Reducing Shoulder Tip Pain Following Laparoscopic Surgery

Shoulder Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01135836
• Other study ID #: VGHIRB No. 980705
• Status: Recruiting
• Phase: Phase 3
• First received: June 2, 2010
• Last updated: June 2, 2010
• Start date: August 2009
• Est. completion date: September 2010

Study information

• Verified date: June 2010
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Yi-Jen Chen, Ph.D.
• Phone: 886-2-28757566
• Email: chenyj[@]vghtpe.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Laparoscopic Surgery
• Shoulder Pain

Intervention

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.
• 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.
• Control group
CO2 was removed by passive exsufflation through the port site.

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan	National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	the first 48 hours after the surgery	Yes
Secondary	Nausea or abdominal fullness after laparoscopic surgery	Postoperative illness, such as nausea, vomiting or abdominal fullness were also recorded.	the first 48 hours after the surgery	Yes