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

Study Overview
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Brief Summary
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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

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

Conditions
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Pain, Spinal Surgery, Lidocaine, Opioid Consumption, Gastrointestinal Dysfunction

Intervention / Treatment
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* Drug: Lidocain
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 60 to 80; ASA physical status score of I, II or III; Scheduled to undergo a posterior lumbar surgery; Ideal body weight≤80 kg; Exclusion Criteria: Those who are refused to be included; Those who are allergic to the drugs used in this study; Emergency operation Degree II or III atrioventricular block heart failure History of ALS, preexcitation or active dysrhythmia Severe liver injury (bilirubin > 1.46 mg/dl) Severe renal injury (creatinine clearance < 30 ml/min) or Renal failure History of epilepsy History of porphyria Preoperative hypotension (SBP< 90mmHg) Drug contraindications of NSAIDs Allergic to anaesthetic

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lidocaine, Gastrointestinal Dysfunction, Spinal surgery, Opioid consumption