Decreasing Upper and Shoulder Pain After Laparoscopic Surgery

Study Overview
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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 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.

Detailed Description
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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.

Official Title
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Maneuvers to Decrease Upper and Shoulder Pain After Gynecologic Laparoscopic Surgery

Conditions
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Shoulder Pain, Nausea

Intervention / Treatment
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* Procedure: Pulmonary recruitment maneuver
* Procedure: Intraperitoneal normal saline infusion
* Procedure: combined group
* Procedure: Control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulmonary recruitment maneuver<br>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. | Procedure: Pulmonary recruitment maneuver<br>* A pulmonary recruitment maneuver consisting of 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.<br>|
| Experimental: Intraperitoneal normal saline infusion<br>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. | Procedure: Intraperitoneal normal saline infusion<br>* 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<br>|
| Experimental: combined group<br>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. | Procedure: combined group<br>* 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 oof 60 cmH2O.<br>|
| Placebo Comparator: Control group<br>Co2 was removed by passive exsufflation through the port site | Procedure: Control group<br>* Co2 was removed by passive exsufflation through the port site.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The severity and frequency of upper abdominal and shoulder pain after laparoscopic surgery | The investigators will follow the patient in the first 48 hours after the surgery. The primary outcome measure of this trial is the severity and frequency of shoulder and upper abdominal pain after laparoscopic surgery. | The first 48 hours after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nausea or abdominal fullness after laparoscopic surgery | postoperative illness, such as nausea, vomiting, or abdominal fullness were also recorded. | The first 38 hours after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder pain, Upper abdominal pain, Laparoscopic surgery, Abdominal fullness