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

NCT ID: NCT04922359

Last Updated: 2021-06-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2023-05-15

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

Conditions

Spinal Surgery; Lidocaine; Pain; Opioid Consumption; Gastrointestinal Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Experimental: Lidocaine group

Group Type: EXPERIMENTAL

Lidocain

Intervention Type: DRUG

Patients received 1.5mg/kg of intravenous lidocaine during induction of anesthesia and 1.5 mg/kg/h for anesthesia maintenance.

Placebo Comparator: comparator group

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

Patients received 0.075ml/kg of intravenous normal saline during induction of anesthesia and 0.075ml/kg/h for anesthesia maintenance.

Interventions

Lidocain

Patients received 1.5mg/kg of intravenous lidocaine during induction of anesthesia and 1.5 mg/kg/h for anesthesia maintenance.

Intervention Type: DRUG

normal saline

Patients received 0.075ml/kg of intravenous normal saline during induction of anesthesia and 0.075ml/kg/h for anesthesia maintenance.

Intervention Type: DRUG

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wangjing Hospital, China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Guangxi Medical University

OTHER

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yi Feng, MD

Head of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Jie Gu, attending

Role: CONTACT

hmugujie@163.com

15210886376

Other Identifiers

2021PHB059-001

Identifier Type: -

Identifier Source: org_study_id