The effect of extra local anaesthesia during total hip arthroplasty
| ISRCTN | ISRCTN15422220 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15422220 |
| EudraCT/CTIS number | 2012-000989-37 |
| Secondary identifying numbers | 2012-002-M |
- Submission date
- 11/07/2017
- Registration date
- 25/07/2017
- Last edited
- 17/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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
N.Mathijssen@rdgg.nl
Contact information
Public
Reinier de Graaf Hospital
Reinier de Graafweg 5
Delft
2625AD
Netherlands
Study information
| Study design | Interventional randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Local infiltration anaesthesia in total hip arthroplasty by anterior supine intermuscular approach |
| Study hypothesis | 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. |
| Ethics approval(s) | METC ZuidWest Holland, 01/06/2012, ref: NL39970.098.12 |
| Condition | Osteoarthritis of the hip |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/06/2011 |
| Overall study end date | 01/01/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 75 |
| 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 |
| 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 | 06/11/2012 |
| Recruitment end date | 09/01/2014 |
Locations
Countries of recruitment
- Netherlands
- United Kingdom
Study participating centre
Delft
2625AD
Netherlands
Sponsor information
Hospital/treatment centre
Reinier de Graafweg 5
Delft
2625AD
Netherlands
"ROR" |
https://ror.org/00wkhef66 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/01/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Nina Mathijssen (N.Mathijssen@rdgg.nl). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 24/08/2017 | Yes | No |
Editorial Notes
17/01/2020: Internal review.
25/08/2017: Publication reference added.
