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Paravertebral Calcitonin in Thoracotomy

Plain-language guide to NCT06330168: not phased randomized trial of Calcitonin, 92 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06330168
Phase
not phased
Status
completed
Start
2024-03-28
Completion (planned or actual)
2025-05-14
Participants
92 (actual)
Design
randomized, triple-blind, prevention
Conditions studied
Calcitonin; Paravertebral; Thoracotomy
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Calcitonin.

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.

It had two arms (groups): bupivacaine-calcitonin-fentanyl group (experimental) and bupivacaine-fentanyl group (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Single-shot thoracic paravertebral block combined with intravenous analgesia is one of the regional techniques used for controlling pain in patients undergoing thoracic surgery.

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.

Who Took Part

92 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Aged ≥ 18 years. American society of anesthesiology (ASA) physical status of I-III. Scheduled for elective thoracotomy.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: contraindication to thoracic paravertebral block as coagulopathy or local anesthetic allergy; history of cardiovascular and gastro-esophageal surgery; preexisting pain syndrome or psychological disorders.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the Calcitonin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Calcitonin.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2024-03-28 with completion listed for 2025-05-14.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): morphine consumption (time frame: from the end of surgery until the end of the first postoperative day). Incidence of chronic pain at 3 months after surgery (time frame: 3 months after surgery).

It also tracked 5 secondary outcomes, for example numerical rating scale scores, incidence of chronic pain, Side effects, Intensity of chronic pain and morphine consumption.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Calcitonin in 92 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Calcitonin compound page, all human trials.

Our Notes on the Compound

Calcitonin: A 32-amino-acid hormone that lowers blood calcium; salmon calcitonin (Miacalcin) has been used for Paget disease and osteoporosis.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.