Clinical TrialParallelChronic PainKetamineNot yet recruiting

Evaluation of efficacy of ketamine for prevention of chronic pain in patients with Lower Limb amputation.

This randomised, parallel-group, participant- and investigator-blinded active-controlled trial (n=88) in India is assessing strategies to prevent phantom limb pain after lower limb amputation. The study compares a conventional pain management protocol with a multimodal analgesic approach, both including intravenous ketamine infusion at 0.15 mg/kg/hour continued for 48 hours post-operatively. The trial is designed to evaluate whether this perioperative analgesic regimen can reduce the development and severity of chronic pain following amputation. Primary outcomes focus on pain control in the immediate post-operative period and longer-term phantom limb pain. Within 48 hours, the investigators will measure pain severity using the visual analogue scale, opioid consumption, including total dose, number of doses, and time to first rescue analgesia. Phantom limb pain incidence and severity will then be assessed at 1, 3, and 6 months after surgery using the Phantom Pain Questionnaire. The study also includes psychological outcomes measured with the Hospital Anxiety and Depression Scale and the Pain Catastrophizing Scale. Secondary outcomes include adverse drug effects and patient satisfaction with pain management. No phase is specified.

Target Enrollment
88 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind

Study Arms & Interventions

Ketamine IV

experimental

Intervention1: Study group (Intravenous ketamine).: Study group will receive intravenous ketamine infusion at 0.15mg/kg/hr, will be continued post operatively for 48hrs.Control Intervention1: Compartor Group (Intravenous Ketamine): Compartor group will receive intravenous ketamine infusion at 0.15mg/kg/hr, will be continued post operatively for 48hrs

Interventions

  • Ketamine0.15 mg
    via IV

    Extracted from ChiCTR intervention description

Participants

Ages
??
Sexes
Male & Female

Inclusion Criteria

  • Inclusion criteria: 1. Patient aged 18-75years including male and female. 2. Scheduled for unilateral elective lower limb amputation(Above or Below Knee). 3. ASA physical Status I-III. 4. Consenting Patients.

Exclusion Criteria

  • Exclusion criteria: 1. Chronic Kidney Disease 2. History of Psychiatry illness affecting pain reporting. 3. Hypersensitivity or contraindication to study drugs. 4. Chronic Opioid use. 5. Pregnancy or Lactation.

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment88 participants
  • Timeline
    Start: 2026-04-23
    End: 2026-12-31
  • Compound
  • Topic

Locations

India