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Completed

NCT Number: NCT00575237

A Simple Clinical Maneuver to Reduce Laparoscopy Induced Shoulder Pain

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

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Key information

Conditions

Shoulder Pain Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

15 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Inland Valley and Rancho Springs Medical Centers

Wildomar, California, 92595, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recruitment manouver

Procedure

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

Primary outcomes

  1. Intensity of shoulder pain

    Time frame: 48 hours after discharge

Secondary outcomes

  1. Incidence of Nausea and Vomiting

    Time frame: 24hrs after discharge

Sponsors and collaborators

Lead sponsor

Phelps, Paul, M.D.

Indiv

Collaborators

  • University of California, San Francisco

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2005
First posted
Dec 18, 2007
Registry last updated
Dec 18, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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