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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: Phelps, Paul, M.D.

Current Primary Outcome: Intensity of shoulder pain [ Time Frame: 48 hours after discharge ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Incidence of Nausea and Vomiting [ Time Frame: 24hrs after discharge ]

Original Secondary Outcome: Same as current

Information By: Phelps, Paul, M.D.

Dates:
Date Received: December 14, 2007
Date Started: February 2004
Date Completion:
Last Updated: December 17, 2007
Last Verified: December 2007