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

Not Applicable

• Conditions: Gastrointestinal Dysfunction; Lidocaine; Pain; Opioid Consumption; Spinal Surgery
• Interventions: Drug: normal saline; Drug: Lidocain

• Registration Number: NCT04922359
• Lead Sponsor: Peking University People's Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-05
• Study Start: 2021-06-01
• Study First Submitted: 2021-06-06
• Study First Submitted QC: 2021-06-06
• Last Update Submitted: 2021-06-06
• Study First Posted: 2021-06-10
• Last Update Posted: 2021-06-10
• Primary Completion: 2022-10-30
• Study Completion: 2023-05-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator: comparator group	normal saline	-
Experimental: Lidocaine group	Lidocain	-

Primary Outcome Measures

Name	Time	Method
First anal exhaust time	Day 0	Time of first anal exhaust after operation

Secondary Outcome Measures

Name	Time	Method
First diet time	Day 0	Time of first feeding after operation
First defecation time	Day 0	Time of first defecation after operation
Time to get out of bed	Day 0	Time to get out of bed after operation

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China