatomy
  • 48h follow-up no 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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Procedure: Recruitment manouver
In the intervention group, CO2 was removed by means of Trendelenburg position (> 30 degrees) with 5 manual pulmonary recruitment maneuvers.
No Intervention: Control
In the control group, CO2 was removed by passive deflation of the abdominal cavity through the holes of the trocar.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intensity of shoulder pain
Time Frame: 48 hours after discharge
48 hours after discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of Nausea and Vomiting
Time Frame: 24hrs after discharge
24hrs after discharge

Collaborators and Investigators

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

Sponsor

Phelps, Paul, M.D.

Collaborators

University of California, San Francisco

Investigators

  • Principal Investigator: Paul Phelps, MD, Department of Anesthesia, Southwest Healthcare System, Murrieta, California

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

February 1, 2004

Study Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

December 14, 2007

First Submitted That Met QC Criteria

December 17, 2007

First Posted (Estimate)

December 18, 2007

Study Record Updates

Last Update Posted (Estimate)

December 18, 2007

Last Update Submitted That Met QC Criteria

December 17, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP230819

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.

Clinical Trials on Shoulder Pain

Clinical Trials on Recruitment manouver

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe