The Effect of Deep Neuromuscular Blockade on Postoperative Shoulder Tip Pain After Laparoscopic Cholecystectomy
- Registration Number
- NCT02036827
- Lead Sponsor
- Yonsei University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
- physical status by American society of Anesthesiology; 1 or 2 patients
- patients with benign gallbladder disease scheduled for laparoscopic cholecystectomy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description deep NMB + low pressure Rocuronium 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. deep NMB + standard pressure Rocuronium 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. moderate NMB + standard pressure Rocuronium 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.
- Primary Outcome Measures
Name Time Method Shoulder tip pain upto postoperative 24 hours The severity of shoulder tip pain will be measured in PACU and upto postoperative 6, 6-12, 12-24 hours.
- Secondary Outcome Measures
Name Time Method Satisfaction of the surgeon upto postoperative 24 hours Satisfaction of the surgeon will be measured by 5-scale numeric rating scale) at the completion of surgery.
Postoperative nausea and vomiting upto postoperative 24hours The severity of nausea, the number of vomiting and the dose and number of administration of rescue antiemetics will be recorded.
Postoperative pain upto postoperative 24 hours The severity and the location of postoperative pain will be measured in PACU and upto postoperative 6, 6-12, 12-24 hours after operation.
Working intrabdominal space upto postoperative 24 hours Working intrabdominal space will be measured by grasper (from skin to sacral promontory) at the completion of carbon dioxide insufflation.
Intraoperative hemodynamics upto postoperative 24hours 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.
pulmonary compliance upto postoperative 24 hours 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
Trial Locations
- Locations (1)
Gangnam severance hospital
🇰🇷Seoul, Korea, Republic of