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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intercostal block Bupivacaine based | Other | Intercostal Bupivacaine block of 100ml over five intercostal spaces. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | post operative |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | post operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CarmelMC | Haifa | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. |
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general discricptive data only
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| ID | Title | Description |
|---|---|---|
| FG000 | Study | 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. Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces. |
| FG001 | Control | 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. Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study | 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. Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | the use of opioids in the operative day (post operative day 0) | Posted | Mean | Standard Deviation | MG | post operative |
|
1 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study | 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. Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| massive pulmonary emboli | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr LEVY FABER Dan | CarmelMC | 97248250289 | DANLf@clalit.org.il |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 28, 2016 | Apr 14, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 1, 2016 | Apr 14, 2019 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 1, 2014 | Apr 14, 2019 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D002637 | Chest Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| exclusion criteria |
|
| BG001 | Control | 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. Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Control |
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. Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces. |
|
|
| Secondary | 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. | Visual Analog pain Scale on the first post-operative day. For each patient we calculate the average score of his answers to the question "How do you rate your pain on the Visual Analog pain Scale ?" during the first post-operative day. | Posted | Mean | Standard Deviation | units on a scale | post operative |
|
|
|
| 1 |
| 34 |
| 1 |
| 34 |
| 0 |
| 34 |
| EG001 | Control | 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. Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces. | 0 | 31 | 0 | 31 | 0 | 31 |
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| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |