Randomized Controlled Trail for Post Laparoscopic Pain

Taipei Veterans General Hospital

Status: Unknown

Conditions: Shoulder Pain

Treatments: Procedure: Intraperitoneal infusion; Procedure: Combined maneuver

Study type: Interventional

Funder types: Other

Identifiers

NCT02745574

2013-04-038B

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, we should try to do is that if we could 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.

Full description

All the patients will receive laparoscopic surgery using carbon dioxide (CO2 ) gas as distension medium. At the end of the surgery, in the control group C, CO2 was removed by passive exsufflation through the port site. In the intervention group A, at the end of the surgery, 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. Then, patients will be placed in the Trendelenburg position (30 degrees), and a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cm H2O. The anesthesiologists held the fifth positive pressure inflation for approximately 5 seconds. During these maneuvers, the surgeon was instructed to ensure that the trocar sleeve valve was fully open to allow the CO2 gas to escape.

In the intervention group B, at the end of the surgery, 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.

Patients will be asked to fill out questionnaires up to 48 hours to determine the frequency and severity of their shoulder and upper abdominal pain. The scores will be assessed 12, 24, 48 hours after surgery using a visual analogue scale( VAS) from 0 ( no pain) to 10 ( worst possible pain).

Enrollment: 360 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: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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360 participants in 3 patient groups

Combined maneuver

Experimental group

Description:

Combined maneuver: 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. Then, a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cm dihydrogen monoxide (H2O). The anesthesiologist held the fifth positive pressure inflation for approximately 5 seconds.

Treatment:

Procedure: Combined maneuver

Intraperitoneal infusion

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 infusion

Control group

No Intervention group

Description:

CO2 was removed by passive exsufflation through the port site.