Trial to Compare Femoral Nerve Block With Local Anaesthetic Injection for Post-operative Pain After Knee Replacement.

NCT02288923 | Completed

• 2 other identifiers: 14/SW/0016139814
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

Pain after a knee replacement can impair recovery and use of the new knee. Having an injection to numb the femoral nerve is known to give good pain relief after the operation but may lead to slower mobilisation as it also prevents the patient from moving the knee. Recent studies have shown that infiltration of local anaesthetic (LIA) within the new knee joint may also give good pain relief. The null hypothesis is that there is no difference in primary or secondary outcome measures between femoral nerve block and LIA, as anaesthetic techniques for knee replacement.

Conditions

Arthritis Knee

Keywords

Total knee arthroplasty; Femoral nerve block; Local infiltration analgesia

Outcome Measures

Primary Outcomes (1)

• Morphine consumption in first post-operative 72 hours

  The total amount of morphine consumed by the patient in the first 72 post-operative hours will be added up. If morphine has been given orally it will be counted as ⅓ the intravenous dose.

  72 hours

Secondary Outcomes (7)

• Total pain relief score

  Post op days 1, 2 and 3

• Post operative pain scores

  Day 0 - 3 post op

• Achievement of rehabilitation goals

  1-4 days post operatively

• Readiness for discharge

  Post operative day 2-10

• Patient satisfaction

  2nd post-operative day

Study Arms (2)

Femoral nerve block

ACTIVE COMPARATOR

Femoral nerve block with 20ml 0.375% Levobupivacaine

Procedure: Femoral nerve block; Procedure: Sub arachnoid analgesia; Procedure: Sedation or general anaesthesia; Drug: Pre-medication; Drug: Intra-operative medication; Drug: Post-operative analgesia - morphine; Drug: Post-operative analgesia - ibuprofen and paracetamol; Drug: Regular anti emetics

Local Infiltration Analgesia

ACTIVE COMPARATOR

Local infiltration of knee joint using 40ml of bupivacaine 0.25% with adrenaline 1:200 000, diluted to 150ml with saline 0.9%. This is then divided into thirds; 50ml into the posterior capsule before cementing, 50ml into the medial and lateral capsules and 50ml into subcutaneous tissues and in and around the vastus medialis and sartorius muscles (where it may block the saphenous nerve).

Procedure: Local Infiltration Analgesia; Procedure: Sub arachnoid analgesia; Procedure: Sedation or general anaesthesia; Drug: Pre-medication; Drug: Intra-operative medication; Drug: Post-operative analgesia - morphine; Drug: Post-operative analgesia - ibuprofen and paracetamol; Drug: Regular anti emetics

Interventions

Femoral nerve block PROCEDURE

Supine position If using peripheral nerve stimulator for localisation of the femoral nerve: 50 mm insulated needle Peripheral nerve stimulator set at 2 Hz with pulse width 100μs When quadriceps muscle twitch is present with a stimulated current between 0.2 and 0.5mA, inject 20ml 0.375% (3.75mg/ml) Levo- bupivacaine If using ultrasound for localisation of the femoral nerve: High frequency linear array probe Short bevelled nerve-block needle, using in or out of plane technique Inject 20ml 0.375% (3.75mg/ml) Levo-bupivacaine underneath fascia iliaca ensuring adequate spread of local anaesthetic

Also known as: Femoral nerve blockade, Regional anaesthesia femoral nerve

Femoral nerve block

Local Infiltration Analgesia PROCEDURE

Local infiltration analgesia to be administered by surgeon towards the end of operation: 40ml of bupivacaine 0.25% with adrenaline 1:200 000, diluted to 150ml with saline 0.9%. This is then divided into thirds; 50ml into the posterior capsule before cementing, 50ml into the medial and lateral capsules and 50ml into subcutaneous tissues and in and around the vastus medialis and sartorius muscles (where it may block the saphenous nerve).

Also known as: LIA

Local Infiltration Analgesia

Sub arachnoid analgesia PROCEDURE

Patients in both arms of the trial will be given sub arachnoid anasthesia of 2.5-3.0ml of plain bupivacaine 0.5% using a 25G Whitacre needle. Patients may have 0-4mg midazolam and/or 0-1mcg/kg fentanyl and/or 0-4mcg/ml propofol sedation using the Marsh protocol if required for this procedure as deemed appropriate by the anaesthetist.

Femoral nerve block; Local Infiltration Analgesia

Sedation or general anaesthesia PROCEDURE

After insertion of the sub arachnoid anaesthesia the patient may choose to be fully asleep or sedated. If they choose to be fully asleep, they may have up to 2mcg/kg fentanyl in total (including any given at time of subarachnoid injection), muscle relaxation as indicated for facilitation of intubation where needed, airway control using LMA or tracheal tube where needed, and general anaesthesia maintained using inspired oxygen concentration of 0.3-0.7 with propofol up to 5mcg/kg (Marsh protocol) or isoflurane or sevoflurane. If the patient chooses to have sedation they may have additional midazolam up to a total dose of 4mg and/or a propofol infusion (Marsh protocol) of 0-4mcg/ml.

Femoral nerve block; Local Infiltration Analgesia

Pre-medication DRUG

All patients will receive 1g paracetamol pre-operatively. Those on non steroidal anti inflammatory drugs may continue to take them. Apart from these, no other pain relieving pre-medications are to be used. Patients may be given anxiolysis using temazepam 10-20mg or diazepam 2-5mg by mouth if required. Antacid premedication is permitted using ranitidine, metoclopramide or proton pump inhibitors.

Femoral nerve block; Local Infiltration Analgesia

Intra-operative medication DRUG

If paracetamol has not been given pre-operatively, it will be given intraoperatively 1g IV. Where 2 or more of the following risk factors are present; female, non smoker, previous post operative nausea or vomiting, intra operative opiates, the patients will be given 4mg dexamethasone and or 4mg ondansetron IV. Vasopressor drugs may be given at the anaesthetist's discretion to maintain an appropriate blood pressure. Intraoperative fluid infusion is at the discretion of the anaesthetist. Antibiotic prophylaxis is as per the hospital protocol (currently 6mg/kg Teicoplanin IV and 3mg/kg gentamicin pre induction). Tranexamic acid will be given as per unit protocol, (currently 1g pre-operatively IV and 500mg orally at 8 hours post op. unless contraindicated by a high risk of thrombosis.)

Femoral nerve block; Local Infiltration Analgesia

Post-operative analgesia - morphine DRUG

Patients will all be given a morphine pump which will give 1mg every 5 minutes. This is to be discontinued after 48 hours and changed to oral morphine 10-20mg if weight 50-70kg, 20-30mg if weight \>70kg 2 hourly.

Femoral nerve block; Local Infiltration Analgesia

Post-operative analgesia - ibuprofen and paracetamol DRUG

All patients will be given 1g paracetamol 6 hourly and 400mg ibuprofen 8 hourly unless there are contraindications. If patients are on an alternative non-steroidal anti inflammatory drug then this may be substituted for ibuprofen.

Femoral nerve block; Local Infiltration Analgesia

Regular anti emetics DRUG

All patients will receive 4mg ondansetron regularly for 2 days. They will be prescribed 50mg cyclizine as an addition to this if needed.

Femoral nerve block; Local Infiltration Analgesia

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients presenting for primary knee arthroplasty under the care of the Exeter Knee Unit Consultants Messrs Toms, Eyres, Cox, Mandalia, Schrantz.

You may not qualify if:

• Total knee arthroplasty for trauma
• Unicompartmental surgery
• Bilateral surgery
• Contra indication to spinal anaesthesia or peripheral nerve blocks (anticoagulation, hydrocephalus, raised intracranial pressure, peripheral neuropathy)
• Allergy to local anaesthetics or morphine
• Chronic pain:
• Under active follow up by chronic pain team
• Chronic strong opiate use (morphine, oxycodone, buprenorphine, pethidine, methadone). Codeine, dihydrocodeine and tramadol are not included
• Other chronic pain medications (including gabapentin, pregabalin or amitriptyline)
• Unable to adequately understand verbal explanations or written information given in English, or patients with special communication needs -

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead

Study Sites (1)

Royal Devon and Exeter NHS Foundation Trust

Exeter, Devon, EX2 5DW, United Kingdom

Location

MeSH Terms

Interventions

Anesthesia, General; Acetaminophen

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Fiona Martin, MBCHB

  Royal Devon and Exeter NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: November 13, 2014
• Study Start: March 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: March 28, 2019

Record last verified: 2019-03

Locations

GB (1)