Reducing Shoulder Tip Pain Following Laparoscopic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-09-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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Shoulder Pain Laparoscopic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Pulmonary recruitment maneuver

Intervention Type PROCEDURE

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

Group Type EXPERIMENTAL

Intraperitoneal normal saline

Intervention Type PROCEDURE

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.

Group Type PLACEBO_COMPARATOR

Control group

Intervention Type PROCEDURE

CO2 was removed by passive exsufflation through the port site.

Interventions

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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 Type 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.

Intervention Type PROCEDURE

Control group

CO2 was removed by passive exsufflation through the port site.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients receive benign gynaecological laparoscopic surgery.
* American Society of Anesthesiologists (ASA) physical status of patient:

classification I-II