Decreasing Upper and Shoulder Pain After Laparoscopic Surgery

Taipei Veterans General Hospital

Status and phase: Unknown; Phase 3

Conditions: Nausea; Shoulder Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01433874

100-03-001

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 do is that if the investigators 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

This clinical controlled trial is tried to find out the practical and clinical maneuver to reduce post-operative upper abdominal and shoulder pain after laparoscopic surgery.

Enrollment: 200 estimated patients

Sex: Female

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients receive benign gynecological 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: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 4 patient groups, including a placebo group

Pulmonary recruitment maneuver

Experimental group

Description:

A pulmonary recruitment maneuver consisting five manual pulmonary inflations was performed with a maximum pressure of 60 cmH2O. The anesthesiologist held the fifth positive pressure inflation for approximately 5 seconds.

Treatment:

Procedure: Pulmonary recruitment maneuver

Intraperitoneal normal saline 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 500cc we will leave the fluid in the abdominal cavity.

Treatment:

Procedure: Intraperitoneal normal saline infusion

combined group

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 500cc. Later, a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cmH20. The anesthesiologist held the fifth positive pressure inflation for approximately 5 seconds.

Treatment:

Procedure: combined group

Control group

Placebo Comparator group

Description:

Co2 was removed by passive exsufflation through the port site

Treatment:

Procedure: Control group