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Clinical Trials/NCT00575237
NCT00575237
Completed
Not Applicable

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

Phelps, Paul, M.D.1 site in 1 country100 target enrollmentFebruary 2004
ConditionsShoulder Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Shoulder Pain
Sponsor
Phelps, Paul, M.D.
Enrollment
100
Locations
1
Primary Endpoint
Intensity of shoulder pain
Status
Completed
Last Updated
18 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2004
End Date
February 2005
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Phelps, Paul, M.D.

Eligibility Criteria

Inclusion Criteria

  • age 15-65
  • scheduled for outpatient gynaecological procedure

Exclusion Criteria

  • previous laparatomy
  • patients requiring hospitalisation
  • procedure required conversion to laparatomy
  • 48h follow-up no feasible

Outcomes

Primary Outcomes

Intensity of shoulder pain

Time Frame: 48 hours after discharge

Secondary Outcomes

  • Incidence of Nausea and Vomiting(24hrs after discharge)

Study Sites (1)

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