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Comparison between spinal morphine and nerve block for pain after ankle surgery: clinical study

Evaluation of intrathecal morphine vs. sciatic and saphenous nerve block with or without adjuvants in postoperative analgesia for ankle fracture: a randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-2rhpn6x
Enrollment
Unknown
Registered
2024-08-20
Start date
2024-07-08
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

Ankle Fractures

Interventions

This is a randomized and blinded study. The sample size was calculated a priori using G Power software three point one from Christian Albrechts University in Kiel Germany. Since there are no studies u

Sponsors

Hospital Getúlio Vargas
Lead Sponsor
Hospital Getúlio Vargas
Collaborator

Eligibility

Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients of both genders; who agree to participate in the study and sign the Free and Informed Consent Form ICF; aged eighteen years or older and younger than sixty five years; with a physical status classification of one to three according to the American Society of Anesthesiologists ASA; undergoing spinal anesthesia for ankle level surgeries

Exclusion criteria

Exclusion criteria: Refusal to participate in the research; difficulty in understanding the visual analog scale for pain; chronic use of analgesics and or contraindication to the use of nonsteroidal anti inflammatory drugs NSAIDs; body weight less than fifty kilograms to avoid toxic doses of local anesthetics; pregnant women; patients known to be allergic to local anesthetics and analgesics; those with an infection at the needle insertion site; coagulopathy; presence of neuropathy or neurological dysfunction in the lower extremities; and technical difficulties that do not allow for a block considered satisfactory by the technique described in this study

Design outcomes

Primary

MeasureTime frame
It is expected that patients undergoing peripheral nerve blocks with the addition of adjuvants (dexamethasone and epinephrine) will have significantly lower postoperative pain scores compared to the others.

Secondary

MeasureTime frame
It is expected that the incidence of nausea, vomiting, itching, and the need for rescue opioids will be significantly higher in the group receiving intrathecal morphine as the analgesic technique.

Countries

Brazil

Contacts

Public ContactAlexandre Júnior

Hospital Getúlio Vargas

alexandre_luna_junior@hotmail.com+55 (81) 31845600

Outcome results

None listed

Source: REBEC (via WHO ICTRP)