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Effect of a Sciatic Block (SNB) Combined With a Continuous Femoral Block (CFNB) on Pain Scores After Knee Arthroplasty

This study has been completed.
Sponsor:
Collaborator:
Universidade do Porto
Information provided by (Responsible Party):
Raul Carvalho, Centro Hospitalar do Porto
ClinicalTrials.gov Identifier:
NCT01337115
First received: April 15, 2011
Last updated: May 17, 2012
Last verified: May 2012
History of Changes
  Purpose

The purpose of this study is to determine if the addition of a sciatic nerve block (SNB) to a continuous femoral nerve block (CFNB) improves post-operative analgesia after knee arthroplasty.


Condition Intervention
Postoperative Pain
 Procedure: SNB plus CFNB
Procedure: CFNB

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of a Single Shot Sciatic Nerve Block (SNB) Combined With a Continuous Femoral Block (CFNB) on Pain Scores After Knee Arthroplasty. A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Further study details as provided by Centro Hospitalar do Porto:

Primary Outcome Measures:
  • Visual Analogue Scores (VAS) - Pain Scores Measured in mm (0-100) [ Time Frame: 15-30 min after arrival on post anesthesia care unit (PACU) ] [ Designated as safety issue: No ]
    Pain scores measured by Visual Analogue Score (VAS) scale at 15-30min after Post anesthesia care unit (PACU) arrival VAS is a 100mm scale to measure pain. 0mm - no pain 100mm - worst possible pain

  • VAS Results - Pain Measured in mm (0-100) [ Time Frame: 12h after surgery ] [ Designated as safety issue: No ]

    VAS pain scores are measured by blinded investigators 12h after surgery .

    VAS scale:

    0 - no pain 100 - worst possible pain


  • VAS Results - Pain Scores Measured in mm (0-100) [ Time Frame: 24h after surgery ] [ Designated as safety issue: No ]

    VAS pain scores are measured by blinded investigators 24h after surgery .

    VAS scale:

    0 - no pain 100 - worst possible pain



Secondary Outcome Measures:
  • Satisfaction With Anesthesia Technique in Each Arm of the Study [ Time Frame: 1 month after surgery ] [ Designated as safety issue: No ]

    Satisfaction with the anesthesia technique using a categorical scale with three levels:

    Bad Reasonable Good/Very Good A Fisher's Exact test is made to asses any differences in the distribution of patients in each arm to each level of the categorical scale



Enrollment: 50
Study Start Date: April 2011
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Continuous femoral nerve block (CFNB)
A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before induction of general anesthesia and surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in post anesthesia care unit (PACU) and maintained for 48h
 Procedure: CFNB
A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before induction of general anesthesia and surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in post anesthesia care unit (PACU) and maintained for 48h
Other Names:
  • Peripheral nerve blocks
  • Local anesthetics
  • Ropivacaine
  • Femoral nerve block
Experimental: Single shot SNB plus CFNB
A single shot sciatic nerve block (SNB) is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block (CFNB) performed in the control group before induction of general anesthesia and surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in Post anesthesia care unit (PACU) and maintained for 48h
 Procedure: SNB plus CFNB
A single shot sciatic nerve block (SNB) is performed with 25 ml of 0.2% ropivacaine before surgery in addition to an isolated continuous femoral nerve block (CFNB) in the control group
Other Names:
  • Peripheral nerve blocks
  • Local anesthetics
  • Ropivacaine
  • Femoral nerve block
  • Sciatic nerve block

Detailed Description:

Background: Postoperative pain after total knee replacement /arthroplasty (TKA) is a major concern. It is severe pain in 60% of patients and moderate in 30%. Continuous femoral nerve blocks (CFNB) are considered an excellent choice for regional anesthesia for major knee repair but there are some controversies about the need of supplemental obturator or sciatic nerve blocks for achieving better postoperative analgesia. A recent meta-analysis states there is no sufficient evidence to recommend or discharge these associations.

Objectives: We aim to assess the efficacy of the association of a sciatic nerve block (SNB) and a continuous femoral nerve block (CFNB) for reducing postoperative pain in patients submitted to TKA. Methods: A randomized controlled study on 50 patients submitted to TKA. Control group receives a femoral nerve block with a catheter before general anesthesia is induced and the intervention group gets a similar block plus a single shot SNB before general anesthesia. Both groups start a continuous local anesthetic infusion through femoral catheter after the end of surgery and supplemental oral diclofenac and paracetamol. Pain scores are measured until 24h postoperatively, side effects and patient satisfaction are monitored.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unilateral total knee replacement

Exclusion Criteria:

  • Contra-indication for general anesthesia
  • Infection on puncture site
  • Coagulation disorders
  • Pre-existent neuropathies
  • Allergies to local anesthetics, paracetamol, diclofenac and tramadol
  • Severe dyspepsia
  • Less than 50kg weigh
  • Body Mass Index (BMI) greater than 40
  • American Society of Anesthesiologists (ASA) Physical Status 4 or 5
  • Absence of capacity to use the Visual Analog Score (VAS) scale
  • Refusal to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337115

Locations
Portugal
Centro Hospitalar do Porto, Serviço de Anestesia
Porto, Portugal, 4099-001
Sponsors and Collaborators
Centro Hospitalar do Porto
Universidade do Porto
Investigators
Principal Investigator: Raul MS Carvalho, MD Centro Hospitalar do Porto
  More Information

No publications provided

Responsible Party: Raul Carvalho, Anesthesiology Consultant, Centro Hospitalar do Porto
ClinicalTrials.gov Identifier: NCT01337115     History of Changes
Other Study ID Numbers: TA 007/11(004-DEFI/007-CES)
Study First Received: April 15, 2011
Results First Received: March 21, 2012
Last Updated: May 17, 2012
Health Authority: Portugal: Ethics Committee for Clinical Research

Keywords provided by Centro Hospitalar do Porto:
Postoperative pain
Knee arthroplasty
Peripheral nerve blocks
Sciatic nerve block
Femoral nerve block

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics, Local
Ropivacaine
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013