A Simple Clinical Maneuver to Reduce Laparoscopy Induced Shoulder Pain

Overview

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

Full Title of Study: “A Simple Clinical Maneuver to Reduce Laparoscopy Induced Shoulder Pain: A Randomized Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Outcomes Assessor)

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.

Interventions

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

Arms, Groups and Cohorts

  • No Intervention: Control
    • In the control group, CO2 was removed by passive deflation of the abdominal cavity through the holes of the trocar.
  • Experimental: Intervention

Clinical Trial Outcome Measures

Primary Measures

  • Intensity of shoulder pain
    • Time Frame: 48 hours after discharge

Secondary Measures

  • Incidence of Nausea and Vomiting
    • Time Frame: 24hrs after discharge

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 15 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Phelps, Paul, M.D.
  • Collaborator
    • University of California, San Francisco
  • Provider of Information About this Clinical Study
    • Phelps, Paul, M.D., Department of Anesthesia, Southwest Healthcare System, Murrieta, California
  • Overall Official(s)
    • Paul Phelps, MD, Principal Investigator, Department of Anesthesia, Southwest Healthcare System, Murrieta, California

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