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
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
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
NCT ID
NCT00575237
First Posted
December 14, 2007
Last Updated
December 17, 2007
Sponsor
Phelps, Paul, M.D.
Collaborators
University of California, San Francisco
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
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