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

NCT ID: NCT04061057

Last Updated: 2019-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-19
• Study Completion Date: 2019-02-11

Brief 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.

Conditions

Rotator Cuff Tears

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

IV lidocaine

Perioperative IV lidocaine infusion

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

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

Perioperative IV normal saline infusion

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Seoul, , South Korea

Countries

South Korea

References

Kim SJ, Choi YS, Chun YM, Kim HJ, Han C, Shin S. Perioperative Intravenous Lidocaine Infusion on Postoperative Recovery in Patients Undergoing Arthroscopic Rotator Cuff Repair Under General Anesthesia: A Randomized Controlled Trial. Clin J Pain. 2021 Oct 12;38(1):1-7. doi: 10.1097/AJP.0000000000000995.

Reference Type: DERIVED

PMID: 34636752 (View on PubMed)

Other Identifiers

4-2018-0033

Identifier Type: -

Identifier Source: org_study_id