Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 98 of 424 for:    Pregabalin

Evaluating the Role of Pregabalin in Reducing Opioid Requirement in Spinal Fusion Surgeries of Two or More Vertebrae

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03031340
Recruitment Status : Terminated (Incidence of AE)
First Posted : January 25, 2017
Results First Posted : October 10, 2018
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Singh Nair, Montefiore Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Spinal Fusion
Interventions Drug: Pregabalin
Other: placebo
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description placebo: placebo Pregabalin: On the day of the surgery, 1hour + 15 minutes before the surgery starts, the subject will receive either 300mg of pregabalin or a similarly packaged placebo. On post operative day one, 150 mg of pregabalin or placebo will be given in two doses 12hrs apart.
Period Title: Overall Study
Started 2 1
Completed 0 0
Not Completed 2 1
Arm/Group Title Placebo Pregabalin Total
Hide Arm/Group Description placebo: placebo Pregabalin: On the day of the surgery, 1hour + 15 minutes before the surgery starts, the subject will receive either 300mg of pregabalin or a similarly packaged placebo. On post operative day one, 150 mg of pregabalin or placebo will be given in two doses 12hrs apart. 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%
0
   0.0%
1
  33.3%
Male
1
  50.0%
1
 100.0%
2
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 1 participants 3 participants
2 1 3
1.Primary Outcome
Title Postoperative Opioid Requirement
Hide Description The primary objective of this study is to evaluate the role of three doses of pregabalin on intra and postoperative (48hrs) opioid requirements in patients undergoing fusion of two or more vertebrae.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Data not analyzed
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
placebo: placebo
Pregabalin: On the day of the surgery, 1hour + 15 minutes before the surgery starts, the subject will receive either 300mg of pregabalin or a similarly packaged placebo. On post operative day one, 150 mg of pregabalin or placebo will be given in two doses 12hrs apart.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Pain Using the Visual Analog Scale (VAS) Pain Score
Hide Description evaluate pain using the visual analog scale (VAS) pain score at two hrs post-op, the morning following surgery 24 hours and 48 hours post-op
Time Frame 2 hours, 24 hours, 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Data not analyzed
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
placebo: placebo
Pregabalin: On the day of the surgery, 1hour + 15 minutes before the surgery starts, the subject will receive either 300mg of pregabalin or a similarly packaged placebo. On post operative day one, 150 mg of pregabalin or placebo will be given in two doses 12hrs apart.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Incidence of 48 Hours Post Operative Nausea and Vomiting
Hide Description Find the incidence of 48 hours post operative nausea and vomiting in the target population
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Data not analyzed
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
placebo: placebo
Pregabalin: On the day of the surgery, 1hour + 15 minutes before the surgery starts, the subject will receive either 300mg of pregabalin or a similarly packaged placebo. On post operative day one, 150 mg of pregabalin or placebo will be given in two doses 12hrs apart.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Post Operative Cognitive Function
Hide Description 48 hours post operative headache, dizziness, sedation and blurred vision
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Data not analyzed
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
placebo: placebo
Pregabalin: On the day of the surgery, 1hour + 15 minutes before the surgery starts, the subject will receive either 300mg of pregabalin or a similarly packaged placebo. On post operative day one, 150 mg of pregabalin or placebo will be given in two doses 12hrs apart.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Pre-operative Anxiety
Hide Description Measure the level of pre-operative anxiety using the visual analog scale (VAS)
Time Frame 24 hours prior to surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Data not analyzed
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
placebo: placebo
Pregabalin: On the day of the surgery, 1hour + 15 minutes before the surgery starts, the subject will receive either 300mg of pregabalin or a similarly packaged placebo. On post operative day one, 150 mg of pregabalin or placebo will be given in two doses 12hrs apart.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Anesthesia Satisfaction
Hide Description To measure the level of overall anesthesia satisfaction among the two groups at discharge.
Time Frame 24 hours post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Data not analyzed
Arm/Group Title Placebo Pregabalin
Hide Arm/Group Description:
placebo: placebo
Pregabalin: On the day of the surgery, 1hour + 15 minutes before the surgery starts, the subject will receive either 300mg of pregabalin or a similarly packaged placebo. On post operative day one, 150 mg of pregabalin or placebo will be given in two doses 12hrs apart.
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 Placebo Pregabalin
Hide Arm/Group Description placebo: placebo Pregabalin: On the day of the surgery, 1hour + 15 minutes before the surgery starts, the subject will receive either 300mg of pregabalin or a similarly packaged placebo. On post operative day one, 150 mg of pregabalin or placebo will be given in two doses 12hrs apart.
All-Cause Mortality
Placebo Pregabalin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)      1/1 (100.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Pregabalin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      1/1 (100.00%)    
General disorders     
Death *  0/2 (0.00%)  0 1/1 (100.00%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Pregabalin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
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.Singh Nair
Organization: Montefiore Medical Center
Phone: 7189205932
Responsible Party: Singh Nair, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03031340     History of Changes
Other Study ID Numbers: 11-01-004
First Submitted: January 22, 2017
First Posted: January 25, 2017
Results First Submitted: September 13, 2018
Results First Posted: October 10, 2018
Last Update Posted: October 10, 2018