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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04922359
• Other study ID #: 2021PHB059-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: May 15, 2023

Study information

• Verified date: May 2021
• Source: Peking University People's Hospital
• Contact: Jie Gu, attending
• Phone: 15210886376
• Email: hmugujie[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: May 15, 2023
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking University People's Hospital	First Affiliated Hospital of Guangxi Medical University, Wangjing Hospital, China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First anal exhaust time	Time of first anal exhaust after operation	Day 0
Secondary	First defecation time	Time of first defecation after operation	Day 0
Secondary	First diet time	Time of first feeding after operation	Day 0
Secondary	Time to get out of bed	Time to get out of bed after operation	Day 0