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

P

Peking University

Status

Unknown

Conditions

Spinal Surgery
Gastrointestinal Dysfunction
Opioid Consumption
Lidocaine
Pain

Treatments

Drug: Lidocain
Drug: normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT04922359
2021PHB059-001

Details and patient eligibility

About

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

Enrollment

96 estimated patients

Sex

All

Ages

60 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

96 participants in 2 patient groups, including a placebo group

Experimental: Lidocaine group
Experimental group
Treatment:
Drug: Lidocain
Placebo Comparator: comparator group
Placebo Comparator group
Treatment:
Drug: normal saline

Trial contacts and locations

1

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Central trial contact

Jie Gu, attending

Data sourced from clinicaltrials.gov

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