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Decreasing Upper and Shoulder Pain After Laparoscopic Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 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:
NCT01433874
First received: June 14, 2011
Last updated: September 13, 2011
Last verified: July 2011

June 14, 2011
September 13, 2011
February 2011
December 2012   (final data collection date for primary outcome measure)
The severity and frequency of upper abdominal and shoulder pain after laparoscopic surgery [ Time Frame: The first 48 hours after the surgery ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01433874 on ClinicalTrials.gov Archive Site
nausea or abdominal fullness after laparoscopic surgery [ Time Frame: The first 38 hours after the surgery ] [ Designated as safety issue: Yes ]
postoperative illness, such as nausea, vomiting, or abdominal fullness were also recorded.
Same as current
Not Provided
Not Provided
 
Decreasing Upper and Shoulder Pain After Laparoscopic Surgery
Maneuvers to Decrease Upper and Shoulder Pain After Gynecologic Laparoscopic Surgery

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Shoulder Pain
  • Nausea
  • 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.
    Other Name: pulmonary recruitment maneuver
  • 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
    Other Name: intraperitoneal normal saline infusion
  • 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.
    Other Name: combined group
  • Procedure: Control group
    Co2 was removed by passive exsufflation through the port site.
    Other Name: control group
  • 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.
    Intervention: Procedure: Pulmonary recruitment maneuver
  • 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.
    Intervention: Procedure: Intraperitoneal normal saline infusion
  • 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.
    Intervention: Procedure: combined group
  • Placebo Comparator: Control group
    Co2 was removed by passive exsufflation through the port site
    Intervention: Procedure: Control group

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Female
20 Years to 80 Years
No
Contact: Yi-Jen Chen, M.D., Ph D. 886-2-2875-7566 chenyj@vghtpe.gov.tw
Taiwan
 
NCT01433874
100-03-001
Yes
Yi-Jen, Chen, M.D., Ph D., Department of Obstetrics and Gynecology, Taipei Veterans General Hospital
Taipei Veterans General Hospital, Taiwan
National Yang Ming University
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
Taipei Veterans General Hospital, Taiwan
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP