None listed
Conditions
Brief summary
This study aims to to determine whether using Local infiltration anaesthetic (LIA) vs LIA + continuous post-operative infusion of local anaesthetic for 48 hours using an elastomeric pump effects pain, opioid usage and, length of stay after a total hip replacement via the anterior approach. Each participant will be randomly selected into one of 2 groups. Group A will receive local infiltration anaesthetic to the surgical site during the operation, whilst Group B will receive local infiltration anaesthetic during the operation as well as an On-Q pump wound catheter that will provide continuous local anaesthetic to the surgical site for 48 hours after the surgery. After 48 hours, the On-Q pump will then be removed by the nursing staff on the ward by simple extraction. The Primary Outcome for this study will be opioid consumption between the 2 cohort groups. This outcome will be measured by calculating the total opioid usage for each participant and converting this to an oral morphine equivalent dose. The Secondary outcomes for this study are length of hospital stay measured from the admission day to the day of discharge from the ward, pain scores measured on the Verbal Analogue Scale (VAS), anti-emetic and laxative usage. The VAS consists of an individual subjective scale where each participant reports their level of pain from 0 to 10 where 0 = no pain, 5 = moderate pain and 10 = severe pain. Research information collected for this study consist of the VAS, opioid consumption, anti-emetic and laxative usage which are all information that is documented on standard protocol forms belonging to St Vincent’s Hospital (Observation Chart and Drug Chart). No new questionnaires or forms have been created for this study. Results from the 2 cohorts will then be collated and compared between the cohorts to see if adding a 48 hour infusion pump does reduce pain, opioid usage and length of stay.
Interventions
This study is a randomised control trial analysing the difference in pain and length of stay in patients who have undergone an anterior total hip replacement (THR) with 2 different modes of analgesia post-operatively. One group of participants (Group A) will receive local infiltration anaesthetic (LIA) whilst the second cohort (Group B) will receive LIA and a continuous infiltration of LIA via an elastomeric pump directly to the surgical site.
Participants in Group A will receive 0.2% Ropivacai
This study is a randomised control trial analysing the difference in pain and length of stay in patients who have undergone an anterior total hip replacement (THR) with 2 different modes of analgesia post-operatively. One group of participants (Group A) will receive local infiltration anaesthetic (LIA) whilst the second cohort (Group B) will receive LIA and a continuous infiltration of LIA via an elastomeric pump directly to the surgical site. Participants in Group A will receive 0.2% Ropivacaine 2mg/kg as a once-off infiltration directly to the wound site intra-operatively. Participants in Group B will also receive 0.2% Ropivacaine 2mg/kg as a once-off infiltration directly to the wound site intra-operatively as well as having a an elastometric pump containing 0.2% Ropivacaine directly inserted in the wound site to provide continuous infiltration. The elastometric pump will contain 400ml of Ropivacaine and be infused with a rate of 2-14ml/hr. The infusion rate will commence at 2ml/hr initially post-operatively and can be increased by the nursing staff if participants are complaining of increased pain and require further analgesia to help control this. The study aims to investigate whether adding a continuous infiltration of LIA to surgical patients post anterior THR adds any additional reduction in pain, reduction in opioid usage and reduced length of stay compared to LIA alone. 108 patients will be recruited from the private outpatient rooms of a consultant orthopaedic surgeon that specialises in anterior THR. Participants will be randomly computer generated into one of the two different cohort groups and will receive either LIA or LIA + Elastomeric pump post-operatively. The elastomeric pump will be placed intra-operatively and remain insitu for 48hours post-operatively. The current post-operative standard of care involves patients reporting verbal analogue pain scales (VAS) from zero to ten, daily physiotherapy and administration of analgesia by nursing staff. This current practice will remain unchanged in this study. Pain reported scales, length of stay and opioid usage will be recorded in the two cohorts and compared. Data will be correlated between the two cohorts and analysed to determine whether participants who had LIA + Elastomeric pump had a reduction in pain scales, opioid usage, and reduced length of stay.
Sponsors
Mr Phong Tran
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must be greater than 18 years old, have hip osteoarthritis as assessed by the principal investigator and able to give informed consent to undergo an Anterior THR.
Exclusion criteria
Allergy or intolerance to Ropivicaine, and patients who have been diagnosed with Chronic Regional Pain Syndrome (CRPS)
Outcome results
None listed