The Effect of Deep Neuromuscular Blockade on Postoperative Shoulder Tip Pain After Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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The purpose of this study was to investigate whether there is any difference in incidence of shoulder tip pain after laparoscopic cholecystectomy between the groups with moderate neuromuscular block and deep neuromuscular block.

Detailed Description
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Laparoscopic cholecystectomy has become the gold standard treatment for gall bladder disease. However, 30-50% of patients suffer from shoulder tip pain, which might arise from diaphragm stretch due to pneumoperitoneum. In the previous pilot study, working intra-abdominal space was increased in the condition of deep neuromuscular blockade. And thus investigators hypothesized that the depth of neuromuscular blockade can affect insufflation pressure and intra-abdominal volume, which result in the severity of diaphragm stretch and postoperative shoulder pain. In addition, the depth of neuromuscular blockade can alter pulmonary compliance.

Official Title
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The Effect of Deep Neuromuscular Blockade on Postoperative Shoulder Tip Pain After Laparoscopic Cholecystectomy

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Rocuronium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: physical status by American society of Anesthesiology; 1 or 2 patients patients with benign gallbladder disease scheduled for laparoscopic cholecystectomy Exclusion Criteria: patient with myasthenia gravis allergy to rocuronium or sugammadex patient with shoulder pain disease (Ex. rotator cuff tear) psychological disease patients who cannot understand Korean

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: moderate NMB + standard pressure<br>Investigators will administrate rocuronium until moderate neuromuscular blockade (Train of Four >=1, Post-tetanic count>=8) is established. And pneumoperitoneum will be maintained with standard-pressure 14 mmHg. | Drug: Rocuronium<br>* We will administrate neuromuscular blocking agent until moderate or deep neuromuscular blockade stabilized.<br>* Other names: Neurpmuscular blockade is provides vy Rocuronium Bromide;|
| Active Comparator: deep NMB + standard pressure<br>Investigators will administrate rocuronium until deep neuromuscular blockade (Train of Four=0, Post-tetanic count<=3) is established. And pneumoperitoneum will be maintained with standard-pressure 14 mmHg. | Drug: Rocuronium<br>* We will administrate neuromuscular blocking agent until moderate or deep neuromuscular blockade stabilized.<br>* Other names: Neurpmuscular blockade is provides vy Rocuronium Bromide;|
| Active Comparator: deep NMB + low pressure<br>Investigators will administrate rocuronium until deep neuromuscular blockade (Train of Four=0, Post-tetanic count<=3) is established. And pneumoperitoneum will be maintained with standard-pressure 8 mmHg. | Drug: Rocuronium<br>* We will administrate neuromuscular blocking agent until moderate or deep neuromuscular blockade stabilized.<br>* Other names: Neurpmuscular blockade is provides vy Rocuronium Bromide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder tip pain | The severity of shoulder tip pain will be measured in PACU and upto postoperative 6, 6-12, 12-24 hours. | upto postoperative 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | The severity and the location of postoperative pain will be measured in PACU and upto postoperative 6, 6-12, 12-24 hours after operation. | upto postoperative 24 hours | 
| Postoperative nausea and vomiting | The severity of nausea, the number of vomiting and the dose and number of administration of rescue antiemetics will be recorded. | upto postoperative 24hours | 
| Intraoperative hemodynamics | Heart rate and blood pressure will be measured at the completion of anesthetic induction, at the completion of carbon dioxide insufflation, at 15 minutes after carbon dioxide insufflation, at the completion of desufflation of pneumoperitoneum, and at the completion of operation. | upto postoperative 24hours | 
| pulmonary compliance | Total lung compliance will be measured by the equation : CT (L/cm H2O) = change in volume/ change in pleural pressure It will be measured at the completion of anesthetic induction, at the completion of carbon dioxide insufflation, at 15 minutes after carbon dioxide insufflation, at the completion of desufflation of pneumoperitoneum, and at the completion of operation | upto postoperative 24 hours | 
| Satisfaction of the surgeon | Satisfaction of the surgeon will be measured by 5-scale numeric rating scale) at the completion of surgery. | upto postoperative 24 hours | 
| Working intrabdominal space | Working intrabdominal space will be measured by grasper (from skin to sacral promontory) at the completion of carbon dioxide insufflation. | upto postoperative 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Postoperative, Neuromuscular Blocking Agents, Laparoscopy