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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT02036827

Collaborator

(none)

108

Enrollment

Location

Arms

Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Drug: Rocuronium	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Rocuronium We will administrate neuromuscular blocking agent until moderate or deep neuromuscular blockade stabilized. Other Names: Neurpmuscular blockade is provides vy Rocuronium Bromide
Active Comparator: 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.	Drug: Rocuronium We will administrate neuromuscular blocking agent until moderate or deep neuromuscular blockade stabilized. Other Names: Neurpmuscular blockade is provides vy Rocuronium Bromide
Active Comparator: 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.	Drug: Rocuronium We will administrate neuromuscular blocking agent until moderate or deep neuromuscular blockade stabilized. Other Names: Neurpmuscular blockade is provides vy Rocuronium Bromide

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Rocuronium

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

Other Names:

Neurpmuscular blockade is provides vy Rocuronium Bromide

Active Comparator: 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.

Drug: Rocuronium

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

Other Names:

Neurpmuscular blockade is provides vy Rocuronium Bromide

Active Comparator: deep NMB + low pressure

Drug: Rocuronium

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

Other Names:

Neurpmuscular blockade is provides vy Rocuronium Bromide

Outcome Measures

Primary Outcome Measures

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

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.
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.
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
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

physical status by American society of Anesthesiology; 1 or 2 patients
patients with benign gallbladder disease scheduled for laparoscopic cholecystectomy