Calcitonin, Paravertebral, Thoracotomy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGbupivacaine-calcitonin-fentanyl
pre-induction single shot thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 100 IU of calcitonin (1ml).
pre-induction single shot thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 1 ml saline 0.9%.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
triple
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* aged ≥ 18 years * American society of anesthesiology (ASA) physical status of I-III * scheduled for elective thoracotomy
Exclusion criteria
* Contraindication to thoracic paravertebral block as coagulopathy or local anesthetic allergy. * Pregnancy * History of cardiovascular and gastro-esophageal surgery * Preexisting pain syndrome or psychological disorders * Severe hepatic, cardiovascular, or renal disorders * Allergy to calcitonin * Patients who will be re-operated and who will report infections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| morphine consumption | from the end of surgery until the end of the first postoperative day | Total morphine dose consumed in the first 24 hour after surgery |
| Incidence of chronic pain at 3 months after surgery | 3 months after surgery | chronic pain at 3 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| numerical rating scale scores | from arrival to the post-anesthesia care unit until 48 hour after surgery. | 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 |
| incidence of chronic pain | 12 months after surgery | chronic pain at 6, 9, and 12 months after surgery |
| Side effects | first postoperative day | hypotension, postoperative nausea and vomiting |
| Intensity of chronic pain | 12 months after surgery | 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) |
| morphine consumption | 48 hours after surgery | Total morphine dose consumed during the second postoperative day |
Countries
Egypt
Outcome results
None listed