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

NCT ID: NCT02036827

Last Updated: 2015-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-01-31

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

moderate NMB + standard pressure

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.

Group Type: ACTIVE_COMPARATOR

Rocuronium

Intervention Type: DRUG

We will administrate neuromuscular blocking agent until moderate or deep neuromuscular blockade stabilized.

deep NMB + standard pressure

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.

Group Type: ACTIVE_COMPARATOR

Rocuronium

Intervention Type: DRUG

We will administrate neuromuscular blocking agent until moderate or deep neuromuscular blockade stabilized.

deep NMB + low pressure

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.

Group Type: ACTIVE_COMPARATOR

Rocuronium

Intervention Type: DRUG

We will administrate neuromuscular blocking agent until moderate or deep neuromuscular blockade stabilized.

Interventions

Rocuronium

We will administrate neuromuscular blocking agent until moderate or deep neuromuscular blockade stabilized.

Intervention Type: DRUG

Other Intervention Names

Neurpmuscular blockade is provides vy Rocuronium Bromide

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Yon Hee Shim

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yon Hee Shim, MD, PhD

Role: STUDY_DIRECTOR

Yonsei University

Locations

Gangnam severance hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

3-2013-0210

Identifier Type: -

Identifier Source: org_study_id