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

NCT01337115 | Completed Results

• 1 other identifier: TA 007/11(004-DEFI/007-CES)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Postoperative pain; Knee arthroplasty; Peripheral nerve blocks; Sciatic nerve block; Femoral nerve block

Outcome Measures

Primary Outcomes (3)

• 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

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

• 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

  12h after surgery

• 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

  24h after surgery

Secondary Outcomes (1)

• Satisfaction With Anesthesia Technique in Each Arm of the Study

  1 month after surgery

Study Arms (2)

Continuous femoral nerve block (CFNB)

ACTIVE COMPARATOR

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

Single shot SNB plus CFNB

EXPERIMENTAL

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

Interventions

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

Also known as: Peripheral nerve blocks, Local anesthetics, Ropivacaine, Femoral nerve block, Sciatic nerve block

Single shot SNB plus CFNB

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

Also known as: Peripheral nerve blocks, Local anesthetics, Ropivacaine, Femoral nerve block

Continuous femoral nerve block (CFNB)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral total knee replacement

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Hospitalar do Porto: lead
• Universidade do Porto: collaborator

Study Sites (1)

Centro Hospitalar do Porto, Serviço de Anestesia

Porto, Porto District, 4099-001, Portugal

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthetics, Local; Ropivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

Difficulties in contacting patients by phone and getting reliable answers limit the value of the patient satisfaction parameter. No analysis was made on the effect of nerve blocks on rehabilitation

Results Point of Contact

• Title: Dr Raul Carvalho
• Organization: Centro Hospitalar do Porto

raul@meo.pt

+351226176114

Study Officials

• Raul MS Carvalho, MD

  Centro Hospitalar do Porto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Consultant

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 18, 2011
• Study Start: April 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: June 19, 2012
• Results First Posted: June 19, 2012

Record last verified: 2012-05

Locations

PT (1)