Is magnesium sulfate an alternative with an analgesic and safety profile equivalent to dexmedetomidine as an adjuvant to ropivacaine in erector block in mastectomy?

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

26 Jan 2026 → ongoing

Decision date (initial)

2025-11-03

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Hospital Universitario de La Plana · Fundación FISABIO

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

The main objective of this study is to determine whether magnesium sulfate as an adjuvant to 0.3% ropivacaine in erector spinae plane (ESP) blockade in mastectomy surgery offers an analgesic profile comparable to that of dexmedetomidine in terms of duration of postoperative analgesia based on the interval between recovery from general anesthesia and the time of the first request for rescue analgesia.

Secondary objectives 6

1. • Assess postoperative pain intensity using the visual analog scale (VAS) at specific time points.
2. • Total rescue analgesia consumption.
3. • Compare the incidence of postoperative sedation using the Ramsay Sedation Scale.
4. • Assess the incidence of adverse effects (nausea, vomiting, and complications related to the block).
5. • Compare hemodynamic parameters (heart rate (HR) and mean arterial pressure (MAP)) to assess the incidence of bradycardia and hypotension.
6. • Assess patient satisfaction.

Conditions and MedDRA coding

Breast cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. • Patients aged 18 to 75 years scheduled for elective mastectomy under general anesthesia
2. • ASA I-III patients
3. • No contraindications for locoregional anesthesia

Exclusion criteria 10

1. • Allergy to study drugs or local anesthetics.
2. • Body mass index (BMI) > 35 kg/m².
3. • Coagulopathy or bleeding disorder.
4. • Pre-existing bradycardia or cardiac conduction block.
5. • Psychiatric illness.
6. • Pregnancy.
7. • Injection site infection.
8. • Patients receiving α-adrenergic agonists or antiplatelet agents.
9. • Chronic opioid use.
10. • Uncooperative patients.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Time in minutes between recovery from general anesthesia and the moment the patient requests the first rescue analgesia

Secondary endpoints 5

1. total amount of rescue analgesic consumed in the postoperative period during the first 24 hours.
2. Pain level using the validated Visual Analog Scale (VAS) (0 = no pain, 10 = maximum imaginable pain). VAS scores will be recorded at time 0, which is when the patient arrives at the PACU, and subsequently at 2, 4, 8, 10, and 24 hours.
3. heart rate (HR) and mean arterial pressure (MAP)
4. incidence of adverse effects such as nausea, vomiting, bradycardia (HR < 60 bpm), hypotension (SBP < 90 mmHg or < 20% of baseline), respiratory depression, pruritus, and any complications related to the block (e.g., vascular puncture, nerve damage, pneumothorax, local anesthetic toxicity).
5. Patient satisfaction with postoperative pain management will be assessed using a satisfaction scale of 0 to 100 points (0 = Very dissatisfied with the analgesia provided by the treatment and 100 = totally satisfied with the analgesia provided by the treatment).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana

Sponsor organisation

Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana

Address

Avenida Cataluna 21

City

Valencia

Postcode

46020

Country

Spain

Scientific contact point

Organisation

Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana

Contact name

Maria Angeles Darás Orenga

Public contact point

Organisation

Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana

Contact name

Maria Angeles Darás Orenga

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications