Perioperative Analgesia for Knee Arthroplasty (PAKA) - a pilot randomised trial
| ISRCTN | ISRCTN29107680 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29107680 |
| Protocol serial number | PAKA/PROTOCOL/V002 |
| Sponsor | University of Warwick (UK) |
| Funder | Astra Tech (UK) |
- Submission date
- 18/01/2011
- Registration date
- 01/06/2011
- Last edited
- 16/05/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Matthew Costa
Scientific
Scientific
University Hospitals Coventry & Warwickshire
Clinical Sciences Building 1st Floor
Clinical Sciences Reseach Institute
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot single centre standard of care controlled trial double blinded pragmatic randomised trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study acronym | PAKA |
| Study objectives | Peri-articular knee infiltration with Levobupivicaine 150mg, Morphine 10mg & Ketorolac 30mg reduces postoperative pain following primary total knee replacement compared with the current standard treatment of femoral nerve blockade |
| Ethics approval(s) | West Midlands Research Ethics Committee, REC Number: 10/H1208/37 Protocol number: PAKA/PROTOCOL/001 30 July 2010 |
| Health condition(s) or problem(s) studied | Muskuloskeletal, total knee arthroplasty, analgesia |
| Intervention | Femoral nerve block using 30ml of Levobupivicaine 0.25% versus Peri-articular infiltration of multimodal agents consisting of 150mg of Levobupivacaine, 10mg Morphine and 30mg Ketorolac diluted in 0.9% saline to make a volume of 100ml |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 1. Levobupivicaine 2. Morphine 3. Ketorolac |
| Primary outcome measure(s) |
Visual Analogue Scale at 18 hours post operation |
| Key secondary outcome measure(s) |
Serum Levobupivacaine levels pre & post retransfusion |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 46 |
| Key inclusion criteria | All patients undergoing an elective primary unilateral total knee replacement (TKA) under the care of an orthopaedic consultant at University Hospitals Coventry and Warwickshire NHS Trust |
| Key exclusion criteria | 1. Cognitive impairment, unable to complete questionnaire 2. Patients who lack capacity under the Mental Capacity Act 2005 3. Patients with pre-operative history of neruological abnormality in the ipsilateral leg e.g. history of stroke, neurogenic pain or previous nerve injury 4. Patients having spinal aneasthesia 5. Patients with specific contraindication to the analgesic agents used: Morphine, Ketorolac, Levobupivicaine |
| Date of first enrolment | 01/01/2010 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University Hospitals Coventry & Warwickshire
Coventry
CV2 2DX
United Kingdom
CV2 2DX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2012 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
