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Comparative study of different therapeutic modalities for controlling postoperative pain in proximal femur surgery

Comparative study between pericapsular nerve block (PENG BLOCK) associated with the lateral femoral cutaneous nerve, iliac fascia block and intrathecal morphine in postoperative pain after proximal femur surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3q6jfwp
Enrollment
Unknown
Registered
2025-01-14
Start date
2025-02-01
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

Acute pain

Interventions

This is a two-arm, double-blind, randomized controlled clinical trial. Research location: Surgical Center of the Getúlio Vargas State Hospital.Population sample: As this is a pilot study, the sample s
group 2: 30
group 3: 30. Total: 90 participants.The research participants, candidates for fracture surgeries of the proximal end of the femur (osteosynthesis), after applying the inclusion and exclusion criteria,
Group 2: Bcfis
Group 3: Bncfl + Peng.The research participants in group 1 will receive Bcfis with 30 mL of saline solution, in addition to Bncfl and Peng block, with 20 ml and 10 ml of saline solution guided by USG

Sponsors

Secretaria Estadual de Saúde - RJ
Lead Sponsor
Secretaria Estadual de Saúde - RJ
Collaborator
Comitê de Ética em Pesquisa
Collaborator

Eligibility

Age
19 Years to No maximum

Inclusion criteria

Inclusion criteria: Participants over 18 years of age; of both sexes; undergoing surgery to correct a fracture of the proximal end of the femur

Exclusion criteria

Exclusion criteria: Allergy or intolerance to any of the drugs used in the study; liver failure; estimated glomerular filtration rate < 15 mL/min/1.73 m2; known or suspected coagulopathy; pre-existing neurological or anatomical deficits in the lower extremities; cognitive impairment with difficulties in assessing pain and severe psychiatric illness; chemical dependency; history of mental illness; hemoglobin less than 9 mg/dl; conversion of spinal anesthesia to general anesthesia; blood transfusion; duration of surgery longer than 3 hours; change of surgical plan or orthopedic complication during surgery

Design outcomes

Primary

MeasureTime frame
To evaluate whether the association between BNCFL and PENG block promotes postoperative analgesia to movement equivalent to or superior to SIFIB and MORFIT, in fractures of the proximal end of the femur. For this, pain on movement will be measured at 6, 12 and 24, 30, 36, 42 and 48 hours after the procedure.The group (BNCFL and PENG block) is expected to present analgesic quality superior to or equivalent to that of the SFIB and MORFIT groups (the latter considered the standard), but with a lower incidence of impairment of motor function and other adverse effects.

Secondary

MeasureTime frame
Measure pain at rest, assess quadriceps motor function using dynamometry and strength index, compare the total dose of opioids consumed in 24 hours and the incidence of their side effects. ;The time of the first request for these will also be recorded, as well as the incidence of complications from the blocks, postoperative delirium and length of hospital stay.

Countries

Brazil

Contacts

Public ContactComitê de Ética em Pesquisa

Faculdade de Medicina da Universidade Federal Fluminense - FMUFF

etica.ret@id.uff.br+55(21)2629-9310

Outcome results

None listed

Source: REBEC (via WHO ICTRP)