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

NCT02239497 | Completed Phase 4

• 1 other identifier: Femoral Block
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Surgery

Keywords

postoperatory pain; orthopaedic surgery; femoral block

Outcome Measures

Primary Outcomes (1)

• Postoperatory EVA values and need for rescue analgesia with IV morphine

  24 hours

Study Arms (2)

femoral block by US and NE and intravenous analgesia

EXPERIMENTAL

preincisional femoral block by ultrasound and neurostimulation, with 20 ml bupivacaine 0,5% and epinephrine. ketoprofen, dipyrone and dexamethasone IV. Morphine IV to rescue analgesia

Procedure: Femoral block by ultrasound and neurostimulation; Drug: Intravenous analgesia

Intravenous analgesia

EXPERIMENTAL

Intravenous analgesia with ketoprofen, dipyrone and morphine. IV morphine to rescue analgesia

Drug: Intravenous analgesia

Interventions

Femoral block by ultrasound and neurostimulation PROCEDURE

femoral block by US and NE and intravenous analgesia

Intravenous analgesia DRUG

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

Intravenous analgesia; femoral block by US and NE and intravenous analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Central Dr. Luis Ortega: lead

Study Sites (1)

Servicio de Anestesiologia Hospital "Dr. Luis Ortega"

Porlamar, Nueva Esparta, 6301, Venezuela

Location

Study Officials

• Beatriz S Arismendi Gomez, MD

  Hospital "Dr Luis Ortega"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: September 7, 2014
• First Posted: September 12, 2014
• Study Start: March 1, 2013
• Primary Completion: September 1, 2013
• Last Updated: September 12, 2014

Record last verified: 2014-09

Locations

VE (1)