Effect of Perioperative Intravenous Lidocaine Infusion on Postoperative Recovery in Patients Undergoing Arthroscopic Rotator Cuff Repair Under General Anesthesia

Rotator Cuff Tears Clinical Trial

Official title:

Effect of Perioperative Intravenous Lidocaine Infusion on Postoperative Recovery in Patients Undergoing Arthroscopic Rotator Cuff Repair Under General Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04061057
• Other study ID #: 4-2018-0033
• Status: Completed
• Phase: N/A
• Start date: March 19, 2018
• Est. completion date: February 11, 2019

Study information

• Verified date: August 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Arthroscopic rotator cuff repair is a commonly performed procedure but is known to cause significant postoperative pain. Effective analgesia after rotator cuff repair is crucial in improving the well-being of the patient but also to ensure long-term rehabilitation. The most commonly used analgesic for acute postoperative pain is opioids. However, the use of opioids is accompanied by several side effects which include but are not limited to nausea/vomiting, urinary retention, itching sensation and sometimes dizziness, respiratory depression and hypotension in higher doses. As of late, many efforts are aimed toward decreasing the use of opioids by using multimodal analgesia. Among such methods, intravenous lidocaine has been reported to be effective, safe and economic in various procedures. However, the existing evidence is mostly focused on laparoscopic procedures. The present study aims to find whether perioperative infusion of lidocaine is able to decrease opioid requirements after surgery and also improve postoperative pain compared to placebo in patients undergoing arthroscopic rotator cuff repair.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: February 11, 2019
• Est. primary completion date: February 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. ASA class 1-3 adults over 19 years scheduled for elective arthroscopic rotator cuff repair

Exclusion Criteria:

1. Known allergies to lidocaine or propofol

2. Cardia arrhythmia

3. History of epilepsy or seizures

4. Liver/kidney failure

5. History of recent strong opioid use

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Drug:
• Lidocaine
Drug: 1. Lidocaine Intravenous lidocaine bolus of 1.5mg/kg immediately after anesthesia induction followed by infusion at 2.0mg/kg/hr up to 1 hr after end of surgery. 2. Fentanyl IV infusion via PCA (patient controlled analgesia) machine of fentanyl 10 µg/ml, ramosetron 0.3 mg, normal saline, total 100 ml, infusion rate 1 ml/hr, 1 ml bolus and lockout time 7 min.
• Normal saline
Drug: 1. Normal saline Intravenous normal saline bolus of immediately after anesthesia induction followed by infusion up to 1 hr after end of surgery. Volume of normal saline is equal to lidocaine. 2. Fentanyl IV infusion via PCA (patient controlled analgesia) machine of fentanyl 10 µg/ml, ramosetron 0.3 mg, normal saline, total 100 ml, infusion rate 1 ml/hr, 1 ml bolus and lockout time 7 min.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine	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	Fentanyl requirement using IV PCA	Dose of fentanyl infused via IV PCA machine during first 24 hours after surgery.	24hours after surgery