Combined Local Infiltration Analgesia and Femoral Nerve Blocks in Total Knee Replacements. A Prospective Randomised Controlled Trial
In patients undergoing elective primary unilateral total knee replacements (TKR), does the use of femoral nerve blocks compared to local infiltration analgesia (LIA) or compared to combined femoral nerve blocks and LIA; produce different outcomes in time to post anaesthesia care unit (PACU) and hospital discharge, time to mobilisation, and post-operative opiate consumption and pain scores.
Nambour General Hospital
90 participants
Jun 1, 2014
Interventional
Conditions
Summary
Total knee replacements (TKRs) are one of the most painful orthopaedic procedures and are associated with a protracted recovery period. Multiple techniques are utilised for pain relief and these include femoral nerve blocks (FNBs) and high volume local infiltration analgesia (LIA), the superiority of either is largely contentious. This study aims to assess the differences in several outcomes for patients undergoing total knee replacement using single shot FNBs and LIA. This is a prospective, blinded, single centre randomised controlled trial at Nambour General Hospital, in Queensland, Australia. Ninety (90) patients having TKRs will be sought during their visit to the Pre-Anaesthetic Evaluation Unit (PAEU) and assessed against the eligibility criteria. Inclusion criteria are patients who consent to participate in the study; ability to comprehend pain scoring and ability to use PCA machine; elective primary unilateral TKR performed at NGH; American Society of Anesthesiologists (ASA) Physical Status I-III; and patients aged 18-85 years. The exclusion Criteria are patients who lack capacity, or are unwilling, to consent to the study; patients with pre-existing chronic pain syndromes; patients with opioid tolerance (opioid consumption >30mg oral morphine or equivalent per day; chronic gabapentin or pregabalin analgesic therapy; patients with known contraindication, allergy, intolerance or previous reaction to any of the drugs being administered; inability to walk independently prior to TKR; Body Mass Index >40 kg/m2; patients <18 years of age; patients who are pregnant; and patients who have dementia. Participants will be randomly selected using a blocked permuted randomisation method for Arm 1 – Single Shot FNB and placebo LIA, Arm 2 – LIA and placebo FNB, or Arm 3 – Single Shot FNB and LIA. The trial will be double-blinded. The trial looks to determine how explanatory variables (FNB, LIA) relate to total opiate consumption and highest pain scores in the immediate post-operative recovery period and at 4/12/24/48 hours (4/24/48 hours for pain scores) post-operatively and at hospital discharge, time to Post-Anaesthesia Care Unit (PACU) and hospital discharge, and time to mobilisation (outcome variables).
Eligibility
Inclusion Criteria5
- i. Elective primary unilateral TKR performed at NGH
- ii. Patients who consent to participate in the study
- iii. Ability to comprehend pain scoring and ability to use PCA machine
- iv. American Society of Anesthesiologists (ASA) Physical Status I-III
- v. Patients aged 18-85 years
Exclusion Criteria10
- i. Patients who lack capacity, or are unwilling, to consent to the study
- ii. Patients with pre-existing chronic pain syndromes
- iii. Patients with opioid tolerance (opioid consumption >30mg oral morphine or equivalent per day)
- iv. Chronic gabapentin or pregabalin analgesic therapy
- v. Patients with known contraindication, allergy, intolerance or previous reaction to any of the drugs being administered
- vi. Inability to walk independently prior to TKR
- vii. Body Mass Index (BMI) >40 kg/m2
- viii. Patients <18 years of age
- ix. Patients who are pregnant
- x. Patients who have dementia
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Arm 2 - Local infiltration analgesia and placebo femoral nerve block. Arm 3 - Combined femoral nerve block and local infiltration analgesia. Local Infiltration Analgesia: The drugs infiltrated into the joint will comprise: 150ml 0.2% ropivacaine (Arm 2), 130ml 0.2% ropivacaine plus 20ml normal saline (Arm 3). 1ml 1:1000 adrenaline (Arm 2 and 3). 30mg ketorolac (Arm 2 and 3). Prior to implantation of the components, the posterior capsule will be infiltrated with the mixture. The synovium over the posterior cruciate ligament (PCL) in the notch as well as the medial and lateral collateral areas will be infiltrated. Following implantation of the new joint further injection into the capsule and over the anterior aspect will be conducted. The fat pad, which is richly innervated, will also be injected. Further infiltration will be carried out subcutaneously prior to skin closure, followed by injection into the joint as a bolus of any residual mixture. Femoral Nerve Block: Performed post induction of anaesthesia with the aid of ultrasound identification of the femoral nerve. Injection of 20ml normal saline (Arm 2), or 20ml 0.2% ropivacaine (Arm 3) around the nerve, with a pool of drug/placebo administered immediately adjacent to either the posterolateral or anterior aspects.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12614000502639