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

NCT04922359 | Unknown

• 1 other identifier: 2021PHB059-001
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Keywords

Lidocaine; Gastrointestinal Dysfunction; Spinal surgery; Opioid consumption

Outcome Measures

Primary Outcomes (1)

• First anal exhaust time

  Time of first anal exhaust after operation

  Day 0

Secondary Outcomes (3)

• First defecation time

  Day 0

• First diet time

  Day 0

• Time to get out of bed

  Day 0

Study Arms (2)

Experimental: Lidocaine group

EXPERIMENTAL

Drug: Lidocain

Placebo Comparator: comparator group

PLACEBO COMPARATOR

Drug: normal saline

Interventions

Lidocain DRUG

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

Experimental: Lidocaine group

normal saline DRUG

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

Placebo Comparator: comparator group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 60 to 80;
• ASA physical status score of I, II or III;
• Scheduled to undergo a posterior lumbar surgery;
• Ideal body weight≤80 kg;

You may not qualify if:

• Those who are refused to be included;
• Those who are allergic to the drugs used in this study;
• Emergency operation
• Degree II or III atrioventricular block
• heart failure
• History of ALS, preexcitation or active dysrhythmia
• Severe liver injury (bilirubin \> 1.46 mg/dl)
• Severe renal injury (creatinine clearance \< 30 ml/min) or Renal failure
• History of epilepsy
• History of porphyria
• Preoperative hypotension (SBP\< 90mmHg)
• Drug contraindications of NSAIDs
• Allergic to anaesthetic

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Wangjing Hospital, China Academy of Chinese Medical Sciences: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Pain

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Jie Gu, attending

CONTACT

15210886376; hmugujie@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Anesthesiology

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: June 10, 2021
• Study Start: June 1, 2021
• Primary Completion: October 30, 2022
• Study Completion: May 15, 2023
• Last Updated: June 10, 2021

Record last verified: 2021-05

Locations

CN (1)