Chest PainPhase 4NCT02469610
Assessment of Intercostal Block Scheduling in Preventing Acute Surgical and Post-surgical Pain in Thoracoscopic Surgery
A Phase 4 study testing Intercostal block Bupivacaine based in people with Chest Pain and Surgery, run by Carmel Medical Center at 1 site in Israel.
Trial summary
It is well known that chest surgery patients suffer from high level pain in the perioperative period. The transition to thoracoscopic approaches reduced surgical pain. The proper pain control technique for thoracoscopic approaches is still under debate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain, Surgery
- What is being tested?
- Intercostal block Bupivacaine based
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2015to 25 Jun 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Thoracoscopic surgery candidate.
- Over 18 years old.
- No known allergy to Bupivacaine.
- Patient is able to read understand and singe an inform consent.
Who cannot join
- Previous thoracic operation in the same side.
Trial locations and contacts
1 site in 1 country.
About this study
It is well known that chest surgery patients suffer from high level pain in the perioperative period. The transition to thoracoscopic approaches reduced surgical pain. The proper pain control technique for thoracoscopic approaches is still under debate. One of the most popular methods for pain control is these procedures is the Intercostal block. The Intercostal block is usually based upon topical analgesic. In this study the investigators will try to examine the effect on pain control of the timing of Intercostal block of 100 mg BUPIVACAINE. The study is a prospective comparative study. The cohort will be divided into two groups. In the control group patients will have Intercostal block after surgery and in the study group the intercostal block will be given in the beginning of the surgical procedure. All other analgesic treatment during and post-surgery will be the same in both groups. The study will evaluate pain level in the days after the surgery, analgesic medication consumption and relevant morbidity.
Read the detailed description
Intercostal Bupivacaine block Intercostal block is a procedure during which a local anesthetic is injected to the intercostal space. This space includes the rote of the intercostal nerve. The purpose of the procedure is to block the neuropathic pain that developed due to inflammation and irritation of the nerve and other close structures. Some add steroids to the injection because of their anti-inflammatory effect.
Bupivacaine is a local anesthetic. It belongs to a group of medicines called amide- type local anesthetics. It is a well-known medication with many years of documented use in local and regional anesthesia. Bupivacaine binds to the intracellular portion of voltage-gated sodium channels and blocks sodium influx into nerve cells. This block prevents depolarization. The lack of depolarization precludes initiation or conduction of a pain signal can occur.
Study Aims This study will try to evaluate the difference in pain control during and post thoracoscopic surgery in patients who had bupivacaine intercostal block before versus after surgery.
The study main end point is the amount of analgesic medication consumption by patients during and after thoracoscopic surgery.
Secondary end points will include subjective patient's pain evaluation, length of hospital stay and post-operative complication.
Inclusion Criteria Thoracoscopic surgery candidate. Over 18 years old. No known allergy to Bupivacaine. Patient is able to read understand and singe an inform consent.
Exclusion Criteria Previous thoracic operation in the same side.
Study plan The study cohort will be divided into two groups. Study group and control group. Each group will include 30 thoracoscopic surgery candidates. The participants will be randomly assigned to the research groups using a computer selection done by the study team. The participants will not know as to which group they are assigned. All participants will by recruited in the cardio-thoracic surgery department, CARMEL medical center, Haifa, ISRAEL.
The basic thoracoscopic surgery approach uses three operation cuts the main Lateral surgical cut is less than 5 cm. Another lower cut of 1-2cmfor the video camera and a lateral subscapular cut of 1-2cm for lung retraction. No rib retractors are being used.
During surgery the anesthesiology team is in charge of patient sedation and analgesia according to the local anesthesia department protocol.
After surgery the thoracic team is in charge on patient analgesia treatment according to cardio-thoracic surgery department local protocol.
Patients will randomized into either study or control group. In the study group the surgeon will perform an intercostal Bupivacaine block of 100ml over five intercostal spaces which include the operation cuts. The block will be done in the beginning of the surgery right after the insertion of the video camera to the pleural space. In the control group the surgeon will perform the same intercostal block at the end of the surgery just before closing the operation cuts. All other operation stapes and analgesic treatment will be the same for both groups.
Follow up Patient follow up will include the perioperative hospitalization and will continue up to six months after discharge.
Follow up will include analgesic medication usage, pain levels, demographic details, Hospital length of stay, post-operative complication and time to resume daily routine.
- Conditions
- Chest Pain, Surgery
- Being tested
- Intercostal block Bupivacaine based
- Keywords
- Post surgical pain
- Medical subject headings
- Chest Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intercostal block Bupivacaine basedOther
Intercostal Bupivacaine block of 100ml over five intercostal spaces.
| Study group | Role | What they receive |
|---|---|---|
| study | Experimental | In the study group the surgeon will perform an intercostal Bupivacaine block of 100ml over five intercostal spaces which include the operation cuts. The block will be done in the beginning of the surgery right after the insertion of the video camera to the pleural space. Receives: Other: Intercostal block Bupivacaine based |
| control | Other | In the control group the surgeon will perform the same intercostal block at the end of the surgery just before closing the operation cuts. this approach is used today in our department. Receives: Other: Intercostal block Bupivacaine based |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic Use
The amount of analgesic medication consumption by patients during and after thoracoscopic surgery. the measurement include A. Analgesic usage during the hours of operation and recovery unit (4-8Hr) B. Analgesic usage during postoperative days (first, second, third and fourth for each 24 Hr)
Measured: post operative
Secondary outcomes (1)
Visual Analog Pain Scale
subjective patient's pain evaluation according to Visual Analog pain Scale (VAS). Visual Analog pain Scale a 1-10 score of pain. 1 being a lowest level of pain and 10 the worst pain felt by the patient.
Measured: post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startJun 2015
- Primary completion30 Jan 2017
- Study completion25 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Levy Faber, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469610
- Sponsor's protocol ID
- CMC-14-0123-CTIL
- Status last verified
- Apr 2019
- First submitted
- 9 Jun 2015
- Last updated
- 5 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: general discricptive data only
Publications
1. Regional analgesia for video-assisted thoracic surgery: a systematic review.Steinthorsdottir KJ, Wildgaard L, Hansen HJ, Petersen RH, Wildgaard K. Eur J Cardiothorac Surg. 2013 Nov 27. 2. Postoperative analgesia in video-assisted thoracoscopy: the role of intercostal blockade. Taylor R, Massey S, Stuart-Smith K. J Cardiothorac Vasc Anesth. 2004 Jun;18(3):317-21. 3. The efficacy of intraoperative internal intercostal nerve block during video-assisted thoracic surgery on postoperative pain.Bolotin G, Lazarovici H, Uretzky G, Zlotnick AY, Tamir A, Saute M.Ann Thorac Surg. 2000 Dec;70(6):1872-5. 4. Preventing post-thoracotomy pain syndrome.Khelemsky Y, Noto CJ. Mt Sinai J Med. 2012 Jan-Feb;79(1):133-9. doi: 10.1002/msj.21286. Review. 5. Prevention of chronic pain after surgical nerve injury: amputation and thoracotomy.Buchheit T, Pyati S.Surg Clin North Am. 2012 Apr;92(2):393-407. Review. 6. Paravertebral blocks.Chelly JE. Anesthesiol Clin. 2012 Mar;30(1):75-90. Review. 7. Persistent postoperative pain: where are we now? Niraj G, Rowbotham DJ. Br J Anaesth. 2011 Jul;107(1):25-9. Review.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Intercostal Block Scheduling in Preventing Acute Surgical and Post-surgical Pain in Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT02469610
- Acronym / sponsor ID
- CMC-14-0123-CTIL
- Conditions
- Chest Pain, Surgery
- Keywords
- Post surgical pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- 30 Jan 2017 (actual)
- Study completion
- 25 Jun 2017 (actual)
- First posted
- 11 Jun 2015 (estimated)
- Results
- Posted 5 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is well known that chest surgery patients suffer from high level pain in the perioperative period. The transition to thoracoscopic approaches reduced surgical pain. The proper pain control technique for thoracoscopic approaches is still under debate. One of the most popular methods for pain control is these procedures is the Intercostal block. The Intercostal block is usually based upon topical analgesic. In this study the investigators will try to examine the effect on pain control of the timing of Intercostal block of 100 mg BUPIVACAINE. The study is a prospective comparative study. The cohort will be divided into two groups. In the control group patients will have Intercostal block after surgery and in the study group the intercostal block will be given in the beginning of the surgical procedure. All other analgesic treatment during and post-surgery will be the same in both groups. The study will evaluate pain level in the days after the surgery, analgesic medication consumption and relevant morbidity.
Detailed description
Intercostal Bupivacaine block Intercostal block is a procedure during which a local anesthetic is injected to the intercostal space. This space includes the rote of the intercostal nerve. The purpose of the procedure is to block the neuropathic pain that developed due to inflammation and irritation of the nerve and other close structures. Some add steroids to the injection because of their anti-inflammatory effect.
Bupivacaine is a local anesthetic. It belongs to a group of medicines called amide- type local anesthetics. It is a well-known medication with many years of documented use in local and regional anesthesia. Bupivacaine binds to the intracellular portion of voltage-gated sodium channels and blocks sodium influx into nerve cells. This block prevents depolarization. The lack of depolarization precludes initiation or conduction of a pain signal can occur.
Study Aims This study will try to evaluate the difference in pain control during and post thoracoscopic surgery in patients who had bupivacaine intercostal block before versus after surgery.
The study main end point is the amount of analgesic medication consumption by patients during and after thoracoscopic surgery.
Secondary end points will include subjective patient's pain evaluation, length of hospital stay and post-operative complication.
Inclusion Criteria Thoracoscopic surgery candidate. Over 18 years old. No known allergy to Bupivacaine. Patient is able to read understand and singe an inform consent.
Exclusion Criteria Previous thoracic operation in the same side.
Study plan The study cohort will be divided into two groups. Study group and control group. Each group will include 30 thoracoscopic surgery candidates. The participants will be randomly assigned to the research groups using a computer selection done by the study team. The participants will not know as to which group they are assigned. All participants will by recruited in the cardio-thoracic surgery department, CARMEL medical center, Haifa, ISRAEL.
The basic thoracoscopic surgery approach uses three operation cuts the main Lateral surgical cut is less than 5 cm. Another lower cut of 1-2cmfor the video camera and a lateral subscapular cut of 1-2cm for lung retraction. No rib retractors are being used.
During surgery the anesthesiology team is in charge of patient sedation and analgesia according to the local anesthesia department protocol.
After surgery the thoracic team is in charge on patient analgesia treatment according to cardio-thoracic surgery department local protocol.
Patients will randomized into either study or control group. In the study group the surgeon will perform an intercostal Bupivacaine block of 100ml over five intercostal spaces which include the operation cuts. The block will be done in the beginning of the surgery right after the insertion of the video camera to the pleural space. In the control group the surgeon will perform the same intercostal block at the end of the surgery just before closing the operation cuts. All other operation stapes and analgesic treatment will be the same for both groups.
Follow up Patient follow up will include the perioperative hospitalization and will continue up to six months after discharge.
Follow up will include analgesic medication usage, pain levels, demographic details, Hospital length of stay, post-operative complication and time to resume daily routine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study | Experimental | Other: Intercostal block Bupivacaine basedIn the study group the surgeon will perform an intercostal Bupivacaine block of 100ml over five intercostal spaces which include the operation cuts. The block will be done in the beginning of the surgery right after the insertion of the video camera to the pleural space. |
| control | Other | Other: Intercostal block Bupivacaine basedIn the control group the surgeon will perform the same intercostal block at the end of the surgery just before closing the operation cuts. this approach is used today in our department. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Thoracoscopic surgery candidate.
- Over 18 years old.
- No known allergy to Bupivacaine.
- Patient is able to read understand and singe an inform consent.
Key exclusion criteria (1 listed)
- Previous thoracic operation in the same side.
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 |
|---|---|---|
| Intercostal block Bupivacaine basedIntercostal Bupivacaine block of 100ml over five intercostal spaces. | Other | control, study |
Primary outcome
Analgesic Use
Time frame: post operative
The amount of analgesic medication consumption by patients during and after thoracoscopic surgery. the measurement include A. Analgesic usage during the hours of operation and recovery unit (4-8Hr) B. Analgesic usage during postoperative days (first, second, third and fourth for each 24 Hr)
1 secondary outcome
Visual Analog Pain Scale
Time frame: post operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background1. Regional analgesia for video-assisted thoracic surgery: a systematic review.Steinthorsdottir KJ, Wildgaard L, Hansen HJ, Petersen RH, Wildgaard K. Eur J Cardiothorac Surg. 2013 Nov 27. 2. Postoperative analgesia in video-assisted thoracoscopy: the role of intercostal blockade. Taylor R, Massey S, Stuart-Smith K. J Cardiothorac Vasc Anesth. 2004 Jun;18(3):317-21. 3. The efficacy of intraoperative internal intercostal nerve block during video-assisted thoracic surgery on postoperative pain.Bolotin G, Lazarovici H, Uretzky G, Zlotnick AY, Tamir A, Saute M.Ann Thorac Surg. 2000 Dec;70(6):1872-5. 4. Preventing post-thoracotomy pain syndrome.Khelemsky Y, Noto CJ. Mt Sinai J Med. 2012 Jan-Feb;79(1):133-9. doi: 10.1002/msj.21286. Review. 5. Prevention of chronic pain after surgical nerve injury: amputation and thoracotomy.Buchheit T, Pyati S.Surg Clin North Am. 2012 Apr;92(2):393-407. Review. 6. Paravertebral blocks.Chelly JE. Anesthesiol Clin. 2012 Mar;30(1):75-90. Review. 7. Persistent postoperative pain: where are we now? Niraj G, Rowbotham DJ. Br J Anaesth. 2011 Jul;107(1):25-9. Review.
- Individual participant dataSharing planned: Undecided. general discricptive data only
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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 Intercostal block Bupivacaine based in people with Chest Pain and Surgery, run by Carmel Medical Center at 1 site in Israel.
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 1 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 5 Jul 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 Israel. 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?
Yes. Results are posted in the registry (first posted 5 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Analgesic Use (time frame: post operative). 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 NCT02469610, which also lists 1 linked publication.
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 5 Jul 2019.