Skip to main content
OpenTrials
Completed

NCT Number: NCT01337115

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Hospitalar do Porto, Serviço de Anestesia

Porto, Porto District, 4099-001, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SNB plus CFNB

Procedure

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

CFNB

Procedure

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

Primary outcomes

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

    Time frame: 15-30 min after arrival on post anesthesia care unit (PACU)

    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

  2. VAS Results - Pain Measured in mm (0-100)

    Time frame: 12h after surgery

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

    VAS scale:

    0 - no pain 100 - worst possible pain

  3. VAS Results - Pain Scores Measured in mm (0-100)

    Time frame: 24h after surgery

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

    VAS scale:

    0 - no pain 100 - worst possible pain

Secondary outcomes

  1. Satisfaction With Anesthesia Technique in Each Arm of the Study

    Time frame: 1 month after surgery

    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

Sponsors and collaborators

Lead sponsor

Centro Hospitalar do Porto

Other

Collaborators

  • Universidade do Porto

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 18, 2011
Registry last updated
Jun 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.