Review Article

Pain Management in People with Diabetes-Related Chronic Limb-Threatening Ischemia

Table 1

Summary of pharmacological therapies related to ischemic pain management in patients with CLTI.

ReferenceStudy designParticipantsInterventionControlAdministration methodBaseline pain scoresPostintervention pain scoresStatistical differenceAdverse effects

Tedeschi et al. [66]Observational cohort studyTapentadol prolonged releaseNoneOral administration for 3 monthsMean NRS: Mean NRS: visit 2:
; visit 3: ; visit 4:
None
The European Study Group [67]Prospective, randomized, double-blind, placebo-controlled, parallel-group, multicentre trial (157 intervention, 157 control)Pentoxifylline solution: 600 mg in 500 ml of salineSaline: 500 mlIntravenous infusions twice a day for a maximum of 21 daysNumber (%) of patients
VAS median
Pentoxifylline: 40 (25-60)
Control: 40 (25-60)
Number (%) of patients
VAS median
Pentoxifylline: -22 (-42-0)
Control: -6 (-30-5)
Pentoxifylline vs. control: 95%Gastrointestinal symptoms (pentoxifylline: 59 cases vs. control: 18 cases; )
De Marchi et al. [68]RCT (24 intervention, 24 control)PLC solution: 600 mg in 250 ml of saline solutionSaline: 250 mlIntravenous twice a day for 15 daysMean VAS
Intervention:
Control:
Mean VAS
Intervention:
Control:
PLC vs. correspondent baseline: None
Veroux et al. [71]Open-label, nonrandomized study (group A: 25; group B: 31)Iloprost: group A: a continuous 6-hour 0.5 to 2.0 ng/kg·min once daily; group B: 20 days at a mean dosage of 25 pg/dNoneGroup A: IV infusion for at least 14 consecutive days; group B: a portable elastomeric infusion systemGroup A: 16
Group B: 16
Number of complete pain relief
Group A: 6
Group B: 11
Complete pain relief rate
Group A: 6/16 (37.5)
Group B: 11/16 (68.8)
Patients (40.0%) who experienced AEs. In group B, 2 of the 31 patients (6.5%) had hyperemia
Keskinbora and Aydinli [70]RCT (32 bupivacaine alone, 14 bupivacaine plus morphine)Bupivacaine plus morphine: 0.125% bupivacaine+10 mg morphine in 20 ml of salineBupivacaine alone: 0.125% bupivacaine in 20 ml of salinePopliteal catheter consecutivelyNRS scores (at rest)
Bupivacaine alone: ; bupivacaine plus morphine: ; NRS scores (during activity)
Bupivacaine alone:
Bupivacaine plus morphine:
NRS scores (at rest)
Bupivacaine alone: 60 min: ; 8 h: ; 12 h:
Bupivacaine plus morphine: 60 min: ; 8 h: ; 12 h:
NRS scores (during activity)
Bupivacaine alone: 60 min: ;
8 h: ; 12 h:
Bupivacaine plus morphine: 60 min: ; 8 h: ; 12 h:
NRS scores (at rest)
Bupivacaine alone: 60 min: ; 8 h: ; 12 h:
Bupivacaine plus morphine: 60 min: 001(vs. baseline); 8 h: (vs. baseline or vs. bupivacaine alone); 12 h: (vs. baseline or vs. bupivacaine alone)
NRS scores (during activity)
Bupivacaine alone: 60 min: ; 8 h: ; 12 h:
Bupivacaine plus morphine: 60 min: (vs. baseline); 8 h: (vs. baseline or vs. bupivacaine alone); 12 h: 001(vs. baseline or vs. bupivacaine alone)
Nausea in bupivacaine plus morphine: 1 (30% vs. 0%)

RCT: randomized controlled trial; CLI: chronic limb ischemia; PLC: propionyl-L-carnitine; VAS: visual analogue scale; NRS: numerical rating scale.