Health Condition 1: I798- Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere Health Condition 2: I738- Other specified peripheral vascular diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with ASA-I to III, physical status, aged 18 years or older 2. Patients undergoing elective or emergency major below knee amputation (BKA) 3. Patients capable of assessing pain using a Numerical Rating Scale (NRS)
Exclusion criteria
Exclusion criteria: 1. Patients with necrotizing fasciitis needing BKA 2. Patients undergoing Above Knee Amputation (AKA) or any other level of amputation (e.g., digital, metatarsal, tarsal, disarticulation of the hip) 2. Patients with an allergy or intolerance to any substances in the perineural catheter (PNC) or local anesthetic agents, or patients chronically taking class IB antiarrhythmic agents or local anesthetic agents in the form of transdermal patches. 3. Patients expected to be managed in the intensive care unit postoperatively and be sedated for more than 24 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study will be the successful placement of perineural catheters in patients undergoing below knee amputation. The catheter will be considered successfully placed if it provides adequate sensory coverage for pain relief and is free from any immediate complications after the procedure.Timepoint: Pre-op (Baseline), post-op at 8th hr, 16th hr, 24th hr, 32nd hr, 40th hr,48th hr,56th hr, 64th hr,72nd hr. | — |
Secondary
| Measure | Time frame |
|---|---|
| Advantage & Pain Relief: The study will evaluate the analgesic advantage offered by the perineural catheters in providing postoperative pain relief. Pain assessments using standardized scales like the Numerical Rating Scale (NRS) will be conducted at regular intervals to measure pain scores & assess the duration of pain relief achieved with the use of perineural catheters. Opioid Consumption: The study will also analyse opioid consumption in patients with perineural catheters to evaluate their impact on reducing the need for strong opioids for pain management in the postoperative period. Overall Patient Outcomes: The study will analyse the overall patient outcomes, including the length of hospital stay, postoperative complications, & functional recovery after below knee amputation, to determine the potential benefits of using perineural catheters in this surgical procedure.Timepoint: Pre-op (Baseline), post-op at 8th hr, 16th hr, 24th hr, 32nd hr, 40th hr,48th hr,56th hr, 64th hr,72nd hr. | — |
Countries
India
Contacts
Christian Medical College, Vellore