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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
SNB plus CFNB
CFNB
Sponsored by
Centro Hospitalar do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative pain, Knee arthroplasty, Peripheral nerve blocks, Sciatic nerve block, Femoral nerve block

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centro Hospitalar do Porto, Serviço de Anestesia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Continuous femoral nerve block (CFNB)

Single shot SNB plus CFNB

Arm Description

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

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

Outcomes

Primary Outcome Measures

Visual Analogue Scores (VAS) - Pain Scores Measured in mm (0-100)
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)
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)
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
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

Full Information

First Posted
April 15, 2011
Last Updated
May 17, 2012
Sponsor
Centro Hospitalar do Porto
Collaborators
Universidade do Porto
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1. Study Identification

Unique Protocol Identification Number
NCT01337115
Brief Title
Effect of a Sciatic Block (SNB) Combined With a Continuous Femoral Block (CFNB) on Pain Scores After Knee Arthroplasty
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Hospitalar do Porto
Collaborators
Universidade do Porto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Postoperative pain, Knee arthroplasty, Peripheral nerve blocks, Sciatic nerve block, Femoral nerve block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous femoral nerve block (CFNB)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Single shot SNB plus CFNB
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
SNB plus CFNB
Other Intervention Name(s)
Peripheral nerve blocks, Local anesthetics, Ropivacaine, Femoral nerve block, Sciatic nerve block
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
CFNB
Other Intervention Name(s)
Peripheral nerve blocks, Local anesthetics, Ropivacaine, Femoral nerve block
Intervention Description
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
Primary Outcome Measure Information:
Title
Visual Analogue Scores (VAS) - Pain Scores Measured in mm (0-100)
Description
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
Time Frame
15-30 min after arrival on post anesthesia care unit (PACU)
Title
VAS Results - Pain Measured in mm (0-100)
Description
VAS pain scores are measured by blinded investigators 12h after surgery . VAS scale: 0 - no pain 100 - worst possible pain
Time Frame
12h after surgery
Title
VAS Results - Pain Scores Measured in mm (0-100)
Description
VAS pain scores are measured by blinded investigators 24h after surgery . VAS scale: 0 - no pain 100 - worst possible pain
Time Frame
24h after surgery
Secondary Outcome Measure Information:
Title
Satisfaction With Anesthesia Technique in Each Arm of the Study
Description
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
Time Frame
1 month after surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raul MS Carvalho, MD
Organizational Affiliation
Centro Hospitalar do Porto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Hospitalar do Porto, Serviço de Anestesia
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal

12. IPD Sharing Statement

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

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