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

June 2, 2010
June 2, 2010
August 2009
September 2010   (final data collection date for primary outcome measure)
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.

Same as current
No Changes Posted
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.
Same as current
Not Provided
Not Provided
 
Reducing Shoulder Tip Pain Following Laparoscopic Surgery
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

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Shoulder Pain
  • Laparoscopic Surgery
  • 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
  • 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
  • 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 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: Procedure: 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
    Intervention: Procedure: Intraperitoneal normal saline
  • Placebo Comparator: Control group
    CO2 was removed by passive exsufflation through the port site.
    Intervention: Procedure: Control group
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
September 2010
September 2010   (final data collection date for primary outcome measure)

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.
Female
20 Years to 80 Years
No
Contact: Yi-Jen Chen, Ph.D. 886-2-28757566 chenyj@vghtpe.gov.tw
Taiwan
 
NCT01135836
VGHIRB No. 980705
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
Study Chair: Yi-Jen Chen, Ph.D, Taipei Veterans General Hospital, Taiwan
Principal Investigator: Hsiao-Wen Tsai, M.D. Taipei Veterans General Hospital, Taiwan
Taipei Veterans General Hospital, Taiwan
June 2010

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