Pain, Postoperative Clinical Trial
Official title:
Postoperative Pain Severity, Incidence Of Chronic Pain And Its Impact On Daily Function Following Total Knee Replacements (TKR) At A Tertiary Cancer Institute
NCT number | NCT03032679 |
Other study ID # | 1780 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 2, 2017 |
Est. completion date | August 31, 2020 |
Verified date | October 2020 |
Source | Tata Memorial Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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)
Status | Completed |
Enrollment | 139 |
Est. completion date | August 31, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
India | Tata Memorial Centre | Mumbai | Maharashtra |
Lead Sponsor | Collaborator |
---|---|
Tata Memorial Centre |
India,
Ayers DC, Franklin PD, Ploutz-Snyder R, Boisvert CB. Total knee replacement outcome and coexisting physical and emotional illness. Clin Orthop Relat Res. 2005 Nov;440:157-61. — View Citation
Beswick AD, Wylde V, Gooberman-Hill R. Interventions for the prediction and management of chronic postsurgical pain after total knee replacement: systematic review of randomised controlled trials. BMJ Open. 2015 May 12;5(5):e007387. doi: 10.1136/bmjopen-2014-007387. Review. — View Citation
Haroutiunian S, Nikolajsen L, Finnerup NB, Jensen TS. The neuropathic component in persistent postsurgical pain: a systematic literature review. Pain. 2013 Jan;154(1):95-102. doi: 10.1016/j.pain.2012.09.010. Review. — View Citation
Jain P, Padole D, Bakshi S. Prevalence of acute neuropathic pain after cancer surgery: A prospective study. Indian J Anaesth. 2014 Jan;58(1):36-42. doi: 10.4103/0019-5049.126788. — View Citation
Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. Review. — View Citation
Mathieson S, Lin C. painDETECT questionnaire. J Physiother. 2013 Sep;59(3):211. doi: 10.1016/S1836-9553(13)70189-9. — View Citation
Nguyen MP, Buckwalter JA, Miller BJ. Patterns of improvement following oncologic reconstructrion compared to total knee arthroplasty and revision knee arthroplasty. Iowa Orthop J. 2011;31:160-5. — View Citation
Tunn PU, Pomraenke D, Goerling U, Hohenberger P. Functional outcome after endoprosthetic limb-salvage therapy of primary bone tumours--a comparative analysis using the MSTS score, the TESS and the RNL index. Int Orthop. 2008 Oct;32(5):619-25. Epub 2007 Aug 15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pain severity in the immediate post-operative period following oncologic TKRs | Pain scores as per the numerical rating scale | First 3 postoperative days | |
Secondary | the proportion of patients who continue to have pain at 4 and 6 months post surgery(CPSP) | As assessed from the brief pain inventory | 4 and 6 months after surgery | |
Secondary | • To identify the type of pain (neuropathic component) persisting at 4 and 6 months after TKR | Neuropathic component to be identified by using the pain Detect | 4 and 6 months from surgery | |
Secondary | Impact of the pain on daily function | Brief pain inventory and the MSTS score to assess the interference of pain with daily function and how it compares with MSTS at 6 month | 4 and 6 months after surgery |
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