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Randomized Controlled Trial of Ketamine Infusion With Continuous Epidural Infusion for Treatment of Complex Regional Pain Syndrome

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ClinicalTrials.gov Identifier: NCT02094352
Recruitment Status : Terminated (The study was unable to enroll efficiently despite trying various technique.)
First Posted : March 21, 2014
Results First Posted : June 14, 2017
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Complex Regional Pain Syndrome
Interventions Drug: Ketamine Infusion + Epidural Infusion
Drug: Control Group + Epidural infusion
Drug: Ketamine Booster Infusion
Drug: Control Group Booster Infusion
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketamine Infusion + Epidural Infusion + Booster Infusion Control Group + Epidural Infusion + Booster Infusion
Hide Arm/Group Description

Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.

Outpatient: Patients will receive three ketamine booster infusions over the course of three months.

Ketamine Infusion + Epidural Infusion: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.

Ketamine Booster Infusion: Patients will receive three ketamine booster infusions over the course of three months.

Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.

Outpatient: Patients will receive three saline booster infusions over the course of three months.

Control Group + Epidural infusion: The saline and epidural infusions will be administered over 96 hours with appropriate titration.

Control Group Booster Infusion: Patients will receive three saline booster infusions over the course of three months.

Period Title: Overall Study
Started 2 1
Completed 2 1
Not Completed 0 0
Arm/Group Title Ketamine Infusion + Epidural Infusion + Booster Infusion Control Group + Epidural Infusion + Booster Infusion Total
Hide Arm/Group Description

Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.

Outpatient: Patients will receive three ketamine booster infusions over the course of three months.

Ketamine Infusion + Epidural Infusion: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.

Ketamine Booster Infusion: Patients will receive three ketamine booster infusions over the course of three months.

Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.

Outpatient: Patients will receive three saline booster infusions over the course of three months.

Control Group + Epidural infusion: The saline and epidural infusions will be administered over 96 hours with appropriate titration.

Control Group Booster Infusion: Patients will receive three saline booster infusions over the course of three months.

Total of all reporting groups
Overall Number of Baseline Participants 2 1 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
1
 100.0%
3
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
Female
1
  50.0%
1
 100.0%
2
  66.7%
Male
1
  50.0%
0
   0.0%
1
  33.3%
1.Primary Outcome
Title Pain Reduction
Hide Description Evidence of changes in NRS pain scores between baseline and six months post infusion
Time Frame 6 months post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Study terminated early due to lack of enrollment. We did not analyze any data.
Arm/Group Title Ketamine Infusion + Epidural Infusion + Booster Infusion Control Group + Epidural Infusion + Booster Infusion
Hide Arm/Group Description:

Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.

Outpatient: Patients will receive three ketamine booster infusions over the course of three months.

Ketamine Infusion + Epidural Infusion: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.

Ketamine Booster Infusion: Patients will receive three ketamine booster infusions over the course of three months.

Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.

Outpatient: Patients will receive three saline booster infusions over the course of three months.

Control Group + Epidural infusion: The saline and epidural infusions will be administered over 96 hours with appropriate titration.

Control Group Booster Infusion: Patients will receive three saline booster infusions over the course of three months.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine Infusion + Epidural Infusion + Booster Infusion Control Group + Epidural Infusion + Booster Infusion
Hide Arm/Group Description

Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.

Outpatient: Patients will receive three ketamine booster infusions over the course of three months.

Ketamine Infusion + Epidural Infusion: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.

Ketamine Booster Infusion: Patients will receive three ketamine booster infusions over the course of three months.

Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.

Outpatient: Patients will receive three saline booster infusions over the course of three months.

Control Group + Epidural infusion: The saline and epidural infusions will be administered over 96 hours with appropriate titration.

Control Group Booster Infusion: Patients will receive three saline booster infusions over the course of three months.

All-Cause Mortality
Ketamine Infusion + Epidural Infusion + Booster Infusion Control Group + Epidural Infusion + Booster Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ketamine Infusion + Epidural Infusion + Booster Infusion Control Group + Epidural Infusion + Booster Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine Infusion + Epidural Infusion + Booster Infusion Control Group + Epidural Infusion + Booster Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Richman
Organization: HSS
Phone: 212.517.4481
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02094352     History of Changes
Other Study ID Numbers: 2013-003
First Submitted: December 23, 2013
First Posted: March 21, 2014
Results First Submitted: March 21, 2017
Results First Posted: June 14, 2017
Last Update Posted: January 31, 2018