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This prospective randomized double-blinded controlled study will be conducted to evaluate the effect of adding calcitonin to bupivacaine in thoracic paravertebral block for patients undergoing thoracotomy.
Single-shot thoracic paravertebral block combined with intravenous analgesia is one of the regional techniques used for controlling pain in patients undergoing thoracic surgery. However, few articles demonstrated its effects on acute pain and chronic pain after thoracotomy and revealed high postoperative opioid consumption and inability to reduce the incidence of chronic pain.
Calcitonin has previously been shown to be effective in the management of acute pain following amputation, vertebral fractures and other neuropathic conditions.
Using calcitonin as an additive in thoracic paravertebral block was not evaluated in previous studies, investigators conducted this study based on the hypothesis that calcitonin use as an additive in thoracic paravertebral block for patients undergoing thoracotomy may have extended analgesic effects regarding decreasing postoperative pain scores, opioid consumption, and this value may decrease the incidence of chronic post-thoracotomy pain.
In both groups, ultrasound-guided thoracic paravertebral block will be performed before anesthetic induction using a high-frequency linear probe after identifying the paravertebral space of the proposed level of intercostal skin incision.General anesthesia in both groups will be similar.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bupivacaine-calcitonin-fentanyl group | Experimental | thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 100 IU of calcitonin (1ml) |
|
| bupivacaine-fentanyl group | Placebo Comparator | thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 1 ml saline 0.9%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bupivacaine-calcitonin-fentanyl | Drug | pre-induction single shot thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 100 IU of calcitonin (1ml). |
| Measure | Description | Time Frame |
|---|---|---|
| morphine consumption | Total morphine dose consumed in the first 24 hour after surgery | from the end of surgery until the end of the first postoperative day |
| Incidence of chronic pain at 3 months after surgery | chronic pain at 3 months after surgery | 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| numerical rating scale scores | A 0-10 numerical rating scale ( 0 means no pain and 10 means the worst pain) at coughing and at rest will be assessed by an investigator during the first and second day post operation | from arrival to the post-anesthesia care unit until 48 hour after surgery. |
| incidence of chronic pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University Hospitals | Tanta | Gharbia Governorate | 31527 | Egypt |
The data will be available upon reasonable request from the corresponding author
After completion of the study
The data will be available upon reasonable request from the corresponding author
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triple
| Bupivacaine-fentanyl | Drug | pre-induction single shot thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 1 ml saline 0.9%. |
|
chronic pain at 6, 9, and 12 months after surgery |
| 12 months after surgery |
| Side effects | hypotension, postoperative nausea and vomiting | first postoperative day |
| Intensity of chronic pain | Chronic pain intensity will be assessed at 3, 6, 9, and 12 months after surgery using A 0-10 numerical rating scale (0 means no pain and 10 means the worst pain) | 12 months after surgery |
| morphine consumption | Total morphine dose consumed during the second postoperative day | 48 hours after surgery |