A Simple Clinical Maneuver to Reduce Laparoscopy Induced Shoulder Pain

Not Applicable

Completed

• Conditions: Shoulder Pain
• Interventions: Procedure: Recruitment manouver

• Registration Number: NCT00575237
• Lead Sponsor: Phelps, Paul, M.D.

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.

Study Timeline

• Study Start: 2004-02
• Study Completion: 2005-02
• Status Verified: 2007-12
• Study First Submitted: 2007-12-14
• Study First Submitted QC: 2007-12-17
• Last Update Submitted: 2007-12-17
• Study First Posted: 2007-12-18
• Last Update Posted: 2007-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Recruitment manouver	-

Primary Outcome Measures

Name	Time	Method
Intensity of shoulder pain	48 hours after discharge

Secondary Outcome Measures

Name	Time	Method
Incidence of Nausea and Vomiting	24hrs after discharge

Trial Locations

Locations (1)

Inland Valley and Rancho Springs Medical Centers; 🇺🇸 Wildomar, California, United States