search
Back to results

A Simple Clinical Maneuver to Reduce Laparoscopy Induced Shoulder Pain

Primary Purpose

Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Recruitment manouver
Sponsored by
Phelps, Paul, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Shoulder Pain focused on measuring Laparoscopic Surgery, Shoulder pain, PDNV, Anesthesia, Residual CO2, Postoperative Pain, Female ASA 1 and 2 outpatients who were scheduled for elective gynecologic laparoscopic surgery

Eligibility Criteria

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

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

Sites / Locations

  • Inland Valley and Rancho Springs Medical Centers

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

In the control group, CO2 was removed by passive deflation of the abdominal cavity through the holes of the trocar.

Outcomes

Primary Outcome Measures

Intensity of shoulder pain

Secondary Outcome Measures

Incidence of Nausea and Vomiting

Full Information

First Posted
December 14, 2007
Last Updated
December 17, 2007
Sponsor
Phelps, Paul, M.D.
Collaborators
University of California, San Francisco
search

1. Study Identification

Unique Protocol Identification Number
NCT00575237
Brief Title
A Simple Clinical Maneuver to Reduce Laparoscopy Induced Shoulder Pain
Official Title
A Simple Clinical Maneuver to Reduce Laparoscopy Induced Shoulder Pain: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Phelps, Paul, M.D.
Collaborators
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
Laparoscopic Surgery, Shoulder pain, PDNV, Anesthesia, Residual CO2, Postoperative Pain, Female ASA 1 and 2 outpatients who were scheduled for elective gynecologic laparoscopic surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
In the control group, CO2 was removed by passive deflation of the abdominal cavity through the holes of the trocar.
Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Recruitment manouver
Intervention Description
In the intervention group, CO2 was removed by means of Trendelenburg position (> 30 degrees) with 5 manual pulmonary recruitment maneuvers.
Primary Outcome Measure Information:
Title
Intensity of shoulder pain
Time Frame
48 hours after discharge
Secondary Outcome Measure Information:
Title
Incidence of Nausea and Vomiting
Time Frame
24hrs after discharge

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Phelps, MD
Organizational Affiliation
Department of Anesthesia, Southwest Healthcare System, Murrieta, California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inland Valley and Rancho Springs Medical Centers
City
Wildomar
State/Province
California
ZIP/Postal Code
92595
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18448749
Citation
Phelps P, Cakmakkaya OS, Apfel CC, Radke OC. A simple clinical maneuver to reduce laparoscopy-induced shoulder pain: a randomized controlled trial. Obstet Gynecol. 2008 May;111(5):1155-60. doi: 10.1097/AOG.0b013e31816e34b4.
Results Reference
derived

Learn more about this trial

A Simple Clinical Maneuver to Reduce Laparoscopy Induced Shoulder Pain

We'll reach out to this number within 24 hrs