Pre-operative Pregabalin and Ketamine to Prevent Phantom Pain

NCT02311777 | Withdrawn Phase 3 DMC

• 1 other identifier: STU 092014-050
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Visual Analog Pain Scores (VAS)

  Pain will be evaluated immediate postoperative period and 6 months after surgery

  Postoperaive 6 months

Secondary Outcomes (1)

• Oral analgesic consumption

  1 months after surgery

Study Arms (2)

Pregabalin-ketamine

ACTIVE COMPARATOR

Pregabalin and ketamine will be given preoperative period

Drug: Pregabalin; Drug: Ketamine

Placebo

PLACEBO COMPARATOR

Placebo will be given preoperative period

Drug: Placebo

Interventions

Pregabalin DRUG

Pregabalin will be given orally during preoperative period

Also known as: Lyrica

Pregabalin-ketamine

Ketamine DRUG

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

Also known as: Ketamine hydrocloride

Pregabalin-ketamine

Placebo DRUG

Placebo will be given orally during preoperative period

Also known as: Placebo pregabalin/placebo ketamine

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ager 18-65 years old
• Unilateral lower-limb amputations
• Able to understand study procedures
• If on opioids, patient should be on a stable dose for at least one week prior to enrolment.
• Subject with normal renal function (CrCI \> 60 mL/min).

You may not qualify if:

• Cases with only digits amputation
• Current or recent history of alcohol and drug abuse
• Concomitant use of CYP 3A4 medications
• Unstable hypertension
• Abnormal EKG
• Increased intracranial pressure currently or in the past six months
• Increased intraocular pressure currently or in the past six months
• Liver disease or AST/ALT ≥ 3 ULN or total bilirubin \>2 x ULN
• Poorly controlled psychiatric illness.
• A history of seizure
• Using other anticonvulsant drug
• Renal impairment as determined by clinically significant labs
• Women of childbearing age who either has:
• A positive pregnancy test
• Unprotected heterosexual sex since their previous menses or;

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Pfizer: collaborator

Study Sites (2)

Parkland Health Hospital System

Dallas, Texas, 750390, United States

Location

UTSW, Parkland Hospital

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Phantom Limb

Interventions

Pregabalin; Ketamine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Dawood H Nasir, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 8, 2014
• Study Start: May 15, 2015
• Primary Completion: September 20, 2016
• Study Completion: September 20, 2017
• Last Updated: December 19, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)