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Reducing Shoulder Tip Pain Following Laparoscopic Surgery

Primary Purpose

Shoulder Pain, Laparoscopic Surgery

Status
Unknown status
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Pulmonary recruitment maneuver
Intraperitoneal normal saline
Control group
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Shoulder Pain focused on measuring Shoulder pain, Gynecologic laparoscopic surgery, Nausea, Vomiting, Abdominal fullness

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients receive benign gynaecological laparoscopic surgery.
  • American Society of Anesthesiologists (ASA) physical status of patient:

classification I-II

Exclusion Criteria:

  • The procedure will be required to conversion to laparotomy.
  • Any cardio-vascular diseases.

Sites / Locations

  • Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

pulmonary recruitment maneuver

intraperitoneal normal saline

Control group

Arm Description

a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cm H2O. The anestheiologist held the fifth positive pressure inflation for approximately 5 seconds.

the upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500 cc. We will leave the fluid in the abdominal cavity

CO2 was removed by passive exsufflation through the port site.

Outcomes

Primary Outcome Measures

the severity and frequency of shoulder-tip pain after laparoscopic surgery
We will follow the patients in the first 48 hours after the surgery. The primary outcome measure of this trial is the severity and frequency of shoulder-tip pain after laparoscopic surgery. The main objective of this trial is to assess the efficacy of clinical maneuver to reduce shoulder-tip pain after laparoscopic surgery.

Secondary Outcome Measures

Nausea or abdominal fullness after laparoscopic surgery
Postoperative illness, such as nausea, vomiting or abdominal fullness were also recorded.

Full Information

First Posted
June 2, 2010
Last Updated
June 2, 2010
Sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT01135836
Brief Title
Reducing Shoulder Tip Pain Following Laparoscopic Surgery
Official Title
A Randomized, Controlled, Single Blind Study Comparing a Pulmonary Recruitment Maneuver Versus Intraperitoneal Infusion of Normal Saline to Reduce Shoulder Tip Pain After Gynecologic Laparoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
September 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
National Yang Ming University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Laparoscopic surgery is becoming a major procedure, owing to smaller incisions, shorter hospitalizations, and less post-operative pain as compared with traditional laparotomies. However, there is marked interindividual variability of post-operative shoulder-tip pain following laparoscopic surgery. The incidence of shoulder pain varies from 35% to 80% and ranges from mild to severe. In some cases, it has been reported to last more than 72 hours after surgery. The hypothesis of post-operative shoulder-tip pain is that carbon dioxide induced phrenic nerve irritation causes referred pain to C4. Therefore, the investigators should try to reduce carbon dioxide retention in the pelvic cavity.
Detailed Description
This clinical controlled trial is tried to find out the practical and clinical maneuver to reduce post-operative should-tip pain following laparoscopic surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Laparoscopic Surgery
Keywords
Shoulder pain, Gynecologic laparoscopic surgery, Nausea, Vomiting, Abdominal fullness

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pulmonary recruitment maneuver
Arm Type
Experimental
Arm Description
a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cm H2O. The anestheiologist held the fifth positive pressure inflation for approximately 5 seconds.
Arm Title
intraperitoneal normal saline
Arm Type
Experimental
Arm Description
the upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500 cc. We will leave the fluid in the abdominal cavity
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
CO2 was removed by passive exsufflation through the port site.
Intervention Type
Procedure
Intervention Name(s)
Pulmonary recruitment maneuver
Intervention Description
a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cm H2O. The anestheiologist held the fifth positive pressure inflation for approximately 5 seconds.
Intervention Type
Procedure
Intervention Name(s)
Intraperitoneal normal saline
Intervention Description
the upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500 cc. We will leave the fluid in the abdominal cavity.
Intervention Type
Procedure
Intervention Name(s)
Control group
Intervention Description
CO2 was removed by passive exsufflation through the port site.
Primary Outcome Measure Information:
Title
the severity and frequency of shoulder-tip pain after laparoscopic surgery
Description
We will follow the patients in the first 48 hours after the surgery. The primary outcome measure of this trial is the severity and frequency of shoulder-tip pain after laparoscopic surgery. The main objective of this trial is to assess the efficacy of clinical maneuver to reduce shoulder-tip pain after laparoscopic surgery.
Time Frame
the first 48 hours after the surgery
Secondary Outcome Measure Information:
Title
Nausea or abdominal fullness after laparoscopic surgery
Description
Postoperative illness, such as nausea, vomiting or abdominal fullness were also recorded.
Time Frame
the first 48 hours after the surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients receive benign gynaecological laparoscopic surgery. American Society of Anesthesiologists (ASA) physical status of patient: classification I-II Exclusion Criteria: The procedure will be required to conversion to laparotomy. Any cardio-vascular diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Jen Chen, Ph.D.
Phone
886-2-28757566
Email
chenyj@vghtpe.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Jen Chen, Ph.D,
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hsiao-Wen Tsai, M.D.
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-Jen Chen, Ph.D.
Phone
886-2-28757566
Email
chenyj@vghtpe.gov.tw
First Name & Middle Initial & Last Name & Degree
Hsiao-Wen Tsai, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
22184293
Citation
Tsai HW, Chen YJ, Ho CM, Hseu SS, Chao KC, Tsai SK, Wang PH. Maneuvers to decrease laparoscopy-induced shoulder and upper abdominal pain: a randomized controlled study. Arch Surg. 2011 Dec;146(12):1360-6. doi: 10.1001/archsurg.2011.597.
Results Reference
derived

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Reducing Shoulder Tip Pain Following Laparoscopic Surgery

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