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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Rocuronium

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 Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder tip pain	The severity of shoulder tip pain will be measured in PACU and upto postoperative 6, 6-12, 12-24 hours.	upto postoperative 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	upto postoperative 24 hours
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.	upto postoperative 24hours
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.	upto postoperative 24hours
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	upto postoperative 24 hours
Satisfaction of the surgeon	Satisfaction of the surgeon will be measured by 5-scale numeric rating scale) at the completion of surgery.	upto postoperative 24 hours
Working intrabdominal space	Working intrabdominal space will be measured by grasper (from skin to sacral promontory) at the completion of carbon dioxide insufflation.	upto postoperative 24 hours

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Study Director: Yon Hee Shim, MD, PhD, Yonsei University

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: December 12, 2013
• First Submitted That Met QC Criteria: January 13, 2014
• First Posted (Estimate): January 15, 2014

Study Record Updates

• Last Update Posted (Estimate): February 9, 2015
• Last Update Submitted That Met QC Criteria: February 4, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Laparoscopy; Pain, Postoperative; Neuromuscular Blocking Agents
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anticonvulsants; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Bromides; Rocuronium
• Other Study ID Numbers: 3-2013-0210