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Analgesic Efficacy of Saphenous Nerve Block in Total Knee Replacement

Primary Purpose

Post Operative Pain

Status
Completed
Phase
Phase 4
Locations
Ireland
Study Type
Interventional
Intervention
SNB Saphenous Nerve Block
NSNB Non Saphenous Nerve Block
Sponsored by
Cork University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring Total Knee Replacement, Bupivacaine, Levobupivacaine, Saphenous Nerve Block, Local Infiltration Analgesia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dept. of Anaesthesia & Intensive Care Unit, Cork University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SNB Saphenous Nerve block

NSNB Non Saphenous Nerve Block

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain on movement at 24 hours time point post operatively

Secondary Outcome Measures

pain on movement at 6 and 12 hour time point
pain at rest at 6, 12 and 24 hours time points
Maximum Knee Flexion at 6, 12 and 24 hours time points
Maximum Straight Leg Raise Test at 6, 12 and 24 hours time points
Time to First request for rescue analgesia
Cumulative Opioid consumption in 24 hours
Cumulative opioid consumption till discharge
6 Minute walk test

Full Information

First Posted
November 17, 2013
Last Updated
November 21, 2013
Sponsor
Cork University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01991288
Brief Title
Analgesic Efficacy of Saphenous Nerve Block in Total Knee Replacement
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cork University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
Total Knee Replacement, Bupivacaine, Levobupivacaine, Saphenous Nerve Block, Local Infiltration Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SNB Saphenous Nerve block
Arm Type
Experimental
Arm Description
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.
Arm Title
NSNB Non Saphenous Nerve Block
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
SNB Saphenous Nerve Block
Other Intervention Name(s)
Bupivacaine, Levobupivacaine, Adrenaline, 0.9% NaCl
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
NSNB Non Saphenous Nerve Block
Other Intervention Name(s)
Levobupivacaine, Adrenaline, 0.9% NaCl
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain on movement at 24 hours time point post operatively
Time Frame
24 hours hours time point
Secondary Outcome Measure Information:
Title
pain on movement at 6 and 12 hour time point
Time Frame
6 and 12 hours time points
Title
pain at rest at 6, 12 and 24 hours time points
Time Frame
6, 12 and 24 hours time points
Title
Maximum Knee Flexion at 6, 12 and 24 hours time points
Time Frame
6, 12 and 24 hours time points
Title
Maximum Straight Leg Raise Test at 6, 12 and 24 hours time points
Time Frame
6, 12 and 24 hours time points
Title
Time to First request for rescue analgesia
Time Frame
24 hours
Title
Cumulative Opioid consumption in 24 hours
Time Frame
24 hours
Title
Cumulative opioid consumption till discharge
Time Frame
till discharge time
Title
6 Minute walk test
Time Frame
At 24 hours Post block Conduction
Other Pre-specified Outcome Measures:
Title
Time to discharge from hospital
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Shorten, FFARCSI, PhD
Organizational Affiliation
Dept. of Anaesthesia & ICU, Cork University Hospital, Cork, Ireland
Official's Role
Study Director
Facility Information:
Facility Name
Dept. of Anaesthesia & Intensive Care Unit, Cork University Hospital
City
Cork
ZIP/Postal Code
0000
Country
Ireland

12. IPD Sharing Statement

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Analgesic Efficacy of Saphenous Nerve Block in Total Knee Replacement

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