Video-Assisted Thoracic SurgeryPhase 4NCT02980835
Optimal Timing of Intercostal Nerve Blocks During Video-Assisted Thoracic Surgeries
A Phase 4 study testing Normal Saline, Ropivacaine and Epinephrine in people with Video-Assisted Thoracic Surgery and Video-Assisted Thoracoscopic Surgery, run by University at Buffalo at 1 site in United States.
Trial summary
Intercostal nerve block, performed under the guidance of videoscope, is a part of standard anesthesia procedures for patients receiving Video-Assisted Thoracic Surgeries. In this double-blind, prospective, multi-center, randomized, controlled clinical trial the investigators aim to compare preemptive versus… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Video-Assisted Thoracic Surgery, Video-Assisted Thoracoscopic Surgery
- What is being tested?
- Normal Saline, Ropivacaine and Epinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2016to 30 Mar 2022
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be eligible to enroll in this study if they:
- Have physical status within ASA class II or III
- Are between 18 and 85 years of age
- Are candidates for VATS
- Are able to complete VAS assessments
- Are competent to sign the informed consent form
Who cannot join
- Patients will not be enrolled in this study if they:
- Are pregnant
- Have allergy to ropivacaine or hydromorphone
- Have renal insufficiency (eGFR<60mL/min/1.73m2)
- Have hepatic insufficiency (AST, ALT, or both >60 U/L) or cirrhosis
- Have a predicted postoperative forced vital capacity (FVC) of <40%, predicted forced expiratory volume at 1s (FEV1) <40%
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- Have coagulopathy (platelet count<50000, INR>2, or both)
- Have a history of opioid addiction, chronically taking opioids, currently taking high dose of opioids or currently taking opioid agonist+antagonist (e.g. Suboxone®)
- Are taking nonsteroidal anti-inflammatory drug, including aspirin, within a week prior to surgery (since the analgesic effects of NSAID drugs may become confounding factors).
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Western New York Healthcare System
Buffalo, New York, 14215
About this study
Intercostal nerve block, performed under the guidance of videoscope, is a part of standard anesthesia procedures for patients receiving Video-Assisted Thoracic Surgeries. In this double-blind, prospective, multi-center, randomized, controlled clinical trial the investigators aim to compare preemptive versus post-closure intercostal injection of ropivacaine in controlling post-video-assisted thoracotomy pain.
Read the detailed description
The design of the study is a double-blind, prospective, multi-center, randomized, controlled clinical trial of preemptive vs. post-closure intercostal injection of ropivacaine in controlling post-video-assisted thoracotomy (VATS) pain. In standard intercostal nerve block procedures, the contents of A (a total of a 10 mL-solution that consists of 9 mL of ropivacaine HCl 0.5% and 1 mL of dexamethasone 4mg/mL preparation) and C (a total 25 mL solution that consists of 24 mL of ropivacaine HCl 0.5%, 1 mL of dexamethasone-4mg/mL preparation, and 0.125 mL of epinephrine-1:1000 preparation) are combined into one set of injections injected into the intercostal spaces of T5-6, T6-7, T7-8, T8-9 and T9-10, with each intercostal spaces receives about 7 mL of combined A and C solutions (each intercostal space receives 2 mL of A and about 5 mL of C). In this study, the intercostal nerve block is split into two sets of injections: one set of injections at the beginning of VATS, and the other set right before closure. Therefore the investigators consider both sets of injections as research procedures. Patients will be randomly assigned to receive a preemptive 2mL-injection of A or injection of B (contains 10 mL of 0.9% normal saline) at each intercostal space as previously delineated by the operating surgeon. Both the research team and the surgical team will be blind to the nature of the injectates during surgery. As parts of the standard care procedures, all patients will be monitored with non-invasive ASA standard in addition to invasive arterial blood pressure monitoring. Prior to the closure, patients who receive injections of A at the beginning of surgery will receive the second set of injections containing a mixture of B and C (5 mL of solution C is given at each intercostal space) at the intercostal spaces as previously delineated. Patients who receive injections of B at the beginning of surgery will receive the second set of injections containing a mixture of A and C (5 mL of solution C is given at each intercostal space). The investigators will group the patients who are assigned to receive injectate A at the end of the surgery as the control group. Because the injectate A and injectate C are usually given together in one set of injections at the same anatomical locations in standard intercostal nerve block procedures, the intercostal block received by the control group will closely resemble the procedures performed in standard intercostal nerve block. Patients who receive injectate A at the beginning of surgery are grouped as experimental group. Regardless of the group assignment, the total dosage of ropivacaine and dexamethasone given to a patient will be equal to the dosage given under the standard care procedures. Post operative pain, ventilatory profile and length of hospital stay will be compared between two study arms.
- Being tested
- Normal Saline, Ropivacaine, Epinephrine, Dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal SalineDrug
Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectate B contains 10 mL of 0.9% normal saline.
RopivacaineDrug
Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectate A and C contain 9 and 24 mL of ropivacaine HCl 0.5%, respectively.
EpinephrineDrug
Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectate C contains 0.125 mL of epinephrine-1:1000 preparation.
DexamethasoneDrug
Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectates A and C both contain 1 mL of dexamethasone 4mg/mL preparation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients who receive injections of A (a total of a 10 mL-solution that consists of 9 mL of ropivacaine HCl 0.5% and 1 mL of dexamethasone 4mg/mL preparation) at the beginning of surgery and second set of injections containing a mixture of B (contains 10 mL of 0.9% normal saline) and C (a total 25 mL solution that consists of 24 mL of ropivacaine HCl 0.5%, 1 mL of dexamethasone-4mg/mL preparation, and 0.125 mL of epinephrine-1:1000 preparation) prior to the closure Receives: Drug: Normal Saline; Drug: Ropivacaine; Drug: Epinephrine; Drug: Dexamethasone |
| Control | Active comparator | Participants who receive injection of B (contains 10 mL of 0.9% normal saline) at the beginning of surgery and injectate A (a total of a 10 mL-solution that consists of 9 mL of ropivacaine HCl 0.5% and 1 mL of dexamethasone 4mg/mL preparation) and injectate C (a total 25 mL solution that consists of 24 mL of ropivacaine HCl 0.5%, 1 mL of dexamethasone-4mg/mL preparation, and 0.125 mL of epinephrine-1:1000 preparation) at the end of procedure prior to the closure (which mimics standard care) is the control group Receives: Drug: Normal Saline; Drug: Ropivacaine; Drug: Epinephrine; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score
VAS scores at rest will be recorded right after surgery and compared in both groups
Measured: 0
Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score
VAS scores at rest will be recorded 6 hours after surgery and compared in both groups
Measured: 6 hours
Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score
VAS scores at rest will be recorded 12 hours after surgery and compared in both groups
Measured: 12 hours
Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score
VAS scores at rest will be recorded 18 hours after surgery and compared in both groups
Measured: 18 hours
Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score
VAS scores at rest will be recorded 24 hours after surgery and compared in both groups
Measured: 24 hours
Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score
VAS scores at rest will be recorded 48 hours after surgery and compared in both groups
Measured: 48 hours
Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score
VAS scores at rest will be recorded 72 hours after surgery and compared in both groups
Measured: 72 hours
Secondary outcomes (8)
Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC)
Postoperative delirium profiles will be measured 12 hours after surgery using Intensive Care Delirium Screening Checklist (ICDSC)
Measured: 12 hours
Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC)
Postoperative delirium profiles will be measured 24 hours after surgery using Intensive Care Delirium Screening Checklist (ICDSC)
Measured: 24 hours
Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC)
Postoperative delirium profiles will be measured 36 hours after surgery using Intensive Care Delirium Screening Checklist (ICDSC)
Measured: 36 hours
Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC)
Postoperative delirium profiles will be measured 48 hours after surgery using Intensive Care Delirium Screening Checklist (ICDSC)
Measured: 48 hours
PaO2/FIO2 ratio right after surgery
PaO2 (mmHg kPa) and FIO2 (percent) will be recorded from atrial blood gas examination and the ratio will be calculated
Measured: 0 hours
Total hospital length of stay
The investigators will assess length of stay by evaluating medical records and calculate length of stay in days, using date of discharge and date of admission
Measured: up to 2 weeks
Need for non-invasive positive pressure ventilation (NIPPV)
The investigators will assess the need for NIPPV by evaluating medical records to asses if patients received NIPPV with the discretion of the managing physician during their hospitalization
Measured: up to two weeks
Need for mechanical ventilation
The investigators will assess the need for mechanical ventilation by evaluating medical records to asses if patients received mechanical ventilation with the discretion of the managing physician during their hospitalization
Measured: up to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study start28 Sep 2016
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video-Assisted Thoracic SurgeryStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- The VA Western New York Healthcare System
- Responsible party
- Principal investigator, Nader D Nader, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980835
- Sponsor's protocol ID
- 721921
- Status last verified
- Sep 2022
- First submitted
- 22 Nov 2016
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators don't plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Timing of Intercostal Nerve Blocks During Video-Assisted Thoracic Surgeries
- ClinicalTrials.gov ID
- NCT02980835
- Acronym / sponsor ID
- 721921
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University at BuffaloUniversity, hospital or other
- Collaborators
- The VA Western New York Healthcare System
- Study start
- 28 Sep 2016 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 2 Dec 2016 (estimated)
- 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.
Intercostal nerve block, performed under the guidance of videoscope, is a part of standard anesthesia procedures for patients receiving Video-Assisted Thoracic Surgeries. In this double-blind, prospective, multi-center, randomized, controlled clinical trial the investigators aim to compare preemptive versus post-closure intercostal injection of ropivacaine in controlling post-video-assisted thoracotomy pain.
Detailed description
The design of the study is a double-blind, prospective, multi-center, randomized, controlled clinical trial of preemptive vs. post-closure intercostal injection of ropivacaine in controlling post-video-assisted thoracotomy (VATS) pain. In standard intercostal nerve block procedures, the contents of A (a total of a 10 mL-solution that consists of 9 mL of ropivacaine HCl 0.5% and 1 mL of dexamethasone 4mg/mL preparation) and C (a total 25 mL solution that consists of 24 mL of ropivacaine HCl 0.5%, 1 mL of dexamethasone-4mg/mL preparation, and 0.125 mL of epinephrine-1:1000 preparation) are combined into one set of injections injected into the intercostal spaces of T5-6, T6-7, T7-8, T8-9 and T9-10, with each intercostal spaces receives about 7 mL of combined A and C solutions (each intercostal space receives 2 mL of A and about 5 mL of C). In this study, the intercostal nerve block is split into two sets of injections: one set of injections at the beginning of VATS, and the other set right before closure. Therefore the investigators consider both sets of injections as research procedures. Patients will be randomly assigned to receive a preemptive 2mL-injection of A or injection of B (contains 10 mL of 0.9% normal saline) at each intercostal space as previously delineated by the operating surgeon. Both the research team and the surgical team will be blind to the nature of the injectates during surgery. As parts of the standard care procedures, all patients will be monitored with non-invasive ASA standard in addition to invasive arterial blood pressure monitoring. Prior to the closure, patients who receive injections of A at the beginning of surgery will receive the second set of injections containing a mixture of B and C (5 mL of solution C is given at each intercostal space) at the intercostal spaces as previously delineated. Patients who receive injections of B at the beginning of surgery will receive the second set of injections containing a mixture of A and C (5 mL of solution C is given at each intercostal space). The investigators will group the patients who are assigned to receive injectate A at the end of the surgery as the control group. Because the injectate A and injectate C are usually given together in one set of injections at the same anatomical locations in standard intercostal nerve block procedures, the intercostal block received by the control group will closely resemble the procedures performed in standard intercostal nerve block. Patients who receive injectate A at the beginning of surgery are grouped as experimental group. Regardless of the group assignment, the total dosage of ropivacaine and dexamethasone given to a patient will be equal to the dosage given under the standard care procedures. Post operative pain, ventilatory profile and length of hospital stay will be compared between two study arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Normal Saline, Drug: Ropivacaine, Drug: Epinephrine, Drug: DexamethasonePatients who receive injections of A (a total of a 10 mL-solution that consists of 9 mL of ropivacaine HCl 0.5% and 1 mL of dexamethasone 4mg/mL preparation) at the beginning of surgery and second set of injections containing a mixture of B (contains 10 mL of 0.9% normal saline) and C (a total 25 mL solution that consists of 24 mL of ropivacaine HCl 0.5%, 1 mL of dexamethasone-4mg/mL preparation, and 0.125 mL of epinephrine-1:1000 preparation) prior to the closure |
| Control | Active comparator | Drug: Normal Saline, Drug: Ropivacaine, Drug: Epinephrine, Drug: DexamethasoneParticipants who receive injection of B (contains 10 mL of 0.9% normal saline) at the beginning of surgery and injectate A (a total of a 10 mL-solution that consists of 9 mL of ropivacaine HCl 0.5% and 1 mL of dexamethasone 4mg/mL preparation) and injectate C (a total 25 mL solution that consists of 24 mL of ropivacaine HCl 0.5%, 1 mL of dexamethasone-4mg/mL preparation, and 0.125 mL of epinephrine-1:1000 preparation) at the end of procedure prior to the closure (which mimics standard care) is the control group |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have physical status within ASA class II or III
- Are between 18 and 85 years of age
- Are candidates for VATS
- Are able to complete VAS assessments
- Are competent to sign the informed consent form
Key exclusion criteria (9 listed)
- Are pregnant
- Have allergy to ropivacaine or hydromorphone
- Have renal insufficiency (eGFR<60mL/min/1.73m2)
- Have hepatic insufficiency (AST, ALT, or both >60 U/L) or cirrhosis
- Have a predicted postoperative forced vital capacity (FVC) of <40%, predicted forced expiratory volume at 1s (FEV1) <40%
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 |
|---|---|---|
| Normal SalineBlocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectate B contains 10 mL of 0.9% normal saline. | Drug | Control, Intervention |
| RopivacaineBlocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectate A and C contain 9 and 24 mL of ropivacaine HCl 0.5%, respectively. | Drug | Control, Intervention |
| EpinephrineBlocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectate C contains 0.125 mL of epinephrine-1:1000 preparation. | Drug | Control, Intervention |
| DexamethasoneBlocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectates A and C both contain 1 mL of dexamethasone 4mg/mL preparation. | Drug | Control, Intervention |
Primary outcome
Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score
Time frame: 0
VAS scores at rest will be recorded right after surgery and compared in both groups
Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score
Time frame: 6 hours
VAS scores at rest will be recorded 6 hours after surgery and compared in both groups
Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score
Time frame: 12 hours
VAS scores at rest will be recorded 12 hours after surgery and compared in both groups
Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score
Time frame: 18 hours
VAS scores at rest will be recorded 18 hours after surgery and compared in both groups
Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score
Time frame: 24 hours
VAS scores at rest will be recorded 24 hours after surgery and compared in both groups
Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score
Time frame: 48 hours
VAS scores at rest will be recorded 48 hours after surgery and compared in both groups
Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score
Time frame: 72 hours
VAS scores at rest will be recorded 72 hours after surgery and compared in both groups
8 secondary outcomes
Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC)
Time frame: 12 hours
Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC)
Time frame: 24 hours
Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC)
Time frame: 36 hours
Postoperative delirium profiles measured using Intensive Care Delirium Screening Checklist (ICDSC)
Time frame: 48 hours
PaO2/FIO2 ratio right after surgery
Time frame: 0 hours
Total hospital length of stay
Time frame: up to 2 weeks
Need for non-invasive positive pressure ventilation (NIPPV)
Time frame: up to two weeks
Need for mechanical ventilation
Time frame: up to two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Individual participant dataSharing planned: No. The investigators don't plan to make individual participant data (IPD) available to other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Normal Saline, Ropivacaine and Epinephrine in people with Video-Assisted Thoracic Surgery and Video-Assisted Thoracoscopic Surgery, run by University at Buffalo at 1 site in United States.
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 6 inclusion and 9 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: finished, as of the sponsor's last update on 22 Sep 2022. 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 United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of intercostal nerve block in reducing postoperative pain, when performed at the beginning of video-assisted thoracic surgeries by visual analog scale (VAS) score (time frame: 0). The study lists 7 primary outcomes in all. 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 22 Sep 2022.