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Analgesic Efficacy of Saphenous Nerve Block in Total Knee Replacement

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01991288
First Posted: November 25, 2013
Last Update Posted: November 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
DR. Jassim Rauf, Cork University Hospital
  Purpose
We hypothesize that preoperative saphenous nerve block (SNB) in combination with periarticular local infiltration provides better post operative pain relief (POPR) profile as compared to local infiltration alone

Condition Intervention Phase
Post Operative Pain Procedure: SNB Saphenous Nerve Block Procedure: NSNB Non Saphenous Nerve Block Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Saphenous Nerve Block Improve Analgesia After Total Knee Replacement When Used in Combination With Local Infiltration Analgesia? A Prospective Randomised Double Blinded Trial.

Further study details as provided by DR. Jassim Rauf, Cork University Hospital:

Primary Outcome Measures:
  • Pain on movement at 24 hours time point post operatively [ Time Frame: 24 hours hours time point ]

Secondary Outcome Measures:
  • pain on movement at 6 and 12 hour time point [ Time Frame: 6 and 12 hours time points ]
  • pain at rest at 6, 12 and 24 hours time points [ Time Frame: 6, 12 and 24 hours time points ]
  • Maximum Knee Flexion at 6, 12 and 24 hours time points [ Time Frame: 6, 12 and 24 hours time points ]
  • Maximum Straight Leg Raise Test at 6, 12 and 24 hours time points [ Time Frame: 6, 12 and 24 hours time points ]
  • Time to First request for rescue analgesia [ Time Frame: 24 hours ]
  • Cumulative Opioid consumption in 24 hours [ Time Frame: 24 hours ]
  • Cumulative opioid consumption till discharge [ Time Frame: till discharge time ]
  • 6 Minute walk test [ Time Frame: At 24 hours Post block Conduction ]

Other Outcome Measures:
  • Time to discharge from hospital [ Time Frame: 1 week ]

Enrollment: 20
Study Start Date: November 2012
Study Completion Date: July 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SNB Saphenous Nerve block
Patients received SNB preoperatively at mid thigh level with ultrasound guidance. 10 mls 0.5% bupivacaine was administered for nerve block by the anesthetist. All patients also received peri operative Local Infiltration Analgesia by the surgeon. All patients will receive preoperative oxycontin, peri operative paracetamol and diclofenac. Post operatively all patients received regular paracetamol 1g 6 hourly, Diclofenac sodium 12 hourly and oxycontin 10-20 mg 12 hourly. All patients received standardized spinal block by the same anesthetist, post nerve block for surgery.
Procedure: SNB Saphenous Nerve Block
Patients in group SNB received an ultrasound guided SNB (a sub sartorial approach) by a single operator with 10 mls 0.5% bupivacaine. At the end of surgery periarticular knee infiltration of 30 mls 0.5% levobupivacaine + 70 mls 0.9% saline + 0.5 mg adrenaline was performed in a staged fashion by the surgeon, beginning with infiltration of the deep structures on tibial surface at 1mm depth around all exposed tissues, medial and lateral collateral ligament origin, all cut surfaces of extensor mechanism, all cut surface of skin and subcutaneous tissue
Other Names:
  • Bupivacaine
  • Levobupivacaine
  • Adrenaline
  • 0.9% NaCl
Active Comparator: NSNB Non Saphenous Nerve Block
Patients only received Local Infiltration Analgesia. As per protocol all patients received the same pre, peri and post operative analgesia as described in the experimental group. All patients had a standardized spinal block for surgery.
Procedure: NSNB Non Saphenous Nerve Block
All patients at the end of surgery received periarticular knee infiltration of 30 mls 0.5% levobupivacaine + 70 mls 0.9% saline + 0.5 mg adrenaline, in a staged fashion by the surgeon, beginning with infiltration of the deep structures on tibial surface at 1mm depth around all exposed tissues, medial and lateral collateral ligament origin, all cut surfaces of extensor mechanism, all cut surface of skin and subcutaneous tissue
Other Names:
  • Levobupivacaine
  • Adrenaline
  • 0.9% NaCl

Detailed Description:

Introduction:

Local infiltration analgesia (LIA) is considered acceptable after total knee replacements (TKR) in terms of analgesia, ease of performance, early mobilization and early hospital discharge . Continuous femoral nerve block has been used to enhance post op pain relief (POPR) for TKR but at the expense of motor blockade . A Sub sartorial approach to saphenous nerve block (SNB) spares the motor block . To date the role of saphenous nerve block for POPR in TKR has not been evaluated.

Methodology:

In order to test this hypothesis, we proposed to carry out a prospective randomized controlled double blinded (surgeon and assessor) trial study. With institutional ethics approval and having obtained written informed consent from each patient, 20 ASA 1 - 3 patients scheduled to undergo TKR under spinal anesthesia +/- sedation were allocated to one of two groups i.e. Group (SNB): patients receiving SNB sub sartorial approach and Group (NSNB): patients not receiving SNB.

Group allocation was determined using computer generated random number tables. Sealed envelopes were opened on the day of the surgery by the attending anesthetist responsible for the care of the recruited patient.

Postoperative period:

Patients were then assessed for pain at rest and on movement on arrival in recovery and then at 6 , 12 and 24 hrs. Visual analogue scale on a 10 cm straight line was used to assess postoperative pain scores as predictive value of post operative analgesia on rest and movement i.e passive flexion of knee to 30 degree . Patients were assessed for any motor block by using maximum tolerable range of active knee flexion (MKF) and maximum range of straight leg raise(MSLR) on arrival in recovery and at 6, 12 and 24 hrs. All patients received regular paracetamol 1g 6 hourly, diclofenac 75 mg 12 hourly, oxycontin 10-20 mg ( depending on age) 12 hourly and oxynorm 10 mg as rescue analgesia.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

American Society of Anaesthesia (ASA) Grade I-lll patients Undergoing elective Total Knee Arthroplasty Patients able to consent and understand all the components of the study.

Exclusion Criteria:

Demented patients Patients having bilateral Knee Replacements Patients unable to comprehend the use of pain scales Allergy to any of the medications used in the study Renal dysfunction Coagulation disorders Peptic ulcer disease precluding use of non-steroidal anti-inflammatory drugs (NSAIDs) Patients unable to use regular opioid medication Any chronic pain condition other than osteoarthritis of the knee.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991288


Locations
Ireland
Dept. of Anaesthesia & Intensive Care Unit, Cork University Hospital
Cork, Ireland, 0000
Sponsors and Collaborators
Cork University Hospital
Investigators
Study Director: George Shorten, FFARCSI, PhD Dept. of Anaesthesia & ICU, Cork University Hospital, Cork, Ireland
  More Information

Responsible Party: DR. Jassim Rauf, Specialist Registrar, Cork University Hospital
ClinicalTrials.gov Identifier: NCT01991288     History of Changes
Other Study ID Numbers: JR-0786-GI
First Submitted: November 17, 2013
First Posted: November 25, 2013
Last Update Posted: November 25, 2013
Last Verified: November 2013

Keywords provided by DR. Jassim Rauf, Cork University Hospital:
Total Knee Replacement
Bupivacaine
Levobupivacaine
Saphenous Nerve Block
Local Infiltration Analgesia

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Bupivacaine
Levobupivacaine
Epinephrine
Racepinephrine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics