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A Simple Clinical Maneuver to Reduce Laparoscopy Induced Shoulder Pain

P

Phelps, Paul, M.D.

Status

Completed

Conditions

Shoulder Pain

Treatments

Procedure: Recruitment manouver

Study type

Interventional

Funder types

Other

Identifiers

NCT00575237
SP230819

Details and patient eligibility

About

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

Full 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.

Enrollment

100 patients

Sex

Female

Ages

15 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups

Control
No Intervention group
Description:
In the control group, CO2 was removed by passive deflation of the abdominal cavity through the holes of the trocar.
Intervention
Experimental group
Treatment:
Procedure: Recruitment manouver

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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