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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rocuronium
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring Pain, Postoperative, Neuromuscular Blocking Agents, Laparoscopy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Gangnam severance hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

moderate NMB + standard pressure

deep NMB + standard pressure

deep NMB + low pressure

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Shoulder tip pain
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
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
The severity of nausea, the number of vomiting and the dose and number of administration of rescue antiemetics will be recorded.
Intraoperative hemodynamics
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
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
Satisfaction of the surgeon will be measured by 5-scale numeric rating scale) at the completion of surgery.
Working intrabdominal space
Working intrabdominal space will be measured by grasper (from skin to sacral promontory) at the completion of carbon dioxide insufflation.

Full Information

First Posted
December 12, 2013
Last Updated
February 4, 2015
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02036827
Brief Title
The Effect of Deep Neuromuscular Blockade on Postoperative Shoulder Tip Pain After Laparoscopic Cholecystectomy
Official Title
The Effect of Deep Neuromuscular Blockade on Postoperative Shoulder Tip Pain After Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Pain, Postoperative, Neuromuscular Blocking Agents, Laparoscopy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
moderate NMB + standard pressure
Arm Type
Active Comparator
Arm 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.
Arm Title
deep NMB + standard pressure
Arm Type
Active Comparator
Arm 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.
Arm Title
deep NMB + low pressure
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Other Intervention Name(s)
Neurpmuscular blockade is provides vy Rocuronium Bromide
Intervention Description
We will administrate neuromuscular blocking agent until moderate or deep neuromuscular blockade stabilized.
Primary Outcome Measure Information:
Title
Shoulder tip pain
Description
The severity of shoulder tip pain will be measured in PACU and upto postoperative 6, 6-12, 12-24 hours.
Time Frame
upto postoperative 24 hours
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
The severity and the location of postoperative pain will be measured in PACU and upto postoperative 6, 6-12, 12-24 hours after operation.
Time Frame
upto postoperative 24 hours
Title
Postoperative nausea and vomiting
Description
The severity of nausea, the number of vomiting and the dose and number of administration of rescue antiemetics will be recorded.
Time Frame
upto postoperative 24hours
Title
Intraoperative hemodynamics
Description
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.
Time Frame
upto postoperative 24hours
Title
pulmonary compliance
Description
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
Time Frame
upto postoperative 24 hours
Title
Satisfaction of the surgeon
Description
Satisfaction of the surgeon will be measured by 5-scale numeric rating scale) at the completion of surgery.
Time Frame
upto postoperative 24 hours
Title
Working intrabdominal space
Description
Working intrabdominal space will be measured by grasper (from skin to sacral promontory) at the completion of carbon dioxide insufflation.
Time Frame
upto postoperative 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yon Hee Shim, MD, PhD
Organizational Affiliation
Yonsei University
Official's Role
Study Director
Facility Information:
Facility Name
Gangnam severance hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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