scholarly journals Perineural local anaesthetic catheter after major lower limb amputation trial (PLACEMENT): results from a randomised controlled feasibility trial

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e029233 ◽  
Author(s):  
David Bosanquet ◽  
Graeme Ambler ◽  
Cherry-Ann Waldron ◽  
Emma Thomas-Jones ◽  
Lucy Brookes-Howell ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Local Anaesthetic ◽  
Lower Limb ◽  
Rating Scale ◽  
Lower Limb Amputation ◽  
Feasibility Trial ◽  
Limb Amputation ◽  
Effectiveness Trial ◽  
Randomised Controlled

ObjectivesTo determine the feasibility of undertaking a randomised controlled effectiveness trial evaluating the use of a perineural catheter (PNC) after major lower limb amputation with postoperative pain as the primary outcome.DesignRandomised controlled feasibility trial.SettingTwo vascular Centres in South Wales, UK.Participants50 patients scheduled for major lower limb amputation (below or above knee) for complications of peripheral vascular disease.InterventionsThe treatment arm received a PNC placed adjacent to the sciatic or tibial nerve at the time of surgery, with continuous infusion of levobupivacaine hydrochloride 0.125% for up to 5 days. The control arm received neither local anaesthetic nor PNC. Both arms received usual perioperative anaesthesia and postoperative analgesia.Primary and secondary outcome measuresThe primary outcomes were the proportion of eligible patients who were randomised and the proportion of recruited patients who provided primary effectiveness outcome data. Secondary outcomes were: the proportion of recruited patients reaching 2 and 6 month follow-up and supplying pain data; identification of key cost drivers; development of an economic analysis framework for a future effectiveness trial; identification of barriers to recruitment and site set-up; and identification of the best way to measure postoperative pain.ResultsSeventy-six of 103 screened patients were deemed eligible over a 10 month period. Fifty (64.5%) of these patients were randomised, with one excluded in the perioperative period. Forty-five (91.3%) of 49 recruited patients provided enough pain scores on a 4-point verbal rating scale to allow primary effectiveness outcome evaluation. Attrition rates were high; 18 patients supplied data at 6 month follow-up. Costs were dominated by length of hospital stay. Patients and healthcare professionals reported that trial processes were acceptable.ConclusionsRecruitment of patients into a trial comparing PNC use to usual care after major lower limb amputation with postoperative pain measured on a 4-point verbal rating scale is feasible. Evaluation of longer-term symptoms is difficult.Trial registration numberISRCTN: 85 710 690. EudraCT: 2016-003544-37.

scholarly journals Exploring patients’ experiences of analgesia after major lower limb amputation: a qualitative study

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e054618
Author(s):  
Sarah Milosevic ◽  
Heather Strange ◽  
Melanie Morgan ◽  
Graeme K Ambler ◽  
David C Bosanquet ◽  
...  
Keyword(s):  
Pain Management ◽  
Postoperative Pain ◽  
Pain Relief ◽  
Qualitative Study ◽  
Lower Limb ◽  
Lower Limb Amputation ◽  
Feasibility Trial ◽  
Limb Amputation ◽  
Face To Face ◽  
Randomised Controlled

ObjectivesTo explore patient experiences, understanding and perceptions of analgesia following major lower limb amputation.DesignQualitative interview study, conducted as part of a randomised controlled feasibility trial.SettingParticipants were recruited from two general hospitals in South Wales.ParticipantsInterview participants were patients enrolled in PLACEMENT (Perineural Local Anaesthetic Catheter aftEr Major lowEr limb amputatioN Trial): a randomised controlled feasibility trial comparing the use of perineural catheter (PNC) versus standard care for postoperative pain relief following major lower limb amputation. PLACEMENT participants who completed 5-day postoperative follow-up, were able and willing to participate in a face-to-face interview, and had consented to be contacted, were eligible to take part in the qualitative study. A total of 20 interviews were conducted with 14 participants: 10 male and 4 female.MethodsSemi-structured, face-to-face interviews were conducted with participants over two time points: (1) up to 1 month and (2) at least 6 months following amputation. Interviews were audio-recorded, transcribed verbatim and analysed using a framework approach.ResultsInterviews revealed unanticipated benefits of PNC usage for postoperative pain relief. Participants valued the localised and continuous nature of this mode of analgesia in comparison to opioids. Concerns about opioid dependence and side effects of pain relief medication were raised by participants in both treatment groups, with some reporting trying to limit their intake of analgesics.ConclusionsFindings suggest routine placement of a PNC following major lower limb amputation could reduce postoperative pain, particularly for patient groups at risk of postoperative delirium. This method of analgesic delivery also has the potential to reduce preoperative anxiety, alleviate the burden of pain management and minimise opioid use. Future research could further examine the comparison between patient-controlled analgesia and continuous analgesia in relation to patient anxiety and satisfaction with pain management.Trial registration numberISRCTN: 85710690; EudraCT: 2016-003544-37.

scholarly journals Perineural local anaesthetic catheter after major lower limb amputation trial (PLACEMENT): study protocol for a randomised controlled pilot study

Trials ◽  
2017 ◽  
Vol 18 (1) ◽  
Author(s):  
David C. Bosanquet ◽  
Graeme K. Ambler ◽  
Cherry-Ann Waldron ◽  
Emma Thomas-Jones ◽  
Lucy Brookes-Howell ◽  
...  
Keyword(s):  
Pilot Study ◽  
Study Protocol ◽  
Local Anaesthetic ◽  
Lower Limb ◽  
Lower Limb Amputation ◽  
Limb Amputation ◽  
Randomised Controlled

scholarly journals The Perineural Local Anaesthetic Catheter After Major Lower Limb Amputation Trial (Placement): A Randomised Controlled Feasibility Study

2019 ◽  
Vol 58 (6) ◽  
pp. e352
Author(s):  
Graeme K. Ambler ◽  
David C. Bosanquet ◽  
Cherry-Ann Waldron ◽  
Emma Thomas-Jones ◽  
Lucy Brookes-Howell ◽  
...  
Keyword(s):  
Feasibility Study ◽  
Local Anaesthetic ◽  
Lower Limb ◽  
Lower Limb Amputation ◽  
Limb Amputation ◽  
Randomised Controlled

scholarly journals Rates and risk factors for amputation in people with diabetes in Japan: a historical cohort study using a nationwide claims database

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Masanori Kaneko ◽  
Kazuya Fujihara ◽  
Mayuko Yamada Harada ◽  
Taeko Osawa ◽  
Masahiko Yamamoto ◽  
...  
Keyword(s):  
Lower Limb ◽  
Cox Regression ◽  
Lower Limb Amputation ◽  
Limb Amputation ◽  
Historical Cohort ◽  
Cox Regression Analysis ◽  
Claims Database ◽  
Younger Age

Abstract Background The prevalence of diabetes is rising, and diabetes develops at a younger age in East Asia. Although lower limb amputation negatively affects quality of life and increases the risk of cardiovascular events, little is known about the rates and predictors of amputation among persons with diabetes from young adults to those in the “young-old” category (50–72 y). Methods We analyzed data from a nationwide claims database in Japan accumulated from 2008 to 2016 involving 17,288 people with diabetes aged 18–72 y (mean age 50.2 y, HbA1c 7.2%). Amputation occurrence was determined according to information from the claims database. Cox regression model identified variables related to lower limb amputation. Results The mean follow-up time was 5.3 years, during which time 16 amputations occurred (0.17/1000 person-years). Multivariate Cox regression analysis showed that age (hazard ratio [HR] 1.09 [95% confidence intervals] 1.02–1.16, p = 0.01) and HbA1c (HR 1.46 [1.17–1.81], p < 0.01) were independently associated with amputations. Compared with those aged < 60 years with HbA1c < 8.0%, the HR for amputation was 27.81 (6.54–118.23) in those aged ≥60 years and HbA1c ≥8.0%. Conclusions Age and HbA1c were associated with amputations among diabetic individuals, and the rates of amputation were significantly greater in those ≥60 years old and with HbA1c ≥8.0%.

Lower limb amputation Part 3: Prosthetics - a 10 year literature review

2001 ◽  
Vol 25 (1) ◽  
pp. 21-28 ◽  
Author(s):  
H. Cochrane ◽  
K. Orsi ◽  
P. Reilly
Keyword(s):  
Literature Review ◽  
Lower Limb ◽  
Consensus Conference ◽  
Lower Limb Amputation ◽  
Limb Amputation ◽  
Amputation Surgery

This paper is intended as a follow-up to the ISPO Consensus Conference on Amputation Surgery. It reviews all the literature on lower limb prosthetics published after 1990. The review was considered under six categories: feet, knees, hips, thermoplastics, liners/suspension and computers.

scholarly journals Lower-Extremity Amputation: A 6-Year Follow-up Study in Brazil

2005 ◽  
Vol 13 (2) ◽  
pp. 164-166 ◽  
Author(s):  
JMP de Godoy ◽  
MF de Godoy ◽  
F Batigalia ◽  
ARF Trávolo ◽  
EHF Monteiro
Keyword(s):  
Lower Limb ◽  
Survival Curve ◽  
Lower Limb Amputation ◽  
Lower Limbs ◽  
Limb Amputation ◽  
First Year ◽  
Actuarial Survival ◽  
Critical Ischaemia ◽  
Leg Amputation

Purpose. To evaluate the 6-year mortality in 50 patients following lower-limb amputation. Methods. The cumulative survival rate of 50 (28 men, 22 women) amputees aged 54 to 94 years (mean, 67.3; median, 73.5) was retrospectively studied from 1993 to 1998. Indications for above- or below-knee amputation were trauma (n=2), vasculitis (n=2), and critical ischaemia of the lower limbs (n=46). Leg amputation was performed after anamnesis, physical examination, and angiography. All patients were followed up for 6 years by phone or domiciliary visit. A death certificate was verified when a patient was lost to follow-up. Statistical analysis was expressed by the actuarial survival curve. Results. Of 50 amputees, 36 died in the 6 years following leg amputation: 22 in the first year, 3 in the second year, 5 in the third year, 2 in the fourth year, 2 in the fifth year, 2 in the sixth year; 14 remained alive after 6 years. Conclusion. Patients who underwent lower-limb amputation had a high 6-year mortality. Most deaths occurred in the first year.

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