Intrathecal Diamorphine Versus Femoral Nerve Block in Primary Total Knee Arthroplasty

Study Overview
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Brief Summary
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Primary total knee arthroplasty (TKA) is commonly associated with moderate to severe early post-operative pain. The primary aim of this study was to investigate the impact of either a single-shot femoral nerve block (FNB) or intrathecal diamorphine (ID) on post-operative pain after TKA The Null Hypothesis is that there is no difference in the post operative pain relief provided for TKA by a single-shot femoral nerve block (FNB) as compared to intrathecal diamorphine (ID).

Detailed Description
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In 2008, the Prospect Working Group, a multidisciplinary expert panel, published their consensus guidelines on the relative merits of different anaesthetic and analgesic techniques for TKA based on a review of the available published literature up to 2005. These guidelines supported the use of general anaesthesia combined with a femoral nerve block for surgery and postoperative analgesia, or alternatively spinal anaesthesia with local anaesthetic combined with spinal morphine. The preference for femoral nerve block in favour of intrathecal opiates was as a consequence of the greater potential for side effects with the latter technique. The authors conceded that there were a lack of well-conducted studies on this subject, graded their recommendations as level D (expert opinion), and concluded further research was needed. Consequently there has been debate around the conclusions drawn and clinicians have not universally accepted the recommendations. Most researchers to date have focused on short-term outcomes such as static pain scores and/or opiate consumption. It is also important however to investigate dynamic pain scores, patient reported outcomes, the attainment of rehabilitation goals, length of stay and longer term functional outcomes. In addition, the use of the total pain relief score (TOTPAR) as described by Cooper and Beaver, assesses the cumulative response to treatment. This is a well validated area under the time-analgesic effect curve (AUC) derivation for pain relief which is commonly used by meta-analyses of analgesic interventions. The aim of this study is to investigate all these endpoints in patients receiving a single-shot femoral nerve block (FNB) for TKA as compared to intrathecal diamorphine (ID), a more commonly used spinal opiate in United Kingdom anaesthetic practice.

Official Title
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Randomised, Observer Blinded, Controlled Trial of Intrathecal Diamorphine Versus Femoral Nerve Block for Post-operative Analgesia Following Primary Total Knee Arthroplasty

Conditions
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Osteoarthritis

Intervention / Treatment
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* Procedure: Femoral Nerve Block with levobupivicaine
* Procedure: Intrathecal injection of diamorphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients scheduled for primary unilateral Total Knee Arthroplasty Exclusion Criteria: Uni-compartmental surgery, bilateral surgery, contra-indication to spinal anaesthesia or peripheral nerve block (anticoagulation, hydrocephalus, raised intracranial pressure), allergy to local anaesthetics or diamorphine, malignant hyperthermia or other concerns over general anaesthesia, chronic opiate use and chronic pain medication use (e.g. gabapentin, pregabalin, amitriptyline).

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Femoral Nerve Block with levobupivicaine<br>A single injection femoral nerve block (FNB) was performed in the supine position with a 50mm insulated needle (NanoLine, Pajunk, Geisingen, Germany) and peripheral nerve stimulator set at 1Hertz (Hz) with pulse width 0.1ms. Once a quadriceps muscle twitch was identified at a stimulated current between 0.2 and 0.5milliamperes (mA), 20mls of 0.375% levobupivacaine (75mg) was injected in fractionated amounts after negative aspiration | Procedure: Femoral Nerve Block with levobupivicaine<br>* A single injection femoral nerve block (FNB) performed in the supine position with a 50mm insulated needle (NanoLine, Pajunk, Geisingen, Germany) and peripheral nerve stimulator set at 1Hz with pulse width 0.1ms. Once a quadriceps muscle twitch is identified at a stimulated current between 0.2 and 0.5mA, 20mls of 0.375% levobupivacaine (75mg) is injected in fractionated amounts after negative aspiration<br>|
| Active Comparator: Intrathecal injection of diamorphine<br>500mcg of intrathecal diamorphine (ID) (dissolved in 0.5mls normal saline) | Procedure: Intrathecal injection of diamorphine<br>* 500mcg of intrathecal diamorphine (ID) (dissolved in 0.5mls normal saline)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median pain score (NRS: see below) at rest | Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain) assessed at times 3, 6, 12, 24, 48 and 72 hrs postoperatively. | Over 72 hours post operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on movement | Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain) | At 3 hrs postoperatively | 
| Pain on movement | Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain) | At 6 hrs postoperatively | 
| Pain on movement | Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain) | At 12 hrs postoperatively | 
| Pain on movement | Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain) | At 24 hrs postoperatively | 
| Pain on movement | Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain) | At 48 hrs postoperatively | 
| Pain on movement | Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain) | At 72 hrs postoperatively | 
| Pain at rest | Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain) | At 3 hrs postoperatively | 
| Pain at rest | Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain) | At 6 hrs postoperatively | 
| Pain at rest | Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain) | At 12 hrs postoperatively | 
| Pain at rest | Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain) | At 24 hrs postoperatively | 
| Pain at rest | Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain) | At 48 hrs postoperatively | 
| Pain at rest | Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain) | At 72 hrs postoperatively | 
| Morphine consumption | Cumulative consumption in milligrams | Over 72 hrs postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroplasty, Analgesia