A Simple Clinical Maneuver to Reduce Laparoscopy Induced Shoulder Pain - Full Text View

Sponsors and Collaborators:	Phelps, Paul, M.D. University of California, San Francisco
Information provided by:	Phelps, Paul, M.D.
ClinicalTrials.gov Identifier:	NCT00575237

Purpose

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

Condition	Intervention
Shoulder Pain	Procedure: Recruitment manouver

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	A Simple Clinical Maneuver to Reduce Laparoscopy Induced Shoulder Pain: A Randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting Surgery

U.S. FDA Resources

Further study details as provided by Phelps, Paul, M.D.:

Primary Outcome Measures:

Intensity of shoulder pain [ Time Frame: 48 hours after discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of Nausea and Vomiting [ Time Frame: 24hrs after discharge ] [ Designated as safety issue: No ]

Enrollment:	100
Study Start Date:	February 2004
Study Completion Date:	February 2005

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

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.

Eligibility

Ages Eligible for Study:	15 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575237

Locations

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

Sponsors and Collaborators

Phelps, Paul, M.D.

University of California, San Francisco

Investigators

Principal Investigator:

Paul Phelps, MD

Department of Anesthesia, Southwest Healthcare System, Murrieta, California

More Information

No publications provided by Phelps, Paul, M.D.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Department of Anesthesia, Southwest Healthcare System, Murrieta, California ( Phelps, Paul, M.D. )
Study ID Numbers:	SP230819
Study First Received:	December 14, 2007
Last Updated:	December 17, 2007
ClinicalTrials.gov Identifier:	NCT00575237 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Phelps, Paul, M.D.:

Laparoscopic Surgery
Shoulder pain
PDNV
Anesthesia

Residual CO2
Postoperative Pain
Female ASA 1 and 2 outpatients who were scheduled for elective gynecologic laparoscopic surgery

Study placed in the following topic categories:

Signs and Symptoms
Musculoskeletal Diseases
Shoulder Pain
Joint Diseases

Anesthetics
Pain
Arthralgia
Pain, Postoperative

Additional relevant MeSH terms:

Signs and Symptoms
Musculoskeletal Diseases
Shoulder Pain

Joint Diseases
Pain
Arthralgia

ClinicalTrials.gov processed this record on September 11, 2009