SurgeryPhase 4NCT04043624
The Study of Perioperative Intravenous Infusion of Lidocaine on Postoperative Analgesia in Patients Undergoing Single-port Thoracoscopic
A Phase 4 study testing Lidocaine and Saline in people with Surgery, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effect of intravenous lidocaine infusion on pain and opioid dosage in patients undergoing single-port thoracoscopic surgery,and to evaluate the effects of perioperative catecholamine levels, extubation time, incidence of nausea and vomiting, patient satisfaction and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Surgery
- What is being tested?
- Lidocaine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 31 Dec 2020
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing single-port thoracoscopic with a left double lumen bronchial catheter
- Age ≧ 18 years old, ≦70 years old
- Temperature, white blood cells, and hemoglobin were normal before surgery
- Patient informed consent
Who cannot join
- Patients with a history of surgery within six months
- Patients with dysfunction of heart, liver, kidney, lung, pancreas or other important organs
- American Society of Anesthesiologists (ASA) physical Status classes ≧ Ⅲ
- Allergic to lidocaine
- Bradycardia (heart rate < 60 beats/min) or atrioventricular block
- Mental disorder
- Patients requiring a right double lumen bronchial catheter
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Jin Ma, 86+18867539602, 1241370980@qq.com
About this study
The purpose of this study is to evaluate the effect of intravenous lidocaine infusion on pain and opioid dosage in patients undergoing single-port thoracoscopic surgery,and to evaluate the effects of perioperative catecholamine levels, extubation time, incidence of nausea and vomiting, patient satisfaction and hospital stay.
Read the detailed description
The World Congress on Pain identified pain as the "fifth leading indicator of human life" after breathing, pulse, body temperature and blood pressure. Postoperative pain is an acute nociceptive pain caused by surgical trauma and is a complex stress response in the body, especially in 72 hours after surgery. Pain after thoracic surgery is a more severe type of surgery in various types of surgery.
Acute pain at the early stage of operation is not only an external signal of body injury, but also an independent factor inducing stress response and systemic inflammatory response syndrome (SIRS). Pain stimulus can also cause excessive release of catecholamine, damage of vascular endothelial cells and neutrophil aggregation, which can induce cytokine "waterfall" secretion. Stress, pain and inflammation induce and interact with each other, which seriously affects the early recovery of patients after operation. Timely and effective post-operative analgesia can not only alleviate patients'pain, but also avoid a series of stress reactions. It provides favorable conditions for the stability of patients' physiological function and recovery of their body after operation.
Although multimodal analgesia has largely replaced monotherapy with opioids, they are still the most commonly used drugs for postoperative pain. Lidocaine is an amide local anesthetic which when used intravenously demonstrates significant analgesic, anti-hyperalgesic and anti-inflammatory properties .
Intravenous infusion of lidocaine has a good effect on fibromyalgia, chronic neuropathic pain, opioid tolerance and other chronic pain, and can reduce postoperative acute pain. In the 1960s, Barlett et al. first published a study on the use of lidocaine intravenous infusion for postoperative analgesia.Since then, more and more researchers have begun to explore the use of lidocaine in the treatment of postoperative acute pain.In 2007, Kaba et al. selected patients who underwent colectomy as an experimental subject, and intravenously injected lidocaine during the perioperative period. The results showed that the pain of the experimental group was effectively relieved and the use of opioids was reduced. In 2008, Lauwick et al. used laparoscopic cholecystectomy as the experimental subject. The results showed that the dose of opioid analgesia in the lidocaine group was significantly lower than that in the control group, and the postoperative pain was effectively improved. In 2009, Yardeni et al. selected patients undergoing total hysterectomy as experimental subjects and intravenously injected lidocaine during the perioperative period. The results confirmed that the hemodynamics of the experimental group was more stable, the average dosage of anesthetics was reduced, and the pain was significantly improved.However, to date, there is no strong evidence for the effect of perioperative intravenous infusion of lidocaine in single-port thoracoscopic surgery, so we designed this study.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
regimen of lidocaine administration of 1.5 mg/kg, IV bolus, followed by continuous infusion at 2 mg/kg/h
SalineDrug
IV bolus of saline, followed by continuous infusion of saline
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine group | Experimental | First group (lidocaine group) will include those who receive a intraoperative lidocaine infusion.Induction bolus dose of 1.5 mg/kg body weight ( 30 minutes before incision)followed by a continous lidocaine infusion of 2mg/kg/h，until 1 hours after skin closure. Receives: Drug: Lidocaine |
| Saline group | Placebo comparator | The second group（saline group） will include those who receive a intraoperative placebo.The same dosage of saline was given according to the same method of administration in the lidocaine group. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score
Using Visual Analogue Scales
Measured: Immediately postoperation
Postoperative pain score
Using Visual Analogue Scales
Measured: 1 hour postoperation
Postoperative pain score
Using Visual Analogue Scales
Measured: 4 hours postoperation
Postoperative pain score
Using Visual Analogue Scales
Measured: 8 hours postoperation
Postoperative pain score
Using Visual Analogue Scales
Measured: 24 hours postoperation
Postoperative pain score
Using Visual Analogue Scales
Measured: 48 hours postoperation
Secondary outcomes (27)
Opioid requirement
The dosage of opioids was recorded
Measured: Immediately postoperation
Opioid requirement
The dosage of opioids was recorded
Measured: 1 hour postoperation
Opioid requirement
The dosage of opioids was recorded
Measured: 4 hours postoperation
Opioid requirement
The dosage of opioids was recorded
Measured: 8 hours postoperation
Opioid requirement
The dosage of opioids was recorded
Measured: 24 hours postoperation
Opioid requirement
The dosage of opioids was recorded
Measured: 48 hours postoperation
Pressing times of PCIA postoperation
The pressing times of PCIA within 48 hours postoperation was recorded
Measured: 48 hours postoperation
Occurrence of nausea and/or vomiting
The occurrence of nausea and vomiting within 48 hours postoperation was recorded
Measured: 48 hours postoperation
Blood level of adrenaline
Perioperative blood level of adrenaline was recorded
Measured: before induction
Blood level of adrenaline
Perioperative blood level of adrenaline was recorded
Measured: after incision
Blood level of adrenaline
Perioperative blood level of adrenaline was recorded
Measured: immediately after extubation
Blood level of norepinephrine
Perioperative blood level of norepinephrine was recorded
Measured: before induction
Blood level of norepinephrine
Perioperative blood level of norepinephrine was recorded
Measured: after incision
Blood level of norepinephrine
Perioperative blood level of norepinephrine was recorded
Measured: immediately after extubation
Blood level of adrenocortical
Perioperative blood level of adrenocortical was recorded
Measured: before induction
Blood level of adrenocortical
Perioperative blood level of adrenocortical was recorded
Measured: after incision
Blood level of adrenocortical
Perioperative blood level of adrenocortical was recorded
Measured: immediately after extubation
Blood level of TNF-alpha
Perioperative blood level of TNF-alpha was recorded
Measured: before induction
Blood level of TNF-alpha
Perioperative blood level of TNF-alpha was recorded
Measured: after incision
Blood level of TNF-alpha
Perioperative blood level of TNF-alpha was recorded
Measured: immediately after extubation
Blood level of IL-6
Perioperative blood level of IL-6 was recorded
Measured: before induction
Blood level of IL-6
Perioperative blood level of IL-6 was recorded
Measured: after incision
Blood level of IL-6
Perioperative blood level of IL-6 was recorded
Measured: immediately after extubation
Blood level of IL-10
Perioperative blood level of IL-10 was recorded
Measured: before induction
Blood level of IL-10
Perioperative blood level of IL-10 was recorded
Measured: after incision
Blood level of IL-10
Perioperative blood level of IL-10 was recorded
Measured: immediately after extubation
Duration of hospital stay
length of hospital stay (in days)
Measured: from day of surgery until day of discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start1 Aug 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Congcong Chen, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043624
- Sponsor's protocol ID
- 2019-084
- Status last verified
- Jul 2019
- First submitted
- 19 Jul 2019
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Koppert W, Weigand M, Neumann F, Sittl R, Schuettler J, Schmelz M, Hering W. Perioperative intravenous lidocaine has preventive effects on postoperative pain and morphine consumption after major abdominal surgery. Anesth Analg. 2004 Apr;98(4):1050-1055. doi: 10.1213/01.ANE.0000104582.71710.EE.
PubMed 15041597Schafranski MD, Malucelli T, Machado F, Takeshi H, Kaiber F, Schmidt C, Harth F. Intravenous lidocaine for fibromyalgia syndrome: an open trial. Clin Rheumatol. 2009 Jul;28(7):853-5. doi: 10.1007/s10067-009-1137-8. Epub 2009 Mar 5.
PubMed 19263182Challapalli V, Tremont-Lukats IW, McNicol ED, Lau J, Carr DB. Systemic administration of local anesthetic agents to relieve neuropathic pain. Cochrane Database Syst Rev. 2005 Oct 19;2005(4):CD003345. doi: 10.1002/14651858.CD003345.pub2.
PubMed 16235318Buchanan DD, J MacIvor F. A role for intravenous lidocaine in severe cancer-related neuropathic pain at the end-of-life. Support Care Cancer. 2010 Jul;18(7):899-901. doi: 10.1007/s00520-010-0864-3. Epub 2010 Apr 29.
PubMed 20429016Sharma S, Rajagopal MR, Palat G, Singh C, Haji AG, Jain D. A phase II pilot study to evaluate use of intravenous lidocaine for opioid-refractory pain in cancer patients. J Pain Symptom Manage. 2009 Jan;37(1):85-93. doi: 10.1016/j.jpainsymman.2007.12.023. Epub 2008 Jul 2.
PubMed 18599258Lauwick S, Kim DJ, Michelagnoli G, Mistraletti G, Feldman L, Fried G, Carli F. Intraoperative infusion of lidocaine reduces postoperative fentanyl requirements in patients undergoing laparoscopic cholecystectomy. Can J Anaesth. 2008 Nov;55(11):754-60. doi: 10.1007/BF03016348.
PubMed 19138915Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.
PubMed 17197840Yardeni IZ, Beilin B, Mayburd E, Levinson Y, Bessler H. The effect of perioperative intravenous lidocaine on postoperative pain and immune function. Anesth Analg. 2009 Nov;109(5):1464-9. doi: 10.1213/ANE.0b013e3181bab1bd.
PubMed 19843784Eriksson AS, Sinclair R, Cassuto J, Thomsen P. Influence of lidocaine on leukocyte function in the surgical wound. Anesthesiology. 1992 Jul;77(1):74-8. doi: 10.1097/00000542-199207000-00011.
PubMed 1610012Feng G, Liu S, Wang GL, Liu GJ. Lidocaine attenuates lipopolysaccharide-induced acute lung injury through inhibiting NF-kappaB activation. Pharmacology. 2008;81(1):32-40. doi: 10.1159/000107792. Epub 2007 Sep 4.
PubMed 17785997
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Perioperative Intravenous Infusion of Lidocaine on Postoperative Analgesia in Patients Undergoing Single-port Thoracoscopic
- ClinicalTrials.gov ID
- NCT04043624
- Acronym / sponsor ID
- 2019-084
- Conditions
- Surgery
- Keywords
- single-port thoracoscopic surgery, lidocaine, postoperative pain, opioid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 2 Aug 2019 (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.
The purpose of this study is to evaluate the effect of intravenous lidocaine infusion on pain and opioid dosage in patients undergoing single-port thoracoscopic surgery,and to evaluate the effects of perioperative catecholamine levels, extubation time, incidence of nausea and vomiting, patient satisfaction and hospital stay.
Detailed description
The World Congress on Pain identified pain as the "fifth leading indicator of human life" after breathing, pulse, body temperature and blood pressure. Postoperative pain is an acute nociceptive pain caused by surgical trauma and is a complex stress response in the body, especially in 72 hours after surgery. Pain after thoracic surgery is a more severe type of surgery in various types of surgery.
Acute pain at the early stage of operation is not only an external signal of body injury, but also an independent factor inducing stress response and systemic inflammatory response syndrome (SIRS). Pain stimulus can also cause excessive release of catecholamine, damage of vascular endothelial cells and neutrophil aggregation, which can induce cytokine "waterfall" secretion. Stress, pain and inflammation induce and interact with each other, which seriously affects the early recovery of patients after operation. Timely and effective post-operative analgesia can not only alleviate patients'pain, but also avoid a series of stress reactions. It provides favorable conditions for the stability of patients' physiological function and recovery of their body after operation.
Although multimodal analgesia has largely replaced monotherapy with opioids, they are still the most commonly used drugs for postoperative pain. Lidocaine is an amide local anesthetic which when used intravenously demonstrates significant analgesic, anti-hyperalgesic and anti-inflammatory properties .
Intravenous infusion of lidocaine has a good effect on fibromyalgia, chronic neuropathic pain, opioid tolerance and other chronic pain, and can reduce postoperative acute pain. In the 1960s, Barlett et al. first published a study on the use of lidocaine intravenous infusion for postoperative analgesia.Since then, more and more researchers have begun to explore the use of lidocaine in the treatment of postoperative acute pain.In 2007, Kaba et al. selected patients who underwent colectomy as an experimental subject, and intravenously injected lidocaine during the perioperative period. The results showed that the pain of the experimental group was effectively relieved and the use of opioids was reduced. In 2008, Lauwick et al. used laparoscopic cholecystectomy as the experimental subject. The results showed that the dose of opioid analgesia in the lidocaine group was significantly lower than that in the control group, and the postoperative pain was effectively improved. In 2009, Yardeni et al. selected patients undergoing total hysterectomy as experimental subjects and intravenously injected lidocaine during the perioperative period. The results confirmed that the hemodynamics of the experimental group was more stable, the average dosage of anesthetics was reduced, and the pain was significantly improved.However, to date, there is no strong evidence for the effect of perioperative intravenous infusion of lidocaine in single-port thoracoscopic surgery, so we designed this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine group | Experimental | Drug: LidocaineFirst group (lidocaine group) will include those who receive a intraoperative lidocaine infusion.Induction bolus dose of 1.5 mg/kg body weight ( 30 minutes before incision)followed by a continous lidocaine infusion of 2mg/kg/h，until 1 hours after skin closure. |
| Saline group | Placebo comparator | Drug: SalineThe second group（saline group） will include those who receive a intraoperative placebo.The same dosage of saline was given according to the same method of administration in the lidocaine group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing single-port thoracoscopic with a left double lumen bronchial catheter
- Age ≧ 18 years old, ≦70 years old
- Temperature, white blood cells, and hemoglobin were normal before surgery
- Patient informed consent
Key exclusion criteria (7 listed)
- Patients with a history of surgery within six months
- Patients with dysfunction of heart, liver, kidney, lung, pancreas or other important organs
- American Society of Anesthesiologists (ASA) physical Status classes ≧ Ⅲ
- Allergic to lidocaine
- Bradycardia (heart rate < 60 beats/min) or atrioventricular block
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 |
|---|---|---|
| Lidocaineregimen of lidocaine administration of 1.5 mg/kg, IV bolus, followed by continuous infusion at 2 mg/kg/h | Drug | Lidocaine group |
| SalineIV bolus of saline, followed by continuous infusion of saline | Drug | Saline group |
Primary outcome
Postoperative pain score
Time frame: Immediately postoperation
Using Visual Analogue Scales
Postoperative pain score
Time frame: 1 hour postoperation
Using Visual Analogue Scales
Postoperative pain score
Time frame: 4 hours postoperation
Using Visual Analogue Scales
Postoperative pain score
Time frame: 8 hours postoperation
Using Visual Analogue Scales
Postoperative pain score
Time frame: 24 hours postoperation
Using Visual Analogue Scales
Postoperative pain score
Time frame: 48 hours postoperation
Using Visual Analogue Scales
27 secondary outcomes
Opioid requirement
Time frame: Immediately postoperation
Opioid requirement
Time frame: 1 hour postoperation
Opioid requirement
Time frame: 4 hours postoperation
Opioid requirement
Time frame: 8 hours postoperation
Opioid requirement
Time frame: 24 hours postoperation
Opioid requirement
Time frame: 48 hours postoperation
Pressing times of PCIA postoperation
Time frame: 48 hours postoperation
Occurrence of nausea and/or vomiting
Time frame: 48 hours postoperation
Blood level of adrenaline
Time frame: before induction
Blood level of adrenaline
Time frame: after incision
Blood level of adrenaline
Time frame: immediately after extubation
Blood level of norepinephrine
Time frame: before induction
Blood level of norepinephrine
Time frame: after incision
Blood level of norepinephrine
Time frame: immediately after extubation
Blood level of adrenocortical
Time frame: before induction
Blood level of adrenocortical
Time frame: after incision
Blood level of adrenocortical
Time frame: immediately after extubation
Blood level of TNF-alpha
Time frame: before induction
Blood level of TNF-alpha
Time frame: after incision
Blood level of TNF-alpha
Time frame: immediately after extubation
Blood level of IL-6
Time frame: before induction
Blood level of IL-6
Time frame: after incision
Blood level of IL-6
Time frame: immediately after extubation
Blood level of IL-10
Time frame: before induction
Blood level of IL-10
Time frame: after incision
Blood level of IL-10
Time frame: immediately after extubation
Duration of hospital stay
Time frame: from day of surgery until day of discharge from hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Background: PubMed 15041597Koppert W, Weigand M, Neumann F, Sittl R, Schuettler J, Schmelz M, Hering W. Perioperative intravenous lidocaine has preventive effects on postoperative pain and morphine consumption after major abdominal surgery. Anesth Analg. 2004 Apr;98(4):1050-1055. doi: 10.1213/01.ANE.0000104582.71710.EE.
- Background: PubMed 19263182Schafranski MD, Malucelli T, Machado F, Takeshi H, Kaiber F, Schmidt C, Harth F. Intravenous lidocaine for fibromyalgia syndrome: an open trial. Clin Rheumatol. 2009 Jul;28(7):853-5. doi: 10.1007/s10067-009-1137-8. Epub 2009 Mar 5.
- Background: PubMed 16235318Challapalli V, Tremont-Lukats IW, McNicol ED, Lau J, Carr DB. Systemic administration of local anesthetic agents to relieve neuropathic pain. Cochrane Database Syst Rev. 2005 Oct 19;2005(4):CD003345. doi: 10.1002/14651858.CD003345.pub2.
- Background: PubMed 20429016Buchanan DD, J MacIvor F. A role for intravenous lidocaine in severe cancer-related neuropathic pain at the end-of-life. Support Care Cancer. 2010 Jul;18(7):899-901. doi: 10.1007/s00520-010-0864-3. Epub 2010 Apr 29.
- Background: PubMed 18599258Sharma S, Rajagopal MR, Palat G, Singh C, Haji AG, Jain D. A phase II pilot study to evaluate use of intravenous lidocaine for opioid-refractory pain in cancer patients. J Pain Symptom Manage. 2009 Jan;37(1):85-93. doi: 10.1016/j.jpainsymman.2007.12.023. Epub 2008 Jul 2.
- Background: PubMed 19138915Lauwick S, Kim DJ, Michelagnoli G, Mistraletti G, Feldman L, Fried G, Carli F. Intraoperative infusion of lidocaine reduces postoperative fentanyl requirements in patients undergoing laparoscopic cholecystectomy. Can J Anaesth. 2008 Nov;55(11):754-60. doi: 10.1007/BF03016348.
- Background: PubMed 17197840Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.
- Background: PubMed 19843784Yardeni IZ, Beilin B, Mayburd E, Levinson Y, Bessler H. The effect of perioperative intravenous lidocaine on postoperative pain and immune function. Anesth Analg. 2009 Nov;109(5):1464-9. doi: 10.1213/ANE.0b013e3181bab1bd.
- Background: PubMed 1610012Eriksson AS, Sinclair R, Cassuto J, Thomsen P. Influence of lidocaine on leukocyte function in the surgical wound. Anesthesiology. 1992 Jul;77(1):74-8. doi: 10.1097/00000542-199207000-00011.
- Background: PubMed 17785997Feng G, Liu S, Wang GL, Liu GJ. Lidocaine attenuates lipopolysaccharide-induced acute lung injury through inhibiting NF-kappaB activation. Pharmacology. 2008;81(1):32-40. doi: 10.1159/000107792. Epub 2007 Sep 4.
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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.
Congcong Chen study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine and Saline in people with Surgery, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 7 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 2 Aug 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jin Ma (86+18867539602, 1241370980@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain score (time frame: Immediately postoperation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04043624, which also lists 10 linked publications.
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 2 Aug 2019.