Paravertebral Calcitonin in Thoracotomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-28

Study Completion Date

2026-02-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Calcitonin Paravertebral Thoracotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

triple

Study Groups

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bupivacaine-calcitonin-fentanyl group

thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 100 IU of calcitonin (1ml)

Group Type EXPERIMENTAL

bupivacaine-calcitonin-fentanyl

Intervention Type 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).

bupivacaine-fentanyl group

thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 1 ml saline 0.9%.

Group Type PLACEBO_COMPARATOR

Bupivacaine-fentanyl

Intervention Type 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%.

Interventions

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bupivacaine-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).

Intervention Type DRUG

Bupivacaine-fentanyl

pre-induction single shot thoracic paravertebral block using 20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml), and 1 ml saline 0.9%.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No