A Simple Clinical Maneuver to Reduce Laparoscopy Induced Shoulder Pain

Study Overview
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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.

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

Conditions
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Shoulder Pain

Intervention / Treatment
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* Procedure: Recruitment manouver


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>In the control group, CO2 was removed by passive deflation of the abdominal cavity through the holes of the trocar. | |
| Experimental: Intervention<br> | Procedure: Recruitment manouver<br>* In the intervention group, CO2 was removed by means of Trendelenburg position (> 30 degrees) with 5 manual pulmonary recruitment maneuvers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of shoulder pain |  | 48 hours after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Nausea and Vomiting |  | 24hrs after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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