Skip to content

Use of corticoid associated with local anesthetic in anesthesia technique for video-assisted shoulder surgery

Prolongation of sensory block with the combination of Dexamethasone and Levobupivacaine in the brachial plexus block for shoulder arthroscopy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-5yv2xr
Enrollment
Unknown
Registered
2019-06-05
Start date
2017-01-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Injuries

Interventions

All patients will undergo the same procedures for monitoring, induction and maintenance of general anesthesia. It will require 74 patients in total divided into two groups: study and control. Experime
Drug
D26.660

Sponsors

Financiamento próprio.
Lead Sponsor
Financiamento próprio.
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Adult patients; age between 18 and 65 years; physical status 1 and 2 of the American Society of Anesthesiology (ASA P1 and P2); body mass index (BMI) <30 kg / m2; both sexes; submitted to shoulder arthroscopy for treatment of rotator cuff rupture.

Exclusion criteria

Exclusion criteria: Puncture site skin infection; coagulopathy; brachial plexus neuropathy; systemic use of corticosteroids; routine use of opioids; diabetes; severe lung disease; psychiatric illness; and intolerance to one or more study medications.

Design outcomes

Primary

MeasureTime frame
- Duration of the sensitive block (minutes). The patients were evaluated in 4 moments postoperatively: in the PACU (post-anesthetic recovery room), 4, 12 and 24 hours after the procedure, when the patient was discharged. The duration of the sensory blockade (in minutes) was evaluated by means of a test with cotton soaked in alcoholic solution. The sensation of touch or temperature in the shoulder region was questioned and in case of a positive response in at least one of the two, it was considered to be the end of the sensory blockade. If they had presented pain complaints during the evaluation interval, this moment was considered as the end of the sensory blockade. The end of the injection of the local anesthetic solution was considered the zero moment to evaluate the duration of the blockade. An extension of at least 50% of the duration of the sensory blockade was expected according to previous studies.

Secondary

MeasureTime frame
- Intensity of pain Evaluated by visual analog pain scale (VAS). The patients were evaluated in 4 moments postoperatively: in the PACU (post-anesthetic recovery room), 4, 12 and 24 hours after the procedure, when the patient was discharged. A reduction of at least 30% in pain scores is considered satisfactory.;- Need for rescue analgesia in the first 24 hours. Evaluated as a dichotomous variable (yes / no). The patients were evaluated in 4 moments postoperatively: in the PACU (post-anesthetic recovery room), 4, 12 and 24 hours after the procedure, when the patient was discharged. Reduction of at least 30% is considered satisfactory.;- Incidence of postoperative nausea and vomiting (PONV) Evaluated as a dichotomous variable (yes / no). The patients were evaluated in 4 moments postoperatively: in the PACU (post-anesthetic recovery room), 4, 12 and 24 hours after the procedure, when the patient was discharged. Reduction of at least 10% is considered satisfactory.;- Block failure index. Evaluated as a dichotomous variable (yes / no). Characterized as an unaltered pain or sensory complaint in the limb operated in the anesthetic recovery room. The absence of failure is expected.

Countries

Brazil

Contacts

Public ContactJoão Paulo Jordão Pontes

Complexo Hospitalar Santa Genoveva

pontes_ufu@yahoo.com.br+55-034-991339765

Outcome results

None listed

Source: REBEC (via WHO ICTRP)