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Decreasing Upper and Shoulder Pain After Laparoscopic Surgery

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ClinicalTrials.gov Identifier: NCT01433874
Recruitment Status : Unknown
Verified July 2011 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was:  Recruiting
First Posted : September 14, 2011
Last Update Posted : September 14, 2011
Sponsor:
Collaborator:
National Yang Ming University
Information provided by:
Taipei Veterans General Hospital, Taiwan

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 do is that if the investigators could reduce carbon dioxide retention in the pelvic cavity.

This clinical controlled trial is tried to find out the practical and clinical maneuver to reduce post-operative should-tip pain following laparoscopic surgery.


Condition or disease Intervention/treatment Phase
Shoulder Pain Nausea Procedure: Pulmonary recruitment maneuver Procedure: Intraperitoneal normal saline infusion Procedure: combined group Procedure: Control group Phase 3

Detailed Description:
This clinical controlled trial is tried to find out the practical and clinical maneuver to reduce post-operative upper abdominal and shoulder pain after laparoscopic surgery.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Maneuvers to Decrease Upper and Shoulder Pain After Gynecologic Laparoscopic Surgery
Study Start Date : February 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: Pulmonary recruitment maneuver
A pulmonary recruitment maneuver consisting five manual pulmonary inflations was performed with a maximum pressure of 60 cmH2O. The anesthesiologist held the fifth positive pressure inflation for approximately 5 seconds.
Procedure: Pulmonary recruitment maneuver
A pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cmH2O. The anesthesiologist held the fifth positive pressure inflation for approximately 5 seconds.
Experimental: Intraperitoneal normal saline infusion
The upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500cc we will leave the fluid in the abdominal cavity.
Procedure: Intraperitoneal normal saline infusion
The upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500cc. We will leave the fluid in the abdominal cavity
Experimental: combined group
The upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500cc. Later, a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cmH20. The anesthesiologist held the fifth positive pressure inflation for approximately 5 seconds.
Procedure: combined group
The upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500cc. Later, a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure oof 60 cmH2O.
Placebo Comparator: Control group
Co2 was removed by passive exsufflation through the port site
Procedure: Control group
Co2 was removed by passive exsufflation through the port site.



Primary Outcome Measures :
  1. The severity and frequency of upper abdominal and shoulder pain after laparoscopic surgery [ Time Frame: The first 48 hours after the surgery ]
    The investigators will follow the patient in the first 48 hours after the surgery. The primary outcome measure of this trial is the severity and frequency of shoulder and upper abdominal pain after laparoscopic surgery.


Secondary Outcome Measures :
  1. nausea or abdominal fullness after laparoscopic surgery [ Time Frame: The first 38 hours after the surgery ]
    postoperative illness, such as nausea, vomiting, or abdominal fullness were also recorded.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients receive benign gynecological 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433874


Contacts
Contact: Yi-Jen Chen, M.D., Ph D. 886-2-2875-7566 chenyj@vghtpe.gov.tw

Locations
Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 112
Contact: Yi-Jen Chen, M.D.,Ph D.    886-2-2875-7566    chenyj@vghtpe.gov.tw   
Principal Investigator: Hsiao-Wen Tsai, M.D.         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
National Yang Ming University
Investigators
Principal Investigator: Hsiao-Wen Tsai, M.D. Taipei Veterans General Hospital, Taiwan
Study Chair: Yi-Jen Chen, M.D., Ph D. Taipei Veterans General Hospital, Taiwan

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yi-Jen, Chen, M.D., Ph D., Department of Obstetrics and Gynecology, Taipei Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01433874     History of Changes
Other Study ID Numbers: 100-03-001
First Posted: September 14, 2011    Key Record Dates
Last Update Posted: September 14, 2011
Last Verified: July 2011

Keywords provided by Taipei Veterans General Hospital, Taiwan:
Shoulder pain
Upper abdominal pain
Laparoscopic surgery
Abdominal fullness

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms