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Pre-operative Pregabalin and Ketamine to Prevent Phantom Pain

NCT02311777 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2018-12-19

No results posted yet for this study

Summary

Phantom limb pain (PLP) is as painful sensations located to the missing limb and classified as neuropathic pain. In the United States, an estimated 1.7 million patients have undergone limb amputation, and 60% to 80% of these patients develop PLP (1-2) and it is usually resistant to a wide variety of treatments (1-4). Three factors may contribute to the development of persistent, post-amputation PLP by inducing central sensitization at different times relative to surgery: pre-amputation pain, noxious intraoperative stimuli, and acute postoperative pain (5-7).

Investigators hypothesis that pre-amputation period could be important in eliminating Phantom Limb Pain (PLP) in the patients in whom cortical reorganization is not yet established. The reduction of pre-operative pain and prevention of formation of pain memories may eliminate development of PLP by using dual networks treatment strategy. This Phase III, randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy of pre-operative pregabalin (lyrica) and ketamine in eliminating phantom limb pain in patients undergoing lower limb amputation.

Conditions

  • Phantom Pain

Interventions

DRUG

Pregabalin

Pregabalin will be given orally during preoperative period

DRUG

Ketamine

Ketamine will be given on the surgery day before the anesthesia induction

DRUG

Placebo

Placebo will be given orally during preoperative period

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Dawood H Nasir, MD · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-15
Primary Completion
2016-09-20
Completion
2017-09-20

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02311777 on ClinicalTrials.gov