Reducing Shoulder Tip Pain Following Laparoscopic Surgery

Sponsor

Taipei Veterans General Hospital, Taiwan (Other)

Overall Status

Unknown status

CT.gov ID

NCT01135836

Collaborator

National Yang Ming University (Other)

180

Enrollment

Location

Arms

Duration (Months)

13.8

Patients Per Site Per Month

Study Details

Study Description

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 reduce carbon dioxide retention in the pelvic cavity.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Pain Laparoscopic Surgery	Procedure: Pulmonary recruitment maneuver Procedure: Intraperitoneal normal saline 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 should-tip pain following laparoscopic surgery.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

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

Study Start Date :

Aug 1, 2009

Anticipated Primary Completion Date :

Sep 1, 2010

Anticipated Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.
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.
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.

Arm

Intervention/Treatment

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

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.

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.

Outcome Measures

Primary Outcome Measures

the severity and frequency of shoulder-tip pain after laparoscopic surgery [the first 48 hours after the 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.

Secondary Outcome Measures

Nausea or abdominal fullness after laparoscopic surgery [the first 48 hours after the surgery]
Postoperative illness, such as nausea, vomiting or abdominal fullness were also recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Taipei Veterans General Hospital	Taipei		Taiwan	112

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