Spinal SurgeryNCT04922359
Effect of Perioperative Lidocaine on Gastrointestinal Function Recovery After Lumbar Spine Surgery in Adults
A study testing Lidocain and normal saline in people with Spinal Surgery and Lidocaine, run by Peking University People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Spinal Surgery, Lidocaine, Pain
- What is being tested?
- Lidocain and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 15 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: Effect of Perioperative Lidocaine on Gastrointestinal Function Recovery After Lumbar Spine Surgery in Adults: a Multicenter, Randomized, Double-blind, Controlled Study
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
- Being tested
- Lidocain, normal saline
- Keywords
- Lidocaine, Gastrointestinal Dysfunction, Spinal surgery, Opioid consumption
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocainDrug
Patients received 1.5mg/kg of intravenous lidocaine during induction of anesthesia and 1.5 mg/kg/h for anesthesia maintenance.
normal salineDrug
Patients received 0.075ml/kg of intravenous normal saline during induction of anesthesia and 0.075ml/kg/h for anesthesia maintenance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Lidocaine group | Experimental | Not described Receives: Drug: Lidocain |
| Placebo Comparator: comparator group | Placebo comparator | Not described Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
First anal exhaust time
Time of first anal exhaust after operation
Measured: Day 0
Secondary outcomes (3)
First defecation time
Time of first defecation after operation
Measured: Day 0
First diet time
Time of first feeding after operation
Measured: Day 0
Time to get out of bed
Time to get out of bed after operation
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 Jun 2021 (estimated)
- Primary completion30 Oct 2022 (estimated)
- Study completion15 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal SurgeryStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wangjing Hospital, China Academy of Chinese Medical Sciences, First Affiliated Hospital of Guangxi Medical University
- Responsible party
- Principal investigator, Yi Feng, MD, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922359
- Sponsor's protocol ID
- 2021PHB059-001
- Status last verified
- May 2021
- First submitted
- 6 Jun 2021
- Last updated
- 10 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Lidocaine on Gastrointestinal Function Recovery After Lumbar Spine Surgery in Adults: a Multicenter, Randomized, Double-blind, Controlled Study
- ClinicalTrials.gov ID
- NCT04922359
- Acronym / sponsor ID
- 2021PHB059-001
- Keywords
- Lidocaine, Gastrointestinal Dysfunction, Spinal surgery, Opioid consumption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Wangjing Hospital, China Academy of Chinese Medical Sciences, First Affiliated Hospital of Guangxi Medical University
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 15 May 2023 (estimated)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Lidocaine group | Experimental | Drug: Lidocain |
| Placebo Comparator: comparator group | Placebo comparator | Drug: normal saline |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocainPatients received 1.5mg/kg of intravenous lidocaine during induction of anesthesia and 1.5 mg/kg/h for anesthesia maintenance. | Drug | Experimental: Lidocaine group |
| normal salinePatients received 0.075ml/kg of intravenous normal saline during induction of anesthesia and 0.075ml/kg/h for anesthesia maintenance. | Drug | Placebo Comparator: comparator group |
Primary outcome
First anal exhaust time
Time frame: Day 0
Time of first anal exhaust after operation
3 secondary outcomes
First defecation time
Time frame: Day 0
First diet time
Time frame: Day 0
Time to get out of bed
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocain and normal saline in people with Spinal Surgery and Lidocaine, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Gu, attending (15210886376, hmugujie@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First anal exhaust time (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.