Reducing Shoulder Tip Pain Following Laparoscopic Surgery

Taipei Veterans General Hospital

Status and phase: Unknown; Phase 3

Conditions: Laparoscopic Surgery; Shoulder Pain

Treatments: Procedure: Intraperitoneal normal saline; Procedure: Pulmonary recruitment maneuver; Procedure: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT01135836

VGHIRB No. 980705

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: Female

Ages: 20 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 3 patient groups, including a placebo group

pulmonary recruitment maneuver

Experimental group

Description:

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.

Treatment:

Procedure: Pulmonary recruitment maneuver

intraperitoneal normal saline

Experimental group

Description:

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

Treatment:

Procedure: Intraperitoneal normal saline

Control group

Placebo Comparator group

Description:

CO2 was removed by passive exsufflation through the port site.

Treatment:

Procedure: Control group