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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: October 30, 2022

Interventions

  • Drug: Lidocain
    • Patients received 1.5mg/kg of intravenous lidocaine during induction of anesthesia and 1.5 mg/kg/h for anesthesia maintenance.
  • Drug: normal saline
    • Patients received 0.075ml/kg of intravenous normal saline during induction of anesthesia and 0.075ml/kg/h for anesthesia maintenance.

Arms, Groups and Cohorts

  • Experimental: Experimental: Lidocaine group
  • Placebo Comparator: Placebo Comparator: comparator group

Clinical Trial Outcome Measures

Primary Measures

  • First anal exhaust time
    • Time Frame: Day 0
    • Time of first anal exhaust after operation

Secondary Measures

  • First defecation time
    • Time Frame: Day 0
    • Time of first defecation after operation
  • First diet time
    • Time Frame: Day 0
    • Time of first feeding after operation
  • Time to get out of bed
    • Time Frame: Day 0
    • Time to get out of bed after operation

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Peking University People’s Hospital
  • Collaborator
    • Wangjing Hospital, China Academy of Chinese Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yi Feng, MD, Head of Anesthesiology – Peking University People’s Hospital
  • Overall Contact(s)
    • Jie Gu, attending, 15210886376, hmugujie@163.com

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