Condition category
Musculoskeletal Diseases
Date applied
11/07/2017
Date assigned
25/07/2017
Last edited
25/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Trial website

N/A

Contact information

Type

Public

Primary contact

Miss Nina Mathijssen

ORCID ID

Contact details

Reinier de Graaf Hospital
Reinier de Graafweg 5
Delft
2625AD
Netherlands

Additional identifiers

EudraCT number

2012-000989-37

ClinicalTrials.gov number

Protocol/serial number

2012-002-M

Study information

Scientific title

Local infiltration anaesthesia in total hip arthroplasty by anterior supine intermuscular approach

Acronym

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

METC ZuidWest Holland, 01/06/2012, ref: NL39970.098.12

Study design

Interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

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

Phase

Drug names

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

01/06/2011

Overall trial end date

01/01/2018

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

75

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

United Kingdom

Trial participating centre

Reinier de Graaf Hospital
Reinier de Graafweg 5
Delft
2625AD
Netherlands

Sponsor information

Organisation

Reinier de Graaf Groep, department of orthopaedics

Sponsor details

Reinier de Graafweg 5
Delft
2625AD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

N/A

Funders

Funder type

Government

Funder name

Reinier de Graaf Groep

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

01/01/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28836971

Publication citations

Additional files

Editorial Notes

25/08/2017: Publication reference added.