Clinical trial NCT04922359: Effect of Perioperative Lidocaine on Gastrointestinal Function Recovery After Lumbar Spine Surgery in Adults
Official title: Effect of Perioperative Lidocaine on Gastrointestinal Function Recovery After Lumbar Spine Surgery in Adults: a Multicenter, Randomized, Double-blind, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Surgery
Lidocaine
Pain
Opioid Consumption
Gastrointestinal Dysfunction
Keywords: Lidocaine
Gastrointestinal Dysfunction
Spinal surgery
Opioid consumption
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Wangjing Hospital, China Academy of Chinese Medical Sciences
name: First Affiliated Hospital of Guangxi Medical University
First posted: 2021-06-10
Enrollment: 96
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: First anal exhaust time
timeFrame: Day 0
Secondary outcomes:
measure: First defecation time
timeFrame: Day 0
measure: First diet time
timeFrame: Day 0
measure: Time to get out of bed
timeFrame: Day 0
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References: