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NCT Number: NCT01931332

Intrathecal Diamorphine Versus Femoral Nerve Block in Primary Total Knee Arthroplasty

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).

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Key information

Conditions

Osteoarthritis Agnosia Arthritis Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Rheumatic Diseases Signs and Symptoms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Devon and Exeter Hospital

Exeter, Devon, EX1 2ED, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

Femoral Nerve Block with levobupivicaine

Procedure

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

Intrathecal injection of diamorphine

Procedure

500mcg of intrathecal diamorphine (ID) (dissolved in 0.5mls normal saline)

Primary outcomes

  1. Median pain score (NRS: see below) at rest

    Time frame: Over 72 hours post operatively

    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.

Secondary outcomes

  1. Pain on movement

    Time frame: At 3 hrs postoperatively

    Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain)

  2. Pain on movement

    Time frame: At 6 hrs postoperatively

    Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain)

  3. Pain on movement

    Time frame: At 12 hrs postoperatively

    Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain)

  4. Pain on movement

    Time frame: At 24 hrs postoperatively

    Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain)

  5. Pain on movement

    Time frame: At 48 hrs postoperatively

    Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain)

  6. Pain on movement

    Time frame: At 72 hrs postoperatively

    Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain)

  7. Pain at rest

    Time frame: At 3 hrs postoperatively

    Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain)

  8. Pain at rest

    Time frame: At 6 hrs postoperatively

    Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain)

  9. Pain at rest

    Time frame: At 12 hrs postoperatively

    Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain)

  10. Pain at rest

    Time frame: At 24 hrs postoperatively

    Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain)

  11. Pain at rest

    Time frame: At 48 hrs postoperatively

    Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain)

  12. Pain at rest

    Time frame: At 72 hrs postoperatively

    Numerical rating scale (NRS) score (where 0 = no pain and 10 = worst possible pain)

  13. Morphine consumption

    Time frame: Over 72 hrs postoperatively

    Cumulative consumption in milligrams

Other outcomes

  1. Quality of recovery score 40

    Time frame: Day 2 post operatively

    Quality of recovery score is a 40 point patient reported outcome measure devised by Paul Myles and reported in the British Journal of Anaesthesia 84 (1): 11-15 (2000). This psychometric tool assess emotional state, physical comfort, psychological support, physical independence and pain grading each out of 5 (0= lowest score and 5 = highest score). We ranked total score as extremely poor (0-40), poor (41-80), satisfactory (81-120), good (121-160) or excellent (161-200).

  2. Total Pain Relief Score (TOTPAR)

    Time frame: Day 1,2 and 3 post-operatively

    Percentage of the maximum total pain relief was calculated by dividing the total pain relief (TOTPAR) over the three days by the maximum potential pain relief and expressed as a percentage (%maxTOTPAR)

  3. Functional health outcome measure

    Time frame: At 6 weeks post-operatively

    The Oxford Knee Score (OKS) is a 12-item patient-reported questionnaire specifically designed and developed to assess function and pain after total knee arthroplasty. It is short, reproducible, valid and sensitive to clinically important changes.

    The OKS was designed to be completed by the patient thus minimising potential bias unwittingly introduced by surgeons when assessing the results themselves.

    The PRO was designed and developed by researchers within Public Health and Primary Health Care at the University of Oxford in association with surgical colleagues at the Nuffield Orthopaedic Centre.

    The OKS at 6 weeks was compared to the preoperative OKS to describe the change in functional outcome.

  4. Physical health outcome

    Time frame: A 6 weeks post-operatively

    EuroQol 5 Dimensions Score/Visual Analogue Score (EQ-5D™/VAS). This is a standardised instrument for use as a measure of health outcome. It uses a patient self reporting 5 point (3 level) questionnaire and visual analogue scale to measure health. Health improvement at 6 weeks was assessed by comparing with pre-operative scores.

Sponsors and collaborators

Lead sponsor

Royal Devon and Exeter NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 29, 2013
Registry last updated
Aug 29, 2013

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.

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