NCT00575237

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 18, 2007

Completed
Last Updated

December 18, 2007

Status Verified

December 1, 2007

First QC Date

December 14, 2007

Last Update Submit

December 17, 2007

Conditions

Shoulder Pain

Keywords

Laparoscopic SurgeryShoulder painPDNVAnesthesiaResidual CO2Postoperative PainFemale ASA 1 and 2 outpatients who were scheduled for elective gynecologic laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

  • Intensity of shoulder pain

    48 hours after discharge

Secondary Outcomes (1)

  • Incidence of Nausea and Vomiting

    24hrs after discharge

Study Arms (2)

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

Interventions

Recruitment manouverPROCEDURE

In the intervention group, CO2 was removed by means of Trendelenburg position (\> 30 degrees) with 5 manual pulmonary recruitment maneuvers.

Intervention

Eligibility Criteria

Age15 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • previous laparatomy
  • patients requiring hospitalisation
  • procedure required conversion to laparatomy
  • h follow-up no feasible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inland Valley and Rancho Springs Medical Centers

Wildomar, California, 92595, United States

Location

Related Publications (1)

  • 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.

    PMID: 18448749DERIVED

MeSH Terms

Conditions

Shoulder PainPain, Postoperative

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Paul Phelps, MD

    Department of Anesthesia, Southwest Healthcare System, Murrieta, California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDIV

Study Record Dates

First Submitted

December 14, 2007

First Posted

December 18, 2007

Study Start

February 1, 2004

Study Completion

February 1, 2005

Last Updated

December 18, 2007

Record last verified: 2007-12

Locations

US(1)