Post Thoracotomy PainPhase 3NCT04482192
Continuous Paravertebral Block by Intraoperative Direct Access Versus Systemic Analgesia for Postthoracotomy Pain Relief
A Phase 3 study testing Thoracic paravertebral block and Systemic analgesia in people with Post Thoracotomy Pain, run by Zagazig University.
Trial summary
to evaluate the safety and efficacy of continuous paravertebral block by intraoperative direct access on postthoracotomy pain compared to systemic analgesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Thoracotomy Pain
- What is being tested?
- Thoracic paravertebral block and Systemic analgesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2015to 31 Mar 2020
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Elective posterolateral thoracotomy surgery
- American Society of Anesthesiologists (ASA) physical status of II and III
Who cannot join
- • lack of patient consent.
- patients younger than 18 years,
- emergency surgery,
- previous thoracotomy,
- drug addiction,
- allergy to paracetamol (acetaminophen) or ketorolac,
Show all 10Show fewer
- coagulopathy,
- hepatic dysfunction,
- chronic renal failure,
- history of gastric ulcer
About this study
to evaluate the safety and efficacy of continuous paravertebral block by intraoperative direct access on postthoracotomy pain compared to systemic analgesia.
Read the detailed description
Based on a pilot study of 20 participants, 10 in each group, the mean visual analogue score of pain at rest (VAS) ± Standard Deviation (SD) at 6 hours postoperatively for Thoracic paravertebral block group (TPVB) participants were 3.0 ± 1.4 and that for systemic analgesia (SA) participants were 4.2 ± 1.6. The calculated significant sample size with a power of 0.85 and alpha error of 0.05 was 60 participants, with 1:1 allocation in each group.
Eighty two participants were assessed for eligibility criteria to be included in the study, 18 participants were excluded pre-randomization, and one participant was excluded post-randomization due to re-exploration for bleeding. Sixty three participants were analyzed in the study. Thoracic paravertebral block group (TPVB group) included 32 participants and systemic analgesia group (SA group) included 31 participants.
Technique of intraoperative paravertebral catheter insertion:
The investigators used the technique that was described by Sabanathan et al in 1988[14] and modified by them in 1990 [15]. After completing the surgical pulmonary procedure and with the chest is still open, starting from the posterior end of the thoracotomy, parietal pleura is raised from the posterior chest wall to the vertebral body and for two spaces above and below the incision of thoracotomy creating a pouch. A 16-gauge disposable Tuohy needle is inserted percutaneously through a low posterior interspace. The needle is advanced until the tip appeared in the created pouch. The stylet is removed, and a 16-gauge side-holed epidural catheter is advanced into the created pouch and the needle is withdrawn. Using a curved forceps, a small defect is done in the extrapleural fascia to be directly in the paravertebral space. The cannula is passed to the paravertebral space through the defect and advanced cranially for 2 to 3 cm. The parietal pleura is reattached to the posterior edge of the wound and the catheter is secured. Then a bolus dose 15-20 ml of 1% lidocaine is injected through the catheter and the chest is closed as usual with one or two intercostal drainage tubes according to the surgical procedure.
Protocol of analgesia:
All participants, in both groups, received intravenous analgesia with 1gm paracetamol and 30 mg ketorolac half an hour before the end of surgery.
Systemic analgesia (SA) group continue to receive 1gm paracetamol and 30 mg ketorolac by intravenous infusion every 6 hours for 3 days. Thoracic paravertebral block (TPVB) group received continuous infusion of 0.1 ml/kg/h of 1.0% lidocaine (l mg/kg/h) using infusion pump through the inserted paravertebral catheter for 3 days. Intravenous morphine sulfate (0.05mg/kg) was given as a rescue medication if the VAS ≥ 4 for both groups. A senior nurse was responsible for handling the analgesia regimen and another nurse was responsible for recording pain score on visual analogue scale (VAS) and morphine consumption, as scheduled.
- Conditions
- Post Thoracotomy Pain
- Being tested
- Thoracic paravertebral block, Systemic analgesia
- Keywords
- Paravertebral block, Postthoracotomy analgesia, Systemic analgesia, Lidocaine infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic paravertebral blockCombination product
Also called Study group
After ending pulmonary procedure, a pleural pouch created beside vertebral column, a catheter is inserted to the pouch for continuous infusion of 1% lidocaine for 3 postoperative days. Intravenous morphine sulfate (0.05mg/kg) was given as a rescue medication if the VAS ≥ 4.
Systemic analgesiaDrug
Also called Control group
Systemic analgesia (SA) group receive 1gm paracetamol and 30 mg ketorolac by intravenous infusion every 6 hours for 3 days. Intravenous morphine sulfate (0.05mg/kg) was given as a rescue medication if the VAS ≥ 4.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic paravertebral block group | Active comparator | Continuous thoracic paravertebral block with 1% lidocaine infusion for 3 postoperative days through a paravertebral catheter inserted intraoperatively by the surgeon. Receives: Combination Product: Thoracic paravertebral block |
| Systemic analgesia group | Active comparator | patients in this group will receive paracetamol and ketorolac by intravenous infusion every 6 hours for 3 postoperative days Receives: Drug: Systemic analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score on visual analogue scale (VAS) at rest
Paper-based visual analogue scale (VAS) is used for pain assessment. It provides a range of scores from 0-10. A higher score indicates greater pain intensity.
Measured: 24 hours after operation
Pain score on visual analogue scale (VAS) on coughing
Paper-based visual analogue scale (VAS) is used for pain assessment. It provides a range of scores from 0-10. A higher score indicates greater pain intensity.
Measured: 24 hours after operation
Secondary outcomes (4)
Total morphine consumption
The summation of morphine consumption of the participant
Measured: end of first postoperative day
Forced vital capacity (FVC)
measured by spirometer (Microspiro HI-298, Chest Corporation, Tokyo, Japan)
Measured: 24 hours after operation
Forced expiratory volume in 1s (FEV1)
measured by spirometer (Microspiro HI-298, Chest Corporation, Tokyo, Japan)
Measured: 24 hours after operation
Peak expiratory flow rate (PEFR)
measured by spirometer (Microspiro HI-298, Chest Corporation, Tokyo, Japan)
Measured: 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start15 Jun 2015
- Primary completion31 Jan 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Post Thoracotomy PainStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmed Deebis, Zagazig University
- Investigators
- Ahmed Deebis, MD, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482192
- Sponsor's protocol ID
- ZU-IRB: 6289
- Status last verified
- Jul 2020
- First submitted
- 16 Jul 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All authors of the study will share individual participant data (IPD)
Publications
Krakowski JC, Arora H. Con: Thoracic Epidural Block Is Not Superior to Paravertebral Blocks for Open Thoracic Surgery. J Cardiothorac Vasc Anesth. 2015 Dec;29(6):1720-2. doi: 10.1053/j.jvca.2015.06.012. Epub 2015 Jun 10. No abstract available.
PubMed 26386503Fortier S, Hanna HA, Bernard A, Girard C. Comparison between systemic analgesia, continuous wound catheter analgesia and continuous thoracic paravertebral block: a randomised, controlled trial of postthoracotomy pain management. Eur J Anaesthesiol. 2012 Nov;29(11):524-30. doi: 10.1097/EJA.0b013e328357e5a1.
PubMed 22914044Sabanathan S, Smith PJ, Pradhan GN, Hashimi H, Eng JB, Mearns AJ. Continuous intercostal nerve block for pain relief after thoracotomy. Ann Thorac Surg. 1988 Oct;46(4):425-6. doi: 10.1016/s0003-4975(10)64657-7.
PubMed 3178353Berrisford RG, Sabanathan SS. Direct access to the paravertebral space at thoracotomy. Ann Thorac Surg. 1990 May;49(5):854. doi: 10.1016/0003-4975(90)90058-e. No abstract available.
PubMed 2339953Wojtys ME, Wasikowski J, Wojcik N, Wojcik J, Wasilewski P, Lisowski P, Grodzki T. Assessment of postoperative pain management and comparison of effectiveness of pain relief treatment involving paravertebral block and thoracic epidural analgesia in patients undergoing posterolateral thoracotomy. J Cardiothorac Surg. 2019 Apr 16;14(1):78. doi: 10.1186/s13019-019-0901-3.
PubMed 30992044Elia N, Lysakowski C, Tramer MR. Does multimodal analgesia with acetaminophen, nonsteroidal antiinflammatory drugs, or selective cyclooxygenase-2 inhibitors and patient-controlled analgesia morphine offer advantages over morphine alone? Meta-analyses of randomized trials. Anesthesiology. 2005 Dec;103(6):1296-304. doi: 10.1097/00000542-200512000-00025.
PubMed 16306743Batra RK, Krishnan K, Agarwal A. Paravertebral block. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):5-11. No abstract available.
PubMed 21804697Katayama T, Hirai S, Kobayashi R, Hamaishi M, Okada T, Mitsui N. Safety of the paravertebral block in patients ineligible for epidural block undergoing pulmonary resection. Gen Thorac Cardiovasc Surg. 2012 Dec;60(12):811-4. doi: 10.1007/s11748-012-0149-5. Epub 2012 Sep 16.
PubMed 22983833
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Paravertebral Block by Intraoperative Direct Access Versus Systemic Analgesia for Postthoracotomy Pain Relief
- ClinicalTrials.gov ID
- NCT04482192
- Acronym / sponsor ID
- ZU-IRB: 6289
- Conditions
- Post Thoracotomy Pain
- Keywords
- Paravertebral block, Postthoracotomy analgesia, Systemic analgesia, Lidocaine infusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 Jun 2015 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 22 Jul 2020 (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.
to evaluate the safety and efficacy of continuous paravertebral block by intraoperative direct access on postthoracotomy pain compared to systemic analgesia.
Detailed description
Based on a pilot study of 20 participants, 10 in each group, the mean visual analogue score of pain at rest (VAS) ± Standard Deviation (SD) at 6 hours postoperatively for Thoracic paravertebral block group (TPVB) participants were 3.0 ± 1.4 and that for systemic analgesia (SA) participants were 4.2 ± 1.6. The calculated significant sample size with a power of 0.85 and alpha error of 0.05 was 60 participants, with 1:1 allocation in each group.
Eighty two participants were assessed for eligibility criteria to be included in the study, 18 participants were excluded pre-randomization, and one participant was excluded post-randomization due to re-exploration for bleeding. Sixty three participants were analyzed in the study. Thoracic paravertebral block group (TPVB group) included 32 participants and systemic analgesia group (SA group) included 31 participants.
Technique of intraoperative paravertebral catheter insertion:
The investigators used the technique that was described by Sabanathan et al in 1988[14] and modified by them in 1990 [15]. After completing the surgical pulmonary procedure and with the chest is still open, starting from the posterior end of the thoracotomy, parietal pleura is raised from the posterior chest wall to the vertebral body and for two spaces above and below the incision of thoracotomy creating a pouch. A 16-gauge disposable Tuohy needle is inserted percutaneously through a low posterior interspace. The needle is advanced until the tip appeared in the created pouch. The stylet is removed, and a 16-gauge side-holed epidural catheter is advanced into the created pouch and the needle is withdrawn. Using a curved forceps, a small defect is done in the extrapleural fascia to be directly in the paravertebral space. The cannula is passed to the paravertebral space through the defect and advanced cranially for 2 to 3 cm. The parietal pleura is reattached to the posterior edge of the wound and the catheter is secured. Then a bolus dose 15-20 ml of 1% lidocaine is injected through the catheter and the chest is closed as usual with one or two intercostal drainage tubes according to the surgical procedure.
Protocol of analgesia:
All participants, in both groups, received intravenous analgesia with 1gm paracetamol and 30 mg ketorolac half an hour before the end of surgery.
Systemic analgesia (SA) group continue to receive 1gm paracetamol and 30 mg ketorolac by intravenous infusion every 6 hours for 3 days. Thoracic paravertebral block (TPVB) group received continuous infusion of 0.1 ml/kg/h of 1.0% lidocaine (l mg/kg/h) using infusion pump through the inserted paravertebral catheter for 3 days. Intravenous morphine sulfate (0.05mg/kg) was given as a rescue medication if the VAS ≥ 4 for both groups. A senior nurse was responsible for handling the analgesia regimen and another nurse was responsible for recording pain score on visual analogue scale (VAS) and morphine consumption, as scheduled.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic paravertebral block group | Active comparator | Combination Product: Thoracic paravertebral blockContinuous thoracic paravertebral block with 1% lidocaine infusion for 3 postoperative days through a paravertebral catheter inserted intraoperatively by the surgeon. |
| Systemic analgesia group | Active comparator | Drug: Systemic analgesiapatients in this group will receive paracetamol and ketorolac by intravenous infusion every 6 hours for 3 postoperative days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- • Elective posterolateral thoracotomy surgery
Key exclusion criteria (10 listed)
- • lack of patient consent.
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 |
|---|---|---|
| Thoracic paravertebral blockAlso: Study groupAfter ending pulmonary procedure, a pleural pouch created beside vertebral column, a catheter is inserted to the pouch for continuous infusion of 1% lidocaine for 3 postoperative days. Intravenous morphine sulfate (0.05mg/kg) was given as a rescue medication if the VAS ≥ 4. | Combination product | Thoracic paravertebral block group |
| Systemic analgesiaAlso: Control groupSystemic analgesia (SA) group receive 1gm paracetamol and 30 mg ketorolac by intravenous infusion every 6 hours for 3 days. Intravenous morphine sulfate (0.05mg/kg) was given as a rescue medication if the VAS ≥ 4. | Drug | Systemic analgesia group |
Primary outcome
Pain score on visual analogue scale (VAS) at rest
Time frame: 24 hours after operation
Paper-based visual analogue scale (VAS) is used for pain assessment. It provides a range of scores from 0-10. A higher score indicates greater pain intensity.
Pain score on visual analogue scale (VAS) on coughing
Time frame: 24 hours after operation
Paper-based visual analogue scale (VAS) is used for pain assessment. It provides a range of scores from 0-10. A higher score indicates greater pain intensity.
4 secondary outcomes
Total morphine consumption
Time frame: end of first postoperative day
Forced vital capacity (FVC)
Time frame: 24 hours after operation
Forced expiratory volume in 1s (FEV1)
Time frame: 24 hours after operation
Peak expiratory flow rate (PEFR)
Time frame: 24 hours after operation
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 23 Jul 2020.
- Results publication: PubMed 26386503Krakowski JC, Arora H. Con: Thoracic Epidural Block Is Not Superior to Paravertebral Blocks for Open Thoracic Surgery. J Cardiothorac Vasc Anesth. 2015 Dec;29(6):1720-2. doi: 10.1053/j.jvca.2015.06.012. Epub 2015 Jun 10. No abstract available.
- Results publication: PubMed 22914044Fortier S, Hanna HA, Bernard A, Girard C. Comparison between systemic analgesia, continuous wound catheter analgesia and continuous thoracic paravertebral block: a randomised, controlled trial of postthoracotomy pain management. Eur J Anaesthesiol. 2012 Nov;29(11):524-30. doi: 10.1097/EJA.0b013e328357e5a1.
- Results publication: PubMed 3178353Sabanathan S, Smith PJ, Pradhan GN, Hashimi H, Eng JB, Mearns AJ. Continuous intercostal nerve block for pain relief after thoracotomy. Ann Thorac Surg. 1988 Oct;46(4):425-6. doi: 10.1016/s0003-4975(10)64657-7.
- Results publication: PubMed 2339953Berrisford RG, Sabanathan SS. Direct access to the paravertebral space at thoracotomy. Ann Thorac Surg. 1990 May;49(5):854. doi: 10.1016/0003-4975(90)90058-e. No abstract available.
- Results publication: PubMed 30992044Wojtys ME, Wasikowski J, Wojcik N, Wojcik J, Wasilewski P, Lisowski P, Grodzki T. Assessment of postoperative pain management and comparison of effectiveness of pain relief treatment involving paravertebral block and thoracic epidural analgesia in patients undergoing posterolateral thoracotomy. J Cardiothorac Surg. 2019 Apr 16;14(1):78. doi: 10.1186/s13019-019-0901-3.
- Results publication: PubMed 16306743Elia N, Lysakowski C, Tramer MR. Does multimodal analgesia with acetaminophen, nonsteroidal antiinflammatory drugs, or selective cyclooxygenase-2 inhibitors and patient-controlled analgesia morphine offer advantages over morphine alone? Meta-analyses of randomized trials. Anesthesiology. 2005 Dec;103(6):1296-304. doi: 10.1097/00000542-200512000-00025.
- Results publication: PubMed 21804697Batra RK, Krishnan K, Agarwal A. Paravertebral block. J Anaesthesiol Clin Pharmacol. 2011 Jan;27(1):5-11. No abstract available.
- Results publication: PubMed 22983833Katayama T, Hirai S, Kobayashi R, Hamaishi M, Okada T, Mitsui N. Safety of the paravertebral block in patients ineligible for epidural block undergoing pulmonary resection. Gen Thorac Cardiovasc Surg. 2012 Dec;60(12):811-4. doi: 10.1007/s11748-012-0149-5. Epub 2012 Sep 16.
- Procedure specific postoperative pain management. (2015) Thoracotomy.Link provided by the sponsor.
- 11\. Rosenblatti M A, Lai Y, Thoracic nerve block techniques UpTo Date Topic 100071 Version 24.0, last updated: Jun 10, 2019.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. All authors of the study will share individual participant data (IPD)
Related trials for Post Thoracotomy Pain
RecruitingPhase 2/3
Comparing Suprascapular Nerve Block and Interscalene Block for Post-thoracotomy Pain in Pediatric Patients.
Nerve Block/Methods
Not yet recruiting
Comparison of Paravertebral Versus Epidural Block for Post-thoracotomy Pain Control
Postoperative Pain
Recruiting
Efficacy of Dexmedetomidine VS Magnesium Sulphate With Bupivacaine in Erector Spinae Block for Thoracotomy Pain
Analgesia
Recruiting
SPS Block vs. Surgical Intercostal Block for Chronic Pain After Thoracoscopic Surgery
Chronic Post-thoracotomy Pain, Neuropathic Pain
Not yet recruiting
Analgesic Efficiency of Erector Spinae Plane Block Versus Thoracic Paravertebral Block in Patients Undergoing Lateral Thoracotomy Using Opoid Sparing Anesthesia
Post Thoracotomy Pain
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.
Ahmed Deebis, MD principal investigator
Zagazig University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thoracic paravertebral block and Systemic analgesia in people with Post Thoracotomy Pain, run by Zagazig University.
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 2 inclusion and 10 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 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 score on visual analogue scale (VAS) at rest (time frame: 24 hours after operation). The study lists 2 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 NCT04482192, which also lists 8 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 23 Jul 2020.