Lung CancerPhase 2NCT02040662
Comparison of Efficacy of Paravertebral and Epidural Analgesia After Videothoracoscopic Lung Lobectomy
A Phase 2 study testing Continuous Thoracic Epidural Block and Continuous Thoracic Paravertebral Block in people with Lung Cancer, run by Pulmonary Hospital Zakopane at 1 site in Poland.
Trial summary
Thoracic surgery correlates with significant pain in postoperative period. In order to alleviate the pain various combinations of pharmaceuticals and administration methods are employed. So as to reduce the extent of surgical trauma and, consequently, correlated pain various operation techniques are used. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Continuous Thoracic Epidural Block and Continuous Thoracic Paravertebral Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2013to Jul 2014
- Phase
- Phase 2
- 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
- American Society of Anesthesiologists (ASA) physical status 1-3
- undergo videothoracoscopic lung lobectomy
- forced expiratory volume in 1 second (FEV1) >1,5 l/min
- no contraindications for epidural anesthesia and paravertebral nerve blockade
- ability to comprehend principles of VAS pain examination method and to communicate in accordance with them.
Who cannot join
- prior to the study: contraindications for local anesthesia, ASA>3, FEV1<1,5 l/min, conditions disabling the patient from comprehending the principles of VAS pain examination, known allergy to used medications.
- during the study: failure to place epidural or paravertebral catheter, decision to abandon lobar resection (e.g. in case of neoplastic dissemination), intraoperative conversion to thoracotomy, intraoperative anatomical obstacles to distribution of local anesthetics, conditions disabling the patient from pain evaluation by means of VAS method (e.g. postoperative delirium), necessity to administer other pharmaceuticals influencing pain perception (e.g. sedatives), necessity of mechanical ventilation, interruption of local anesthesia as a result of technical problems (e.g. damage or slippage of catheter).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Continuous Epidural and Continuous Paravertebral Blockade in Postoperative Analgesia After Videothoracoscopic Lung Lobectomy
Thoracic surgery correlates with significant pain in postoperative period. In order to alleviate the pain various combinations of pharmaceuticals and administration methods are employed. So as to reduce the extent of surgical trauma and, consequently, correlated pain various operation techniques are used. In traditional thoracotomy epidural anesthesia remains a golden standard. Epidural anesthesia however demands high skills to be performed correctly and presents an increased risk of grave complications. In videothoracoscopic (VATS) operations paravertebral blockade can be employed, yet there is no certainty if its efficacy after lung lobectomy. We therefore designed a prospective, randomized, parallel group, single site study to test the hypothesis, that continuous paravertebral blockade is as efficient in postoperative pain reduction as continuous epidural blockade and possesses a higher safety profile.
- Conditions
- Lung Cancer
- Being tested
- Continuous Thoracic Epidural Block, Continuous Thoracic Paravertebral Block, Patient-Controlled Analgesia with Morphine
- Keywords
- paravertebral block, thoracic epidural analgesia, videothoracoscopic surgery, lung lobectomy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Thoracic Epidural BlockProcedure or surgery
Before anesthesia, continuous thoracic epidural block of T5/T6 is performed (Portex Epidural Minipack set). Identification of paravertebral space by loss of resistance technique (air). A catheter is advanced ca. 3-5 cm, and test dose with 2 ml of lidocaine 2% i injected. At the end of surgery syringe with 0,25% bupivacaine with epinephrine 1:200.000 is connected to catheter and 6 ml bolus is injected, followed by an infusion of the same mixture at 0,06 ml/kg/h for postoperative pain management.
Continuous Thoracic Paravertebral BlockProcedure or surgery
Before anesthesia, continuous thoracic paravertebral block of T5/T6 is performed (Portex Epidural Minipack set). Identification of paravertebral space by loss of resistance technique (normal saline). After injection of 5-10 ml of normal saline a catheter is advanced medially ca. 5 cm. At the end of surgery syringe with 0,25% bupivacaine with epinephrine 1:200.000 is connected to catheter and 20 ml bolus is injected, followed by an infusion of the same mixture at 0,08 ml/kg/h for postoperative pain management
Patient-Controlled Analgesia with MorphineProcedure or surgery
Once arrived at the PACU all patients are placed on a postoperative analgesia regimen, that include:
- patient-controlled analgesia with morphine (bolus dose 2 mg, lockout time 10 min)
- paracetamol 1000 mg iv every 8 hrs
- ketoprofen 100 mg iv every 12 hrs
| Study group | Role | What they receive |
|---|---|---|
| Continuous Thoracic Paravertebral Block | Experimental | 1. continuous thoracic paravertebral blockade 0,08 ml/kg/h with bupivacaine 0,25% + epinephrine 1:200.000
2. patient-controlled analgesia (morphine), bolus dose 2 mg, lockout time 10 min Receives: Procedure: Continuous Thoracic Paravertebral Block; Procedure: Patient-Controlled Analgesia with Morphine |
| Continuous Thoracic Epidural Analgesia | Experimental | 1. continuous thoracic epidural block 0,06 ml/kg/h with bupivacaine 0,25% + epinephrine 1:200.000
2. patient-controlled analgesia (morphine), bolus dose 2 mg, lockout time 10 min Receives: Procedure: Continuous Thoracic Epidural Block; Procedure: Patient-Controlled Analgesia with Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity measured in VAS in predetermined time intervals after the operation
Measured: up to 96 hrs after the surgery
Secondary outcomes (4)
respiratory parameters indirectly indicating conditions for efficient cough: peak expiratory flow (PEF), forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC)
Measured: up to 96 hrs after the surgery
frequency of side effects of regional anesthesia: urine retention resulting in necessity of bladder catheterization, hypotension, respiratory depression
Measured: up to 96 hrs after surgery
frequency of respiratory complications: atelectasis or pneumonia
Measured: up to 96 hrs after surgery
cumulative opioid (morphine) consumption
Measured: up to 96 hrs after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startJan 2013
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmonary Hospital Zakopane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040662
- Sponsor's protocol ID
- 1/2014
- Status last verified
- Jun 2017
- First submitted
- 13 Jan 2014
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Continuous Epidural and Continuous Paravertebral Blockade in Postoperative Analgesia After Videothoracoscopic Lung Lobectomy
- ClinicalTrials.gov ID
- NCT02040662
- Acronym / sponsor ID
- 1/2014
- Conditions
- Lung Cancer
- Keywords
- paravertebral block, thoracic epidural analgesia, videothoracoscopic surgery, lung lobectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Pulmonary Hospital ZakopaneUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 20 Jan 2014 (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.
Thoracic surgery correlates with significant pain in postoperative period. In order to alleviate the pain various combinations of pharmaceuticals and administration methods are employed. So as to reduce the extent of surgical trauma and, consequently, correlated pain various operation techniques are used. In traditional thoracotomy epidural anesthesia remains a golden standard. Epidural anesthesia however demands high skills to be performed correctly and presents an increased risk of grave complications. In videothoracoscopic (VATS) operations paravertebral blockade can be employed, yet there is no certainty if its efficacy after lung lobectomy. We therefore designed a prospective, randomized, parallel group, single site study to test the hypothesis, that continuous paravertebral blockade is as efficient in postoperative pain reduction as continuous epidural blockade and possesses a higher safety profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Thoracic Paravertebral Block | Experimental | Procedure: Continuous Thoracic Paravertebral Block, Procedure: Patient-Controlled Analgesia with Morphine1. continuous thoracic paravertebral blockade 0,08 ml/kg/h with bupivacaine 0,25% + epinephrine 1:200.000 2. patient-controlled analgesia (morphine), bolus dose 2 mg, lockout time 10 min |
| Continuous Thoracic Epidural Analgesia | Experimental | Procedure: Continuous Thoracic Epidural Block, Procedure: Patient-Controlled Analgesia with Morphine1. continuous thoracic epidural block 0,06 ml/kg/h with bupivacaine 0,25% + epinephrine 1:200.000 2. patient-controlled analgesia (morphine), bolus dose 2 mg, lockout time 10 min |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- American Society of Anesthesiologists (ASA) physical status 1-3
- undergo videothoracoscopic lung lobectomy
- forced expiratory volume in 1 second (FEV1) >1,5 l/min
- no contraindications for epidural anesthesia and paravertebral nerve blockade
- ability to comprehend principles of VAS pain examination method and to communicate in accordance with them.
Key exclusion criteria (2 listed)
- prior to the study: contraindications for local anesthesia, ASA>3, FEV1<1,5 l/min, conditions disabling the patient from comprehending the principles of VAS pain examination, known allergy to used medications.
- during the study: failure to place epidural or paravertebral catheter, decision to abandon lobar resection (e.g. in case of neoplastic dissemination), intraoperative conversion to thoracotomy, intraoperative anatomical obstacles to distribution of local anesthetics, conditions disabling the patient from pain evaluation by means of VAS method (e.g. postoperative delirium), necessity to administer other pharmaceuticals influencing pain perception (e.g. sedatives), necessity of mechanical ventilation, interruption of local anesthesia as a result of technical problems (e.g. damage or slippage of catheter).
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 |
|---|---|---|
| Continuous Thoracic Epidural BlockBefore anesthesia, continuous thoracic epidural block of T5/T6 is performed (Portex Epidural Minipack set). Identification of paravertebral space by loss of resistance technique (air). A catheter is advanced ca. 3-5 cm, and test dose with 2 ml of lidocaine 2% i injected. At the end of surgery syringe with 0,25% bupivacaine with epinephrine 1:200.000 is connected to catheter and 6 ml bolus is injected, followed by an infusion of the same mixture at 0,06 ml/kg/h for postoperative pain management. | Procedure or surgery | Continuous Thoracic Epidural Analgesia |
| Continuous Thoracic Paravertebral BlockBefore anesthesia, continuous thoracic paravertebral block of T5/T6 is performed (Portex Epidural Minipack set). Identification of paravertebral space by loss of resistance technique (normal saline). After injection of 5-10 ml of normal saline a catheter is advanced medially ca. 5 cm. At the end of surgery syringe with 0,25% bupivacaine with epinephrine 1:200.000 is connected to catheter and 20 ml bolus is injected, followed by an infusion of the same mixture at 0,08 ml/kg/h for postoperative pain management | Procedure or surgery | Continuous Thoracic Paravertebral Block |
| Patient-Controlled Analgesia with MorphineOnce arrived at the PACU all patients are placed on a postoperative analgesia regimen, that include: * patient-controlled analgesia with morphine (bolus dose 2 mg, lockout time 10 min) * paracetamol 1000 mg iv every 8 hrs * ketoprofen 100 mg iv every 12 hrs | Procedure or surgery | Continuous Thoracic Epidural Analgesia, Continuous Thoracic Paravertebral Block |
Primary outcome
pain intensity measured in VAS in predetermined time intervals after the operation
Time frame: up to 96 hrs after the surgery
4 secondary outcomes
respiratory parameters indirectly indicating conditions for efficient cough: peak expiratory flow (PEF), forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC)
Time frame: up to 96 hrs after the surgery
frequency of side effects of regional anesthesia: urine retention resulting in necessity of bladder catheterization, hypotension, respiratory depression
Time frame: up to 96 hrs after surgery
frequency of respiratory complications: atelectasis or pneumonia
Time frame: up to 96 hrs after surgery
cumulative opioid (morphine) consumption
Time frame: up to 96 hrs after surgery
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 12 Jun 2017.
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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 2 study testing Continuous Thoracic Epidural Block and Continuous Thoracic Paravertebral Block in people with Lung Cancer, run by Pulmonary Hospital Zakopane at 1 site in Poland.
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 5 inclusion and 2 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 12 Jun 2017. 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 Poland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
pain intensity measured in VAS in predetermined time intervals after the operation (time frame: up to 96 hrs after the surgery). 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 12 Jun 2017.