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Reducing Shoulder Tip Pain Following Laparoscopic Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Taipei Veterans General Hospital,Taiwan.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Yang Ming University
Information provided by:
Taipei Veterans General Hospital,Taiwan
ClinicalTrials.gov Identifier:
NCT01135836
First received: June 2, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Shoulder Pain
Laparoscopic Surgery
 Procedure: Pulmonary recruitment maneuver
Procedure: Intraperitoneal normal saline
Procedure: Control group
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Taipei Veterans General Hospital,Taiwan:

Primary Outcome Measures:
  • the severity and frequency of shoulder-tip pain after laparoscopic surgery [ Time Frame: the first 48 hours after the surgery ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: the first 48 hours after the surgery ] [ Designated as safety issue: Yes ]
    Postoperative illness, such as nausea, vomiting or abdominal fullness were also recorded.


Estimated Enrollment: 180
Study Start Date: August 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pulmonary recruitment maneuver
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.
 Procedure: Pulmonary recruitment maneuver
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.
Other Name: Pulmonary recruitment maneuver
Experimental: intraperitoneal normal saline
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
 Procedure: Intraperitoneal normal saline
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.
Other Name: Intraperitoneal normal saline
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.
Other Name: control group

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01135836

Contacts
Contact: Yi-Jen Chen, Ph.D. 886-2-28757566 chenyj@vghtpe.gov.tw

Locations
Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 112
Contact: Yi-Jen Chen, Ph.D.     886-2-28757566     chenyj@vghtpe.gov.tw    
Principal Investigator: Hsiao-Wen Tsai, M.D.            
Sponsors and Collaborators
Taipei Veterans General Hospital,Taiwan
National Yang Ming University
Investigators
Study Chair: Yi-Jen Chen, Ph.D, Taipei Veterans General Hospital,Taiwan
Principal Investigator: Hsiao-Wen Tsai, M.D. Taipei Veterans General Hospital,Taiwan
  More Information

No publications provided by Taipei Veterans General Hospital,Taiwan

Additional 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: NCT01135836     History of Changes
Other Study ID Numbers: VGHIRB No. 980705
Study First Received: June 2, 2010
Last Updated: June 2, 2010
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Taipei Veterans General Hospital,Taiwan:
Shoulder pain
Gynecologic laparoscopic surgery
Nausea
Vomiting
Abdominal fullness

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
 Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013