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Effect of continuous injection of pain relief medication around nerves after amputations of the leg

Effect of Perineural Bupivacaine Infusion on Postoperative Opioid Requirement After Major Lower Limb Amputation: An Open-label Randomized Control Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/055331
Enrollment
124
Registered
2023-07-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L089- Local infection of the skin and subcutaneous tissue, unspecified Health Condition 2: I739- Peripheral vascular disease, unspecified

Interventions

Intervention1: Perineural Bupivacaine infusion after major lower limb amputation: Perineural catheter will be placed intra-op during major lower limb amputation and bupivacaine infusion administered f

Sponsors

JIPMER Intramural fund
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients (Age >= 18 years) undergoing elective or emergency major lower limb amputations

Exclusion criteria

Exclusion criteria: 1.Patients undergoing hip disarticulation, and hindquarter amputation. 2.Patients who have an allergy to bupivacaine 3.Patients are expected to be requiring sedation or ventilatory support for more than 24 hours. 4.Patients undergoing revision amputation who have been previously recruited into the study. 5.Patients undergoing bilateral amputations. 6.Patients in whom the appropriate nerve could not be identified. 7.Patients undergoing Guillotine amputation. 8.Patient denying consent

Design outcomes

Primary

MeasureTime frame
To determine the decrease in patientâ??s post-operative opioid requirement in those undergoing major lower limb amputation and receiving continuous perineural infusion of bupivacaine for three days compared to those receiving standard careTimepoint: Measured every 6h for 72h—

Secondary

MeasureTime frame
To determine and compare the postoperative continuous perineural infusion of Bupivacaine and standard management after major lower limb amputation for incidence of catheter-related complications (brocade, slippage, wound infections). Timepoint: duration of hospital stay;To determine and compare the postoperative continuous perineural infusion of Bupivacaine and standard management after major lower limb amputation for incidence of Phantom limb painTimepoint: 3 months post op;To determine and compare the postoperative continuous perineural infusion of Bupivacaine and standard management after major lower limb amputation for postoperative mean pain score assessed using the visual analog scale (VAS) for three days in both groups. Timepoint: 3 days—

Countries

India

Contacts

Public ContactJulia Sunil

JIPMER

reddy.kmc2k6@gmail.com8195014433

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026