Effect of Perioperative Lidocaine on Gastrointestinal Function Recovery After Lumbar Spine Surgery in Adults

Effect of Perioperative Lidocaine on Gastrointestinal Function Recovery After Lumbar Spine Surgery in Adults: a Multicenter, Randomized, Double-blind, Controlled Study

Spinal surgery often involves multiple segments. The trauma of surgery is large, the duration of postoperative pain is long, and the pain is severe. Therefore, the use of opioids in perioperative period is large. Although the application of * large amounts of opioids can effectively inhibit pain, it will delay the recovery of urine retention, sedation, respiratory depression and gastrointestinal function. The delayed recovery of gastrointestinal function will increase the postoperative complications, and then increase the length of hospital stay and the cost of patients. Therefore, reducing the dosage of opioids to promote the recovery of gastrointestinal function has become the research direction. Intravenous lidocaine has been proved to be effective in reducing the dosage of opioids during the perioperative period of gastrointestinal surgery and promoting the recovery of postoperative gastrointestinal function. However, there are few studies on the application of lidocaine during the perioperative period of spinal surgery, especially the impact on postoperative gastrointestinal function. In this study, a multicenter, randomized, double-blind, controlled study was conducted to explore the effect of perioperative lidocaine on the recovery of gastrointestinal function after adult lumbar surgery. We hypothesized that lidocaine could shorten the recovery time of gastrointestinal function after lumbar surgery

Study Overview

• Status: Not yet recruiting
• Conditions: Pain; Gastrointestinal Dysfunction; Spinal Surgery; Opioid Consumption; Lidocaine
• Intervention / Treatment: Drug: Lidocain; Drug: normal saline

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jie Gu, attending; Phone Number: 15210886376; Email: hmugujie@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. age 60 to 80;
2. ASA physical status score of I, II or III;
3. Scheduled to undergo a posterior lumbar surgery;
4. Ideal body weight≤80 kg;

Exclusion Criteria:

1. Those who are refused to be included;
2. Those who are allergic to the drugs used in this study;
3. Emergency operation
4. Degree II or III atrioventricular block
5. heart failure
6. History of ALS, preexcitation or active dysrhythmia
7. Severe liver injury (bilirubin > 1.46 mg/dl)
8. Severe renal injury (creatinine clearance < 30 ml/min) or Renal failure
9. History of epilepsy
10. History of porphyria
11. Preoperative hypotension (SBP< 90mmHg)
12. Drug contraindications of NSAIDs
13. Allergic to anaesthetic

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Lidocaine group	Drug: Lidocain; Patients received 1.5mg/kg of intravenous lidocaine during induction of anesthesia and 1.5 mg/kg/h for anesthesia maintenance.
Placebo Comparator: Placebo Comparator: comparator group	Drug: normal saline; Patients received 0.075ml/kg of intravenous normal saline during induction of anesthesia and 0.075ml/kg/h for anesthesia maintenance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First anal exhaust time	Time of first anal exhaust after operation	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First defecation time	Time of first defecation after operation	Day 0
First diet time	Time of first feeding after operation	Day 0
Time to get out of bed	Time to get out of bed after operation	Day 0

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: Wangjing Hospital, China Academy of Chinese Medical Sciences; First Affiliated Hospital of Guangxi Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): October 30, 2022
• Study Completion (Anticipated): May 15, 2023

Study Registration Dates

• First Submitted: June 6, 2021
• First Submitted That Met QC Criteria: June 6, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Actual): June 10, 2021
• Last Update Submitted That Met QC Criteria: June 6, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Lidocaine; Opioid consumption; Spinal surgery; Gastrointestinal Dysfunction
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 2021PHB059-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No