A Simple Clinical Maneuver to Reduce Laparoscopy Induced Shoulder Pain

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00575237
• Other study ID #: SP230819
• Status: Completed
• Phase: N/A
• First received: December 14, 2007
• Last updated: December 17, 2007
• Start date: February 2004
• Est. completion date: February 2005

Study information

• Verified date: December 2007
• Source: Phelps, Paul, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

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

Locations

Country	Name	City	State
United States	Inland Valley and Rancho Springs Medical Centers	Wildomar	California

Sponsors (2)

Lead Sponsor	Collaborator
Phelps, Paul, M.D.	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of shoulder pain		48 hours after discharge	No
Secondary	Incidence of Nausea and Vomiting		24hrs after discharge	No