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A Simple Clinical Maneuver to Reduce Laparoscopy Induced Shoulder Pain

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00575237
Enrollment
100
Registered
2007-12-18
Start date
2004-02-29
Completion date
2005-02-28
Last updated
2007-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Pain

Keywords

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

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.

Interventions

PROCEDURERecruitment manouver

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

Sponsors

University of California, San Francisco
CollaboratorOTHER
Phelps, Paul, M.D.
Lead SponsorINDIV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Intensity of shoulder pain48 hours after discharge

Secondary

MeasureTime frame
Incidence of Nausea and Vomiting24hrs after discharge

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026