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A Simple Clinical Maneuver to Reduce Laparoscopy Induced Shoulder Pain

NCT ID: NCT00575237

Last Updated: 2007-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2005-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Shoulder Pain

Keywords

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Laparoscopic Surgery Shoulder pain PDNV Anesthesia Residual CO2 Postoperative Pain Female ASA 1 and 2 outpatients who were scheduled for elective gynecologic laparoscopic surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control

In the control group, CO2 was removed by passive deflation of the abdominal cavity through the holes of the trocar.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Group Type EXPERIMENTAL

Recruitment manouver

Intervention Type PROCEDURE

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

Interventions

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Recruitment manouver

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role collaborator

Phelps, Paul, M.D.

INDIV

Sponsor Role lead

Responsible Party

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Department of Anesthesia, Southwest Healthcare System, Murrieta, California

Principal Investigators

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Paul Phelps, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia, Southwest Healthcare System, Murrieta, California

Locations

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Inland Valley and Rancho Springs Medical Centers

Wildomar, California, United States

Site Status

Countries

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United States

References

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Phelps P, Cakmakkaya OS, Apfel CC, Radke OC. A simple clinical maneuver to reduce laparoscopy-induced shoulder pain: a randomized controlled trial. Obstet Gynecol. 2008 May;111(5):1155-60. doi: 10.1097/AOG.0b013e31816e34b4.

Reference Type DERIVED
PMID: 18448749 (View on PubMed)

Other Identifiers

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SP230819

Identifier Type: -

Identifier Source: org_study_id