Femoral Preincisional Block in Acute Postoperative Pain Management of Surgery Orthopaedic Lower Limb

Surgery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02239497
• Other study ID #: Femoral Block
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2014
• Last updated: September 10, 2014
• Start date: March 2013

Study information

• Verified date: September 2014
• Source: Hospital Central Dr. Luis Ortega
• Contact: n/a
• Is FDA regulated: No
• Health authority: Venezuela: Instituto Venezolano de Los Seguros Sociales
• Study type: Interventional

Clinical Trial Summary

Proper management of acute postoperative pain (DAPO) is essential for the recovery of orthopedic surgeries. The blockade of the femoral nerve preincisional (BFP) is simple and its effectiveness increases guided by ultrasound and neurostimulation. OBJECTIVE: To evaluate the effectiveness of BFP in patients undergoing orthopedic surgery of the lower limbs under general anesthesia. METHODS: A comparative study was conducted, randomized, two groups, surgeries of the hip, femur and knee, ASA I-II, aged 18 years. Group B (n = 15) received BFP and ultrasound-guided nerve stimulation with 20 ml of bupivacaine 0.5% plus epinephrine 1: 200,000. Group S (n = 15) without blocking. Both groups received intravenous analgesia with ketoprofen 100 mg regimen and dipyrone 1g c / 8 hs and balanced general anesthesia. Postoperative morphine 0.03 mgr / kgr / weight was administered if EVA ≥4

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ASA I and II patients, both sexes, plan for elective orthopaedic surgery of the lower limbs (femur and knee) under general anesthesia

Exclusion Criteria:

• Patients with any anesthetic or surgical complication

• Patients with neuromuscular diseases

• Allergy to any of the drugs used in the study

• Inability to understand and use a pain scale

• Also those patients in whom it was not possible to locate anatomical landmarks and / or failed femoral block

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Surgery

Intervention

Procedure:
• Femoral block by ultrasound and neurostimulation

Drug:
• Intravenous analgesia
Intravenous analgesia with ketoprofen, dipyrone and dexamethasone. IV morphine to rescue analgesia

Locations

Country	Name	City	State
Venezuela	Servicio de Anestesiologia Hospital "Dr. Luis Ortega"	Porlamar	Estado Nueva Esparta

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Central Dr. Luis Ortega

Country where clinical trial is conducted

Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperatory EVA values and need for rescue analgesia with IV morphine		24 hours	Yes