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

Primary Purpose

Rotator Cuff Tears

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lidocaine
Normal saline
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rotator Cuff Tears

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IV lidocaine

Normal saline

Arm Description

Perioperative IV lidocaine infusion

Perioperative IV normal saline infusion

Outcomes

Primary Outcome Measures

Fentanyl requirement using IV PCA
Dose of fentanyl infused via IV PCA machine during first 24 hours after surgery.

Secondary Outcome Measures

Full Information

First Posted
August 12, 2019
Last Updated
August 16, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT04061057
Brief Title
Effect of Perioperative Intravenous Lidocaine Infusion on Postoperative Recovery in Patients Undergoing Arthroscopic Rotator Cuff Repair Under General Anesthesia
Official Title
Effect of Perioperative Intravenous Lidocaine Infusion on Postoperative Recovery in Patients Undergoing Arthroscopic Rotator Cuff Repair Under General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 19, 2018 (Actual)
Primary Completion Date
February 11, 2019 (Actual)
Study Completion Date
February 11, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV lidocaine
Arm Type
Experimental
Arm Description
Perioperative IV lidocaine infusion
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Perioperative IV normal saline infusion
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
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
Intervention Name(s)
Normal saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fentanyl requirement using IV PCA
Description
Dose of fentanyl infused via IV PCA machine during first 24 hours after surgery.
Time Frame
24hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. ASA class 1-3 adults over 19 years scheduled for elective arthroscopic rotator cuff repair Exclusion Criteria: Known allergies to lidocaine or propofol Cardia arrhythmia History of epilepsy or seizures Liver/kidney failure History of recent strong opioid use
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
34636752
Citation
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.
Results Reference
derived

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

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