The Effect of Deep Neuromuscular Blockade on Postoperative Shoulder Tip Pain After Laparoscopic Cholecystectomy
Information source: Yonsei University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain, Postoperative
Intervention: Rocuronium (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Yonsei University Official(s) and/or principal investigator(s):
Yon Hee Shim, MD, PhD, Study Director, Affiliation: Yonsei University
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.
Clinical Details
Official title: The Effect of Deep Neuromuscular Blockade on Postoperative Shoulder Tip Pain After Laparoscopic Cholecystectomy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Shoulder tip pain
Secondary outcome: Postoperative painPostoperative nausea and vomiting Intraoperative hemodynamics pulmonary compliance Satisfaction of the surgeon Working intrabdominal space
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.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Gangnam severance hospital, Seoul, Korea, Republic of
Additional Information
Starting date: December 2013
Last updated: February 4, 2015
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