Plain English Summary
Background and study aims
Arthritis is a condition that causes joints to become painful and stiff. Hip osteoarthritis can be treated with a total hip arthroplasty (hip replacement surgery), where the damaged hip joint is replaced with an artificial implant. During and after the surgery, patients receive pain medication to be pain free after surgery and to be able to rehabilitate after surgery. Local anaesthesia during surgery might further alleviate pain after surgery. Patients might be able to rehabilitate more easy and faster. Patients might need less medication and might be discharged earlier from the hospital. There are a variety of different types of anaesthia that can be used such as topivacaine and ropivacaine. The aim of this study is to examine the effect of extra local anaesthesia during total hip arthroplasty.
Who can participate?
Adults aged 18 and older who require a total hip replacement
What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group receive an antegrade infiltration that contains topivacaine/ephinephrine. Those in the second group receive a reversed infiltration with ropivacaine/epinephrine. Those in the last group receive a placebo (a dummy) medication containg saline (salt water). Participants are asked to rate their pain, nausea and vomiting after surgery.
What are the possible benefits and risks of participating?
Participants may benefit from a reduction in pain. Participants in the placebo group may experience more pain than the other groups. All participants receive rescue medication when the standard pain medication is insufficient.
Where is the study run from?
Reinier de Graaf Hospital (Netherlands)
When is the study starting and how long is it expected to run for?
June 2011 to January 2018
Who is funding the study?
Reinier de Graaf Hospital (Netherlands)
Who is the main contact?
Miss Nina Mathijssen
Local infiltration anaesthesia in total hip arthroplasty by anterior supine intermuscular approach
1. Patients administered perioperative reversed local infiltration of ropivacaine will have lower pain scores, a faster rehabilitation, and lower cumulative consumption of (opioid-) pain medication postoperative, when compared to patients administered antegrade local infiltration of ropivacaine or saline.
2. Patients administered perioperative antegrade local infiltration of ropivacaine will have lower pain scores, a faster rehabilitation, and lower cumulative consumption of (opioid-) pain medication postoperative, when compared to patients administered antegrade local infiltration of saline.
METC ZuidWest Holland, 01/06/2012, ref: NL39970.098.12
Interventional randomised controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Osteoarthritis of the hip
This study is a randomised, controlled blind (for the patient) trial, comparing the outcomes in patients with coxarthrosis after THA with the ASI technique. Participants are randomised in an antegrade infiltration group with ropivacaine, a reversed infiltration group with ropivacaine and an antegrade placebo infiltration group.
Participants are randomised to the following groups using opaque sealed envelopes on the operating room:
Group 1 Antegrade: Participants receive an antegrade infiltration that contains topivacaine/epinephrine as a dose of 1:100.000 120 ml
Group 2 Reversed: Participants receive a reversed infiltration with ropivacaine/epinephrine as a dose of 1:100.000 120 ml
Group 3 Antegrade placebo: Participants receive an antegrade placebo that contains saline with a dose of 120 ml
Participants are asked if they experienced pain (and how much), nausea and/or vomiting after surgery. The study ends for each participant when they are discharged from the hospital.
Primary outcome measures
Pain is measured using the numerical rating scale (NRS) for pain at one, four and eight hours after surgery, in rest, while and direct after mobilization, starting at four-six hours after surgery.
Secondary outcome measures
1. Pain is measured using the numerical rating scale (NRS) for pain at day two and until the day of discharge at two moments (morning and afternoon). Also during and direct after mobilisation, pain is measured with NRS for pain.
2. Preoperative pain is measured during postoperative screening with NRS for pain, the neuropathic pain diagnostic questionnaire (DN4), and Amsterdam Preoperative Anxiety and Information Scale (APAIS) for anxiety and information requirements
3. Postoperative vomiting and nausea is asked at the moments the NRS is scored
4. Cumulative consumption of opioid medication and pain medication is scored
5. Length of hospital stay by amount of nights is counted at hospital discharge
Overall trial start date
Overall trial end date
Participant inclusion criteria
1. Patients who are diagnosed for a total hip arthroplasty with osteoarthritis
2. Patients aged 18 years and older
3. Patients willing to participate
4. ASA I and II
Target number of participants
Participant exclusion criteria
1. Patients unwilling to participate
2. Mentally retarded
3. Neurological conditions potentially influence pain perception
4. Psychiatric conditions potentially influence pain perception
5. ASA III, IV
6. Cardiovascular impairment in the present or in the past
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Reinier de Graaf Hospital
Reinier de Graafweg 5
Reinier de Graaf Groep, department of orthopaedics
Reinier de Graafweg 5
Reinier de Graaf Groep
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Nina Mathijssen (N.Mathijssen@rdgg.nl).
Intention to publish date
Participant level data
Available on request
Results - basic reporting
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28836971