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

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Rocuronium

Study type: Interventional

Funder types: Other

Identifiers

NCT02036827

3-2013-0210

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

108 participants in 3 patient groups

moderate NMB + standard pressure

Active Comparator group

Description:

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.

Treatment:

Drug: Rocuronium

deep NMB + standard pressure

Active Comparator group

Description:

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.

Treatment:

Drug: Rocuronium

deep NMB + low pressure

Active Comparator group

Description:

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.

Treatment:

Drug: Rocuronium