Postoperative Pain Severity, Incidence Of Chronic Pain And Its Impact On Daily Function Following Total Knee Replacements (TKR) At A Tertiary Cancer Institute
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tata Memorial Centre
- Enrollment
- 139
- Locations
- 1
- Primary Endpoint
- pain severity in the immediate post-operative period following oncologic TKRs
Study Overview
Brief Summary
After Institutional Review Board approval, adult patients scheduled for total knee arthroplasty (TKA) will be enrolled into the study after obtaining informed consent over a 24 month period. Interim analyses of cases who have completed the 6 month follow up as on 31st October, 2017 will be analyzed as part of the co- principle investigator's thesis. All consenting patients will be assessed for pain preoperatively, the first 3 post-operative days, at 1, 4 and 6 months from the date of surgery. Pain scores will be assessed using the Numerical Rating Scale during the 3 postoperative days. Pain will be managed by the Acute Pain Service team as per standard protocols.
The Brief pain inventory (BPI) (short form with translations, obtained with permission from MD Anderson), which assesses pain severity and its impact on daily functions will be administered to the patient in a language familiar to them, preoperatively, at 1, 4 and 6 months postoperatively.
The Musculoskeletal Tumour Society Score (MSTS) which evaluates the functional condition (impairment) after completed tumour treatment will be estimated at the end of 6 months from the date of surgery The painDETECT questionnaire (PD-Q) a quick, simple and reliable screening tool to identify the likelihood of a neuropathic pain component in patients and validated in various languages including Hindi and Marathi will be administered preoperatively and at 1, 4 and 6 months after surgery.
Details of postoperative chemotherapy and radiation will also be obtained from patient's notes and the electronic medical record. If the patient cannot follow up at the said intervals, the pain scores would be obtained telephonically and the BPI and PD-Q forms in prepaid envelopes would be given to them at discharge which they would have to duly fill in and post them to the given address at the appropriate intervals if they cannot visit the pain clinic. At the 6th month of follow up, they would be requested to visit the pain clinic for an assessment of MSTS score and completing the BPI and PD-Q.
INCLUSION CRITERIA:-
- Adult patients above 18 years of age, undergoing TKR
- Literate: able to read and write in at least one of the following languages English, Hindi and Marathi
- Willing to fill forms and post them and/or answer questions on phone
EXCLUSION CRITERIA:-
- Refusal of consent
- Cognitively impaired
- Revision TKRs (including cases with wound wash and nail spacer cementing)
Detailed Description
INTRODUCTION:- A Total Knee Replacement (TKR) or arthroplasty (TKA) is a complex procedure that requires an Orthopedic Surgeon to make precise measurements and skillfully remove the diseased portions of the bone, in order to shape the remaining bone to accommodate the knee implant. Knee Replacement Surgery is most commonly performed in people with advanced osteoarthritis and should be considered when conservative treatments have been exhausted. Oncologic TKRs are different from the routine TKRs in a way that the former involves a wide local resection of the bone and soft tissues, ranging from 10 to 20 cm, resection of muscles like the head(s) of biceps femoris, the gastrocnemius muscle, the intermuscular septa, the joint capsule, etc. to ensure negative margins along with the complete resection of the tumour, followed by a reconstruction of almost the same length as that resected, to restore function.
The most common indication for doing oncologic TKR is Osteogenic Sarcoma (OGS) of and around the knee joint. The distal femur and proximal tibia are among the most common sites for primary bone tumor. OGS is the most common bone cancer in the world in children and adolescents, and the eighth-most common form of childhood cancer, accounting for 4% of all childhood cancers worldwide. In India, the incidence varies from 4.7% to 11.6%, where this malignancy is associated with significant morbidity and mortality. Additional treatment involves chemotherapy which further delays the healing and recovery of the patient.
Surgery is a known risk factor for development of Chronic Post Surgical Pain(CPSP) which as per the definition given by Macrae and Davies, is defined by
- Pain developing after a surgical procedure.
- Pain of at least 2 months' duration.
- Other causes of pain excluded (e.g.- malignancy, infection, etc.).
- Pain continuing from a pre-existing pain problem excluded.
CPSP is a well known risk factor in many surgeries like (but not exclusive of)-
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients above 18 years of age, undergoing TKR
- •Literate: able to read and write in at least one of the following languages English, Hindi and Marathi
- •Willing to fill forms and post them and/or answer questions on phone
Exclusion Criteria
- •Refusal of consent
- •Cognitively impaired
- •Revision knee arthroplasty (including cases with wound wash and nail spacer cementing)
Outcomes
Primary Outcomes
pain severity in the immediate post-operative period following oncologic TKRs
Time Frame: First 3 postoperative days
Pain scores as per the numerical rating scale
Secondary Outcomes
- the proportion of patients who continue to have pain at 4 and 6 months post surgery(CPSP)(4 and 6 months after surgery)
- • To identify the type of pain (neuropathic component) persisting at 4 and 6 months after TKR(4 and 6 months from surgery)
- Impact of the pain on daily function(4 and 6 months after surgery)
Investigators
Dr Aparna Chatterjee
Professor
Tata Memorial Centre