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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02036827
• Other study ID #: 3-2013-0210
• Status: Completed
• Phase: Phase 4
• First received: December 12, 2013
• Last updated: February 4, 2015
• Start date: December 2013
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Rocuronium
We will administrate neuromuscular blocking agent until moderate or deep neuromuscular blockade stabilized.

Locations

Country	Name	City	State
Korea, Republic of	Gangnam severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No